Our resource library is made available freely to all in order to advance responsible supply chain practices. Here you will find information and guidance on responsible supply chain issues and the way that the PSCI works. If you have any suggestions for improvements or additions to our resources please contact us.
The SAQ/Audit & Audit Guidance sub-team are pleased to publish the PSCI Pre-Audit Guidance Document Checklist. The checklist has been published as a separate document, previously found in the Audit Guidance as Annex 1.
The audit checklist summarizes important documents which the audit team may want to see in advance for audit preparation or want to review during the onsite audit visit. Depending on the type of supplier or the information provided as per SAQ, the list may be shortened (e.g. for service providers) or extended (e.g. for complex chemical or pharmaceutical manufacturers).
The checklist has been drafted using the current Full SAQ and Audit Report Template, suggesting documents that may be required for each principle (Governance & Management Systems, Ethics, Human Rights, Environment and Health & Safety) and corresponding question.
The Pharmaceutical Supply Chain Initiative (PSCI) and Accenture are pleased to announce the publication of the Decarbonization Playbook for the Pharmaceutical Industry (Playbook), an actionable playbook to guide pharmaceutical companies and their suppliers on the road to net zero.
Climate change poses the greatest health threat of the 21st century and the pharmaceutical industry is a key contributor to global emissions due to complex product lifecycles and an energy-intensive value chain.
Many pharmaceutical companies have set ambitious, science-based decarbonization goals but only 20% of life sciences companies are on track to achieve net zero by 2050. Advancing decarbonization can be slow as companies wrestle with various pain points across the product lifecycle but delays in decarbonizing expose companies to risks across the stakeholder landscape. Decarbonizing the pharmaceutical industry is a core component of the PSCI’s Environment Principle and PSCI members realize the importance of working together and with their suppliers across the whole value chain.
There have been several whitepapers published on the topic of health sector decarbonization. This Playbook builds on that work to provide 24 detailed emissions reduction initiatives across 7 impact areas that map to the drug development lifecycle. The initiatives were assessed in terms of addressability, emission reduction potential, implementation timeline, upfront cost, and regulatory complexity, and intervention adoption timeframe.
We welcome your feedback. If you have any input on the Playbook, please contact us for consideration in future updates.
EXCEL VERSION WITH IMPORT SHEET (FOR ONLINE SAQ ONLY)
PSCI Self Assessment Questionnaire and Audit Report Template for Service Providers & General Manufacturers with import sheet.
For optimum functionality, we recommend using the most up to date version Microsoft Excel. If you only have access to Excel 2003 or earlier, we recommend using the Word version of the SAQ.
To access the offline abbreviated SAQ template and full version history of the SAQ, follow this link.
Content version 8.0, simplified the Categorisation of Suppliers (Category A, B or C), removed/ added a few questions, rewording some questions, December 2021. Import sheet incorporated July 2023. Content version 9.0, full review and update of the SAQ. Section names and all questions revised to reflect the updated PSCI Principles, September 2024. Import sheet incorporated December 2024.
Full version template for Core Suppliers, External Manufacturers, Component and Material Suppliers are also available and come in multiple languages: Excel version full.
Please note: Content version 9.0 is only currently available in English with translations to follow soon.
The previous version of the SAQ is currently available in the following languages:
Español | Spanish
中文 (简体) | Chinese (simplified)
Português | Portuguese
日本語 | Japanese
The following links provide SAQ Online instruction documents for:
THE PSCI PRESENTS ITS SECOND PUBLIC AUDIT FINDINGS REPORT, PROVIDING CONTINUED INSIGHTS INTO SUPPLIER RISKS, TRENDS, AND AREAS FOR IMPROVEMENT ACROSS THE PHARMACEUTICAL AND HEALTHCARE SUPPLY CHAIN.
This report shares our analysis of findings from PSCI audits available on our platform. Each year, we review these in line with the PSCI Principles to identify trends, highlight improvements, and share recommendations. Overall, this analysis provides deep insight into supplier practices within the pharmaceutical and healthcare industry and guides us on developing targeted resources and trainings.
The year’s report analyzes 1,776 findings from 180 supplier audits uploaded to the PSCI platform in 2023. These findings are categorized into 308 Management Systems findings, 7 Ethics findings, 169 Human Rights findings, 970 Health & Safety findings, and 322 Environment findings, offering a comprehensive overview of supplier practices and opportunities for improvement. The report includes a summary of findings across key topics, detailed breakdowns with recommended actions for suppliers, and links to relevant
What’s new this year?
The first-ever analysis by supplier type, providing tailored insights into specific supplier categories.
A regional analysis focused on major pharmaceutical manufacturing hubs, including China and India.
A deep-dive analysis of 13 suppliers’ audit data over three years, exploring changes in supplier practices and measuring PSCI’s impact.
The report reinforces the PSCI’s role as a catalyst for continuous improvement, equipping suppliers with tools and guidance to enhance practices and adapt to evolving demands. For more details, access the full report in the resource attached.
You're Invited: PSCI Global Supplier Conference 2025!
Get ready for a highly regarded line-up of expert speakers, insightful discussions, and actionable strategies to drive sustainability in pharmaceutical supply chains.
🔎 Featured Sessions:
Legislation & Trends – Stay ahead of key legislation on Wastewater, Due Diligence, and Human Rights, and explore current pressures on the pharmaceutical industry related to antimicrobial resistance
Hands-On Solutions – Explore practical strategies on cybersecurity in process safety, data integration in risk assessments, safety excellence, and more!
PSCI Showcase – Gain insights into the Pharma LCA and PSCI’s Decarbonization Partnerships
📅 Download the full agenda below. To register, click here.
Don’t miss this opportunity to connect, learn, and contribute to the future of sustainable value chains. Secure your spot today and make every session count!
📩 Spread the Word: Forward this invitation to your colleagues.
If you have any questions, feel free to reach out at info@pscinitiative.org.
The first session of the 2024 PSCI China Supplier Conference took place on September 10, covering Management, Human rights & labor, and Decarbonization.
2024年中国供应商大会第一天于成都线下举行，覆盖管理体系、劳工、减碳议题。
Speaker:
Jennifer Jiang | Partner | ERM
演讲嘉宾：
姜煜瑶 | 合伙人 | 伊尔姆
Topic: Scope 3 and Decarbonization
议题：范围三和脱碳
To access the slides, please click "DOWNLOAD". 下载会议PPT，请点击下方DOWNLOAD按钮
The first session of the 2024 PSCI China Supplier Conference took place on September 10, covering Management, Human rights & labor, and Decarbonization.
2024年中国供应商大会第一天于成都线下举行，覆盖管理体系、劳工、减碳议题。
The first session of the 2024 PSCI China Supplier Conference took place on September 10, covering Management, Human rights & labor, and Decarbonization.
2024年中国供应商大会第一天于成都线下举行，覆盖管理体系、劳工、减碳议题。
Speaker:
Lin Wang, Director, BSR China
演讲嘉宾：
王林，中国区总监，商业社会责任
Topic: China labor market practice and impact to business
议题：中国劳动市场的实践以及对商业的影响
To access the slides, please click "DOWNLOAD". 下载会议PPT，请点击下方DOWNLOAD按钮
The first session of the 2024 PSCI China Supplier Conference took place on September 10, covering Management, Human rights & labor, and Decarbonization.
2024年中国供应商大会第一天于成都线下举行，覆盖管理体系、劳工、减碳议题。
Speaker:
Jason Jiang| EHS Lead| GSK
Eric Peng| Regional Category Manager| Astra Zeneca
演讲嘉宾：
姜兴| EHS负责人 | 葛兰素史克
彭诗达| 亚太区采购经理 | 阿斯利康
Topic: Human Rights Audits Common Findings & CAPs
议题：劳动者权益审计常见发现项&整改方案| 劳动者权益话题分享
To access the slides, please click "DOWNLOAD". 下载会议PPT，请点击下方DOWNLOAD按钮
The first session of the 2024 PSCI China Supplier Conference took place on September 10, covering Management, Human rights & labor, and Decarbonization.
2024年中国供应商大会第一天于成都线下举行，覆盖管理体系、劳工、减碳议题。
Speaker:
Jing DONG | Managing Director | Peterson Solutions China
演讲嘉宾：
董菁 | 总经理 | 上海佩笙检测有限公司
Topic: Social Sustainability in Upstream Supply Chain via Responsible Sourcing Process
议题：通过负责任采购实现上游供应链中的社会可持续发展
To access the slides, please click "DOWNLOAD". 下载会议PPT，请点击下方DOWNLOAD按钮
The first session of the 2024 PSCI China Supplier Conference took place on September 10, covering Management, Human rights & labor, and Decarbonization.
2024年中国供应商大会第一天于成都线下举行，覆盖管理体系、劳工、减碳议题。
Speaker:
Gary Lu | APAC SHE & Sustainability Director | AstraZeneca
演讲嘉宾：
卢罡 | 亚太区安全健康环保及可持续发展总监 | 阿斯利康
Topic: China Green Power Project
议题：中国绿电项目
To access the slides, please click "DOWNLOAD". 下载会议PPT，请点击下方DOWNLOAD按钮
The first session of the 2024 PSCI China Supplier Conference took place on September 10, covering Management, Human rights & labor, and Decarbonization.
2024年中国供应商大会第一天于成都线下举行，覆盖管理体系、劳工、减碳议题。
Speaker:
Joyce Jiang| Sr Sustainability & Compliance manager, Global Procurement| Roche (Shanghai) Pharmaceuticals Consulting Co.,Ltd.
演讲嘉宾：
蒋南婧 | 全球采购-可持续发展与合规高级经理 | 罗氏（上海）医药咨询有限公司
Topic: Roche’s Journey to Decarbonise its Supply Chain - Challenges & Mitigation
议题：罗氏供应链的减碳之旅-挑战和行动
To access the slides, please click "DOWNLOAD". 下载会议PPT，请点击下方DOWNLOAD按钮
The second session of the 2024 PSCI China Supplier Conference took place on September 11, covering Environment, Industrial Hygiene, General Safety, and Process Safety.
2024年中国供应商大会第二天于南京线下举行，覆盖环境、工业卫生、安全总览、过程安全议题。
Speaker:
Don Yu| BD Manager| BSI
演讲嘉宾：
于东 | 商务经理 | 英国标准协会
Topic: BSI Kitemark™ for minimized risk of antimicrobial resistance
议题：BSI与抗生素耐药性认证
To access the slides, please click "DOWNLOAD". 下载会议PPT，请点击下方DOWNLOAD按钮
The second session of the 2024 PSCI China Supplier Conference took place on September 11, covering Environment, Industrial Hygiene, General Safety, and Process Safety.
2024年中国供应商大会第二天于南京线下举行，覆盖环境、工业卫生、安全总览、过程安全议题。
The second session of the 2024 PSCI China Supplier Conference took place on September 11, covering Environment, Industrial Hygiene, General Safety, and Process Safety.
2024年中国供应商大会第二天于南京线下举行，覆盖环境、工业卫生、安全总览、过程安全议题。
Speaker:
William Zhu | Associate Director | WSP
演讲嘉宾：
朱人 | 副技术总监 | 科进
Topic: Statistical Analysis of Industrial Hygiene Monitoring Data
议题：工业卫生数据的统计分析
To access the slides, please click "DOWNLOAD". 下载会议PPT，请点击下方DOWNLOAD按钮
The second session of the 2024 PSCI China Supplier Conference took place on September 11, covering Environment, Industrial Hygiene, General Safety, and Process Safety.
2024年中国供应商大会第二天于南京线下举行，覆盖环境、工业卫生、安全总览、过程安全议题。
The first session of the 2024 PSCI China Supplier Conference took place on September 11, covering Environment, Industrial Hygiene, General Safety, and Process Safety.
2024年中国供应商大会第二天于南京线下举行，覆盖环境、工业卫生、安全总览、过程安全议题。
Speaker:
Carl Deng | Senior Process Safety Consultant | DEKRA Shanghai Office
The 2024 PSCI India Supplier Conference in Goa brought together over 700 participants for three days of insightful discussions and networking. Featuring keynote speeches from industry leaders, expert panels, PSCI’s first-ever exhibition, and an auditors' panel, the conference showcased the PSCI’s commitment to advancing responsible supply chain practices.
This slide deck, presented by N T Prasad, Head EHSS Bangalore, Syngene International Limited during the "Process Safety" session at the PSCI India Supplier Conference 2024 in Goa, India.
This resource covers key trends, challenges, and best practices relevant to PSCI members and suppliers, the resource is designed to enhance understanding, with actionable strategies and case studies relevant to India and the broader region. Perfect for those looking to deepen their knowledge in sustainable supply chain management and industry collaboration.
The Pharmaceutical Supply Chain Initiative (PSCI) has released its 2023 Annual Report, celebrating its 10th anniversary and showcasing the efforts of the pharmaceutical and healthcare industry to build responsible supply chains. The report showcases the sector’s progress through its three modes of impact: Audit, Capability, and Projects.
More Info…
Audit
Reducing the burden on suppliers through an industry-supported audit framework and sharing platform
983 audits available on the PSCI shared audit platform
7000+ downloads of audits by the PSCI membership
Capability
Supporting continual supplier improvement through engaging, educational content
1800+ attendees on our webinar program, our largest audience ever
900 attendees joined two Supplier Conferences delivered in-person in China & India and first-ever Global Conference for suppliers in Europe and North America
Launch of a new, on-demand e-learning platform for suppliers, Learnster
Projects
Leveraging reach and scale to create positive impact
Launch of a progressive position paper on Horseshoe Crab blood usage for the sector
Development of a new Supplier Partnership category to recognize suppliers that can evidence their commitment to responsible practices
Ingrid Vande Velde, 2023 PSCI Chair says,
When our founding members joined together in 2013, they had a vision of crystallizing their collective knowledge to create a transparent, efficient, and sustainable supply chain. Reflecting on the past decade, it’s clear that we’ve made tremendous advances towards that original vision, and understand what remains to be achieved on the road ahead.
Deirdre O’Reilly, 2024 PSCI Chair says,
Reflecting on the achievements of 2023, it’s impressive and humbling to see the sheer energy and dedication of the members that drive the PSCI, especially those in leadership roles for our various Committees and Teams. Their commitment fuels the PSCI’s success and our energy for the future.
Address for correspondence is: LinkRFP@pscinitiative.org
Please confirm your interest to participate by: 10th May 2024
Bid submission deadline: 31st May 2024
PSCI has conducted a materiality review for the sector every few years (2013, 2017, 2020). We are pleased to publish our latest assessment, this time applying a double materiality framework. The assessment is specifically focused on supply chains for the Pharmaceutical & Healthcare industries, and takes into account member views and a range of outside sources. (For more detail about the double materiality approach, please see here.)
The initial materiality was conducted in Summer 2023 to support development of the new strategy. This has since been updated to take into take into account the final CSRD and to add an additional checking stage to the scoring and issues list.
We encourage members, suppliers and our other stakeholders and invited to read the report and use it as an input to their own planning processes.
For anyone with comments to the report, please contact Rosie.Towe@Carnstone.com.
The PSCI shares its first public Audit Findings Report, providing insight and visibility over key risks, trends, and improvements in the pharmaceutical and healthcare supply chain.
As part of the PSCI's goal to promote consistency, quality, and innovation in all aspects of supplier evaluation and audit, we analyze PSCI audits conducted and uploaded on our shared platform on an annual basis. This report shows what we’ve found by analyzing 3,500 findings from 339 PSCI audits conducted during 2020-2022 and uploaded to the PSCI platform by the end of 2022.
We are specifically interested in understanding how the findings are distributed across the five areas of the PSCI Principles, our blueprint for responsible supply chain management & foundation of our tools. This analysis gives us visibility over how findings are changing over time and our impact on the industry.
This report, the first we have shared publicly, shows the results of a deep dive analysis into each area, focusing on 1,955 findings from 195 PSCI audits uploaded by the end of 2022. These findings reveal key risks, areas for improvement, and opportunities for PSCI members to support their suppliers to improve their practices.
This analysis also provides a high-level understanding of regional differences and levels of maturity, allowing us to provide regionally specific support on hot topics through our capability building work and begin to understand our own impact on the industry.
Speaking of the report's publication, Dorota Wiacek-Trojanowska, Audit Committee member says,
The annual analysis of audit results carried out by the PSCI not only provides information enabling the identification of the most important challenges faced by both PSCI members and suppliers, but also shows new challenges that we must be able to face. The audit results give us the opportunity to collect and analyze information on the biggest challenges in ensuring a sustainable supply chain in the whole pharma sector.
The PSCI has published our 2022 Annual Report, summarizing a year of growing connections and clear movement towards achieving our shared vision of excellence in safety, environmental, and social outcomes across the global pharmaceutical and healthcare supply chain.
Key developments in 2022 include
Growth to 74 members (an increase of 40% on 2021), with 18 new Associate members
Developed the PSCI Maturity Models to support structured supplier learning, and in early 2023 launched an app called PSCI Maturity (available in both the Android and iOS stores)
32% increase in audits available on the PSCI platform; 801 total & 196 new audits uploaded in 2022
Over 2,100 supplier attendees at our capability building conferences in India and China
Became the Official Sustainability Partner of CPHI Worldwide
Vicki Stone-Bjarup, 2022 Chair of the PSCI, says,
Sectors around the world are working to tackle the sustainability challenges of their industry. This report transparently shares the successes that PSCI members have achieved for our sector over the last year, as well as the journey left to take. There is still a long way to go, but we are so proud to be a part of the progress being made in the pharmaceutical industry. Our focus remains to support our members to build responsible supply chains.
Decarbonizing the pharmaceutical industry in line with global efforts is a core component of PSCI’s environmental principle. Action is needed and PSCI members realize the importance of working together with their suppliers, often the majority of the footprint across the whole value chain.
This is why we're pleased to launch the PSCI Decarbonization Pathway, a tool that the industry can use to move towards a net zero value chain, in line with global goals such as the COP Paris Agreement and UN Sustainable Development Goals. The maturity model provides a clear pathway for suppliers to develop their capability and response towards reducing their carbon emissions.
PSCI Members, through their Decarbonization team and partnerships with leading organisations, will continue to provide the resources that suppliers will need in this journey.
In this video, the PSCI reiterates its commitment to supporting our members to understand human rights practices in pharmaceutical supply chains and outlines the resources available to help make it happen across the industry.
Together with our members, the PSCI understands that society and business are best served by responsible business behaviors and practices. With our training materials, conferences, and tools, we aim not only to ensure the upholding of our Principles, but also to support all our members in implementing the United Nations’ Guiding Principles on Business and Human Rights in their supply chain and improving their human rights impacts around the world.
The first session of the 2022 PSCI China supplier conferences took place virtually on 6 September and covered Ethics, Labor, Management systems.
2022年中国供应商线上会议第一场于9月6日在线上举行，覆盖伦理，劳工，管理议题。
Speaker: Roderick | Technical director | Shanghai STRM Technology Co., Ltd.
演讲嘉宾：员文权 | 技术总监 | 上海翊员科技有限公司 Topic: Business continuity plan
议题：业务连续性计划
The third session of the 2022 PSCI India supplier conferences took place in-person on the 23rd of September and covered Human Rights & Labor and Ethics.
The full slide deck is available for download below.
The presentations covered are as follows:
PSCI Human Rights & Labor Maturity Model Dinesh Subhedar, Head of Third Party Labor Rights - India & West Asia, Novartis Alexandrea Kunde, Partner, PSCI Secretariat – Carnstone Partners Ltd.
Responsible Procurement Ashish Mohan | Vice President – Procurement, BSV Group
Psychological Safety Rishu Roy, Chairperson, ISTD (Indian Society of Training and Development) Indore Chapter | Professor, Shri Vaishnav Vidyapeeth Vishwavidhayalaya
Management of Change – Application of Digital Tools Anjali Sandesh, Associate Director, Benchmark ESG Naveen GV, Corporate Officer & Manager Director, Benchmark ESG
Data Privacy – General Introduction and Legislations Neeru Walia, Associate Director, Deloitte Sowmya Vedarth, Partner, Deloitte
The second session of the 2022 PSCI India supplier conferences took place in-person on the 22nd of September and covered Audit, Environment, Scope 3, PiE/AMR
The full slide deck is available for download below.
Engaging Suppliers to Reduce Scope 3 Emissions Towards Net Zero Robert Williams, Director of Procurement Sustainability, Astra Zeneca
Ban on Identified Single Use Plastic – The Whats, Whys and Hows Ashish Jain, Founder-Director, Indian Pollution Control Association (IPCA)
Climate change – Risks to Organizations Shivananda Shetty, Partner & Head, ESG and Climate Change, KPMG
Supplier Water Quality & Pharmaceuticals in Environment Balaji Gurumurthy, Environmental Compliance Lead, Novartis
Reducing AMR Risk Through Effective Control of Antibiotic Manufacturing Emissions Dharmesh Kharwar, Director, NGB Laboratories
PSCI Musi River Project Manjit Singh, Associate Director of Corporate Sustainability, Centrient Pharmaceuticals Senthil Kumar, Supplier Operations, Pfizer
Case studies – Implementation of Good Practice in Management of API Containing Waste Streams Ashok Kumar Podisetty, Head of EHS, Neuland Laboratories Limited
Developing PiE/AMR Capabilities in India Aditya Shirodkar, Global Senior EHS Specialist, Abbott
The first session of the 2022 PSCI India supplier conferences took place in-person on the 21st of September and covered Safety and Process Safety Management.
The full slide deck is available for download below at "View More".
The presentations covered are as follows:
PSCI Safety Principle - Supplier Maturity Model Vijaya Sarathy, EHS Manager, West Pharmaceuticals Services
Business Continuity Plans Ranjana Ganguly, EHS Vice President - India, Pfizer Amish Kamat, EHS Regional Manager - APAC, Bayer Dr JVN Reddy, President, Aurobindo Vijaya Sarathy, EHS Manager, West Pharmaceuticals Services Declan Kielty, Business Resilience Leader, Pfizer
Process Safety Management: General Introduction Vijaya Kumar Bendi, Manager-ESE, HS&S, Johnson & Johnson
Hazardous Area Classification M. Sasikumar, General Manager, Cholamandalam MS Risk Services
Approach for Implementing Risk Based Process Safety Management Systems as per Centre for Chemical Process Safety Sivala Ravi Kiran, Head of Corporate EHS & Sustainability, Biocon
The PSCI is pleased to introduce the Maturity Models in this informative video. The Maturity Models are a very useful tool for suppliers to evaluate their current practices and plot a course for improvement. They allow users to evaluate their company practices against the PSCI Principles and signpost the user to the resources needed to progress.
The PSCI is pleased to introduce the Maturity Models in this informative video. The Maturity Models are a very useful tool for suppliers to evaluate their current practices and plot a course for improvement. They allow users to evaluate their company practices against the PSCI Principles and signpost the user to the resources needed to progress.
Surrogates such as naproxen sodium, lactose and mannitol are used in place of an API to determine particulate containment provided by a containment equipment such as an isolator. Selection of a surrogate, surrogate properties (moisture content, particle size distribution), methods for surrogate monitoring, locations of area positional samples, and Containment Performance Target (CPT) concentrations, are critical in the decision making, among other factors. The speakers will share surrogate monitoring methods utilizing ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment.
The webinar was created by:
• Maharshi Mehta, CIH, CSP, FAIHA, President
• Ankit Sharma, CIH, LFOH, Associate Director, International Safety Systems, Inc (ISS)
Today the PSCI published its 2021 Annual Report, summarizing a year of exceptional advancement towards achieving our shared vision of excellence in safety, environmental, and social outcomes across the global pharmaceutical and healthcare supply chain.
Key developments in 2021 include:
Growth in membership, with 53 member companies adopting the PSCI Principles
Increased audit sharing, with 116 new audits uploaded to our bespoke audit sharing platform
Finalization of our master supplier learning curriculum, with the launch of our eight maturity models for suppliers to use to advance their practices
Unprecedented levels of supplier engagement through two large-scale Virtual Supplier Conferences in China and India, reaching 2,000+ attendees
Promising insights on our impact on the industry, with preliminary analysis on audit data showing that our influence supports positive change on supplier practices
Manjit Singh, 2021 PSCI Chair and Associate Director of Corporate Sustainability at Centrient Pharmaceuticals says,
2021 was a year of spectacular growth for the PSCI in membership and activity. Despite the second year of the Covid-19 pandemic, every aspect of the PSCI's program developed and grew from our shared audits to our supplier capability interactions. I have appreciated the professional and energetic contribution of my fellow PSCI members and watched with great pride the growth of the organization and the impact it has upon our entire industry.
You can read about these advancements and more in the report below.
We welcome comments and encourage you to share this report with your networks using the hashtag #PSCIAnnualReport.
The PSCI is pleased to continue supporting the work of the Telangana State Government in India to revitalize the Musi River.
The Musi River flows through Hyderabad in Telangana State, Southern India. It is fed by the world-heritage Hussein Sagar lake, also called the “heart of the world”, and used to be enjoyed by locals and tourists alike for its beauty and amenity. Yet, there have been numerous reports of polluted effluents and poor wastewater management practices affecting the lake and the Musi River watershed, impacting local communities over many years.
For World Water Day 2021 (22 March), we published a statement outlining our support for the State government's initiative and our plans to help. We aimed to use our influence to engage with suppliers of PSCI members in Telangana to promote better wastewater practices and encourage positive change. Our aim is that every single supplier with a connection to a PSCI member should be visited, audited or contacted directly to promote the best technologies for wastewater management.
One year later, we're pleased to share an update on progress made. Since March 2021, we have
Held dedicated sessions on wastewater treatment technology at our Virtual Supplier Conference in India
Created a baseline of all pharmaceutical companies in the Musi River catchment area to identify connections with PSCI member companies
Our aim is that all suppliers to PSCI members should provide information about their wastewater treatment practices, either via member visit, questionnaire, or a full site audit shared on our platform.
To continue this work, we will
encourage suppliers to share audits and work with our members to encourage site visits or audits
offer audits free of charge to suppliers in the Musi River catchment area
promote our PEC:PNEC calculator for assessing API discharges
We hope to contribute to restoring the Musi River to its former health.
The Audit Committee has recently conducted a light refresh on the SAQ/Audit Excel template, and the Audit Guidance document. The new versions are now available on the Link.
This webinar covered the following topics:
Updates to the SAQ/Audit templates
Updates to the Audit Guidance documents
Latest news from Audit Committee, including plan to move the SAQ online
At the PSCI, we’re committed to supporting all our members to implement the United Nations’ Guiding Principles on Business and Human Rights (UNGPs) as part of our mission to drive excellence in safety, environmental, and social outcomes across the pharmaceutical and healthcare supply chain.
That’s why for Human Rights Day (10 December), we’re excited to launch our new Position Statement, which provides an overview of the role we play in helping our members and suppliers align their practices with the UNGPs through the PSCI Principles for Responsible Supply Chain Management and our resources.
With our training materials, webinars, and tools we aim not only to ensure the upholding of our Principles, but also to support all our members in implementing the UNGPs across their entire supply chains.
EXCEL VERSION
PSCI Self Assessment Questionnaire and Audit Report Template for Core Suppliers, External Manufacturers, Component and Material Suppliers
For optimum functionality, we recommend using the most up to date version Microsoft Excel. If you only have access to Excel 2003 or earlier, we recommend using the Word version of the SAQ.
Content Version 6, February 2019
Content Version 7, remote audit options added, October 2020
Content version 7.1, small technical fixes, including correctly referencing finding type on CAP tab, showing suppliers responses to topic areas that are not audited, May 2021
Content version 7.2, fix formating issue of finding classifications on the Company Specific Questions tab, June 2021
Content version 8.0, simplified the Categorisation of Suppliers (Category A, B or C), removed/ added a few questions, rewording some questions, December 2021 Content version 9.0, full review and update of the SAQ. Section names and all questions revised to reflect the updated PSCI Principles, September 2024.
Abbreviated version template for Service Providers & General Manufacturers are also available: Excel version.
Please note: Content version 9.0 is only currently available in English with translations to follow soon.
The previous version of the SAQ is currently available in the following languages:
EXCEL VERSION
Abbreviated PSCI Self Assessment Questionnaire & Audit Report Template for Service Providers & General Manufacturers
For optimum functionality, we recommend using the most up to date version Microsoft Excel. If you only have access to Excel 2003 or earlier, we recommend using the Word version of the SAQ.
Content Version 6, February 2019
Content Version 7, remote audit options added, October 2020
Content version 7.1, small technical fixes, May 2021
Content version 7.2, fix formating issue of finding classifications on the Company Specific Questions tab, June 2021
Content version 8.0, simplified the Categorisation of Suppliers (Category A, B or C), removed/ added a few questions, rewording some questions, December 2021 Content version 9.0, full review and update of the SAQ. Section names and all questions revised to reflect the updated PSCI Principles, December 2024.
Full version template for Core Suppliers, External Manufacturers, Component and Material Suppliers are also available and come in multiple languages: Excel version.
Mitigate pharmaceuticals in production wastewater : PIE theoretical evaluation, testing and treatment technologies Dr. Reinhold Maeck，Head of Corp EHS Regulatory Intelligence, BI Corporate EHS&S Li Liu , EHS Manger, BI China EHS&S
生产废水中的药物移除 : 环境中的药物理论评估与检测 Dr. Reinhold Maeck，公司EHS法规智能主管，勃林格殷格翰
刘立，EHS经理，勃林格殷格翰
The fourth session of the 2021 PSCI China supplier conferences took place virtually on 17 September and covered Safety, Process Safety Management (PSM) .
The full recording of the session is available here. Slides are available for download below.
LOTO best practice Frank Deng, EHS Manager, TÜV Rheinland
上锁挂牌的最佳实践 (50mins 分钟) 邓柱明，EHS经理，德国莱茵
Local government regulations and best practices around hot work and confined space Shiwei Kong, EHS Head, Zhejiang Langhua Pharmaceutical
动火作业和受限空间作业：各级政府要求与企业最佳实践 (50mins 分钟) 孔识卫, EHS总监, 浙江朗华制药有限公司
The Practice of Dual-system in Pharmaceutical Enterprise Guoqiang Peng, EHS Manager Assistant, Hangzhou Zhongmei Huadong Pharmaceutical
双重预防体系（双体系）在制药企业中的运用 彭国强，EHS经理助理，杭州中美华东医药股份有限公司
Occupational exposure band and control technology in pharmaceutical industry Chengyin Guo, Deputy-director of EHS, Raybow Pharma
职业卫生分级管控及密闭技术在制药企业中的应用 郭成寅，EHS副总监，瑞博制药
Occupational health surveillance for pharmaceutical companies Minghua Gu, Deputy Physician, Shanghai Center for Disease Control and Prevention
制药企业职业健康体检 顾明华，副主任医师, 上海市疾病预防控制中心
The first session of the 2021 PSCI China supplier conferences took place virtually on 9 September and covered Introduction, Human Rights & Labor, Environment.
The full recording of the session is available here. Slides are available for download below.
Recent developments within PSCI Manjit Singh, PSCI Chair, Associate Director - Corporate Sustainability, Centrient
PSCI最新动态 Manjit Singh, PSCI主席，可持续发展副总监，灿盛制药
Audit Committee update: remote audit, audit sharing and supplier self-initiated audit Kelley Jiang, Head HSE TPRM Operational Excellence Global HSE, Novartis
审核委员会最新内容: 远程审计、共享审计报告与供应商自发PSCI 审核 江戎, 大中国区供应商健康安全环境风险管理主管, 诺华制药
Common findings in PSCI audits under Labor section Minnie Mai, Senior Technical Manager，TÜV Rheinland
审核劳工部分常见发现项 麦璐, 高级技术经理，德国莱茵
3060 carbon targets and latest government regulations Stone Huang, lawyer and certified safety engineer, Jin Mao Law Firm 3060双碳目标制定背景双碳目标制定背景及及最新相关法规政策探讨 黄启荣，律师/注册安全工程师, 金茂律师事务所
The issue of Pharmaceuticals in the Environment (PiE) is an increasing public concern. While manufacturing losses represent a small percentage of the overall API mass entering the environment, the PSCI is committed to addressing localized risks that may occur from pharmaceutical manufacturing operations. Many companies are requiring that their facilities – and their major suppliers – establish estimates for API mass loss and the resulting Predicted Environmental Concentration (PEC) in the water body that ultimately receives a facility’s wastewater discharge.
The PSCI-endorsed method for estimating API mass loss is to follow a mass balance approach where the API inputs, outputs, and losses are accounted for, allowing the mass entering wastewater to be estimated. The PSCI has developed a set of detailed guidance documents on how to approach the mass balance calculations, including this presentation which provides an overview of:
Our approach
Our methodology
Real-world examples
We were delighted to be joined on this webinar by:
Elizabeth Girardi-Schoen, Global Environmental Sustainability Leader at Pfizer
Jason Rushing, PE, Principal Engineer and PiE Subject Matter Expert at Arcadis
Nolan Chase, EIT, Consultant and PiE Specialist at Arcadis
The following document provides guidance on potential techniques, methodologies, and available data sources for the calculation of dilution factors. The correct approach to follow is dependent on specific aspects of the risk assessment to be conducted. The PSCI does not advocate a single correct approach or data source, but aims to provide information to help risk assessors design assessments suitable for their requirements.
The contents of this document has been kindly shared by the IAI PiE Task Force.
The following document provides guidance on potential techniques, methodologies, and available data sources for sampling and analysis of pharmaceutical industry wastewater. The correct approach to follow is dependent on specific aspects of the risk assessment to be conducted. The PSCI does not advocate a single correct approach or data source, but aims to provide information to help risk assessors design assessments suitable for their requirements.
The contents of this document has been kindly shared by the IAI PiE Task Force.
A clear process has been defined to ensure PSCI Audits are consistent and rigorous. A suite of tools are available to support and guide through the process. Follow the link to read more about:
In order to ensure quality and integrity, PSCI Audits are carried out either by qualified internal auditors working at PSCI member companies or by professional and independent third party audit firms.
PSCI has approved fifteen professional, independent third party audit firms to perform PSCI Audits.
Anti-bribery and corruption is one of the issues under the PSCI Principles. The PSCI has commissioned an external benchmark on anti-bribery and corruption (ABC) standards and trends in supply chain. This report has been created to help our member companies and suppliers strengthen the ABC risk management practice in their supply chain.
Background: Regulations around anti‐corruption have been tightened and stakeholder expectations have increased. PSCI wants to encourage and support members and suppliers to continually enhance their anti‐corruption program for compliance with the latest guidelines issued by different regulatory authorities around the globe. Organizations are expected to develop proactive, risk‐based compliance programs that are tailored to the specific risk profile and are reasonably designed to prevent them and their employees/agents/suppliers from engaging in bribery or corrupt acts.
We are very pleased to announce that the 2020 PSCI Annual Report was launched today, summarizing the progress and achievements we have made in advancing responsible supply chain practices within the pharmaceutical and healthcare industries over the past year.
Key developments in 2020 include:
Growth in membership, with over 45 member companies now committed to the initiative and having adopted the PSCI Principles
A new three-year strategy adopted to deliver our refreshed vision for excellence in safety, environmental, and social outcomes across the whole of the global pharmaceutical and healthcare supply chain
Pioneering remote audit standards aligned with the PSCI Principles, now available to members on our community platform The Link, alongside valuable resources, news, and training materials
Strengthened partnerships with our Indian and Chinese partners, recognizing the importance of those countries for the pharmaceutical supply chain
Unprecedented levels of supplier engagement through two large-scale virtual supplier conferences in China and India, reaching 700+ supplier delegates
Expansion of our Board to support the delivery of our ambitious strategy
Measured improvement in PSCI member companies’ contribution to and use of PSCI resources to address supply chain issues.
2020 was an extraordinary year, full of large-scale professional challenges for our industry and its supply chain, not to mention the personal challenges we all faced in our own lives. We are proud of the way the PSCI adjusted to these challenges, showing remarkable agility. It is clear that the importance of responsible supply chain practices cannot be overstated and we are pleased to be able to drive positive change across the industry through our collaborative efforts.
We welcome comments and encourage you to share this report with your networks.
Since 2016, a group of PSCI members have been working together to standardize their environmental data request to suppliers through a common set of questions, known as the PSCI Environmental Survey. The benefit is that suppliers should be receiving a common set of questions, but currently companies collect the data using different routes: some use an Excel file, and some a third-party platform.
The PSCI has now built the Environmental Survey into the PSCI platform for suppliers (called The Link). Each of the PSCI’s 50 members will now be able to use that platform to collect data from suppliers and we anticipate that many will do so. We hope that this will streamline and simplify your reporting of environmental and carbon emissions to your customers as one reply can now be shared with many customers.
Watch this webinar to learn more about the new platform and how to use it. You'll hear about:
Data captured by the survey
Technical aspects of the environmental survey
How to access the PSCI Link platform
Responding to requests to share your data from PSCI members
We were delighted to be joined by Alejandro Fiocco, Partner at Carnstone and Secretariat for the PSCI Environment Team.
The recording is available here. (Please refresh the page if you cannot play the video.)
The slides used during the webinar are available for download below.
Participants (including registrants who were unable to attend) are invited to share feedback about this webinar here.
Please also note that guidance about the Environmental survey is available here (the excel version is accessible here).
More great publicity for the PSCI with thanks to Dan Caldwell (Johnson & Johnson) and Steve Brooks (AMR Alliance) who recently recorded this CPhI podcast on pharmaceuticals in the environment (PiE) and anti-microbial resistance (AMR) and what the industry is doing to help address the challenge.
The PSCI has published a PEC:PNEC calculator tool for manufacturers to use to calculate how to meet safe levels of discharge for active pharmaceutical ingredients (APIs) from their sites.
This document is a step by step guidance on using the PSCI Environmental survey for suppliers on the PSCI platform. If you have any further questions, please do not hesitate to contact us.
This file contains the latest version of the PSCI Environmental survey for suppliers in Excel. The scoring for each question is detailed and questions are mapped across to the previous version.
Our April newsletter reflects recent activities including our support to the Musi River Revitalization Initiative, the publication of our Benchmarking Survey Insights Report, and our outreach campaign on the vital issue of anti-microbial resistance. It also highlights our upcoming plans and events, such as our Virtual Spring Meeting, and external developments relevant to pharmaceutical supply chains.
At the PSCI, we’re committed to doing everything in our power to limit that the spread and growth of two emerging threats – Pharmaceuticals in the Environment (PiE) and Anti-microbial Resistance (AMR). That’s why for World Health Day, we’re excited today to launch our new Position Statement, which provides a clear explanation of the critical role we play in helping our supplier partners improve their manufacturing practices. The statement has been written to highlight the relevance of the PiE issue along the supply chain, to articulate the PSCI's position on this high profile topic, and to help answer stakeholder inquiries. It includes an overview of all PSCI resources on PiE and AMR-related issues.
Supplier Self-initiated Audit Programme (SSIA) is a pilot programme led by PSCI Audit Committee to encourage suppliers to take a proactive, risk-based approach and self-initiate PSCI audits for their facilities.
With the pilot programme this year, the PSCI will pay for a new Supplier Self-initiated Audit of the supplier facility. The audit should be completed by a PSCI approved audit firm and shared with PSCI members on the Link. Any supplier to PSCI Member can apply to participate in SSIA.
This document for suppliers explains:
What is SSIA and the benefits
Who can participate and the requirements
How to conduct a SSIA
Members are welcome to share the brochure with suppliers you would like to see conducting a PSCI audit.
If you are interested in learning more about the programme, please contact Audit Committee Secretariat Blake Zheng for more information. Thank you.
In 2020, we invited the PSCI members to participate in our third formal Member Benchmarking Survey and we are pleased to present the results in this Insights Report. We have used the data collected over the years to share year-on-year trends, as well as provide a snapshot from 2020.
This report paints a picture of rising engagement and increasing focus on responsible procurement. We hope that you find it useful and insightful.
This document provides a guidance for auditors to classify Critical-Major-Minor findings under all five PSCI principles. It is for guidance only and each organization can have its own interpretations.
It is intended to be a living document, which will be reviewed and updated regularly by SAQ/Audit and Audit Guidance sub team.
This document was updated in June 2024 to align with the updated PSCI Principles. For each principle, the examples have been updated and reviewed by a working group formed from the SAQ/Audit and Audit Guidance sub-team. The updated document now also includes complete examples for the minor classification findings.
Stormwater management and Zero Liquid Discharge key points Daniel Rehm, HSE Advisor, External Manufacturing EMEA & API, Elanco
Introduction to PiE and AMR Dr Paul Barnett, Director, Environment Health & Safety, GlaxoSmithKline
Assessing Antibiotic Manufacturing Sites Capability in Controlling their Antibiotic Emissions Jonathan Stanway, Downstream & Pilot Plant Manager, Biotechnology & Environmental Shared Service, Pharma Supply Chain, GlaxoSmithKline
This session was facilitated by Maggie Zhang, Partner Manager at Carnstone.
The recording of the session is available here. Chinese users can download the recording here (password: PSCI).
Slides are available for download below.
The third session of the 2020 PSCI Auditor Training (Virtual) took place virtually on 2 December and covered below presentations.
Process safety risk – Identifying reactive hazards and powder processing hazard in pharmaceutical industry Kumarkrishna Bhattacharjee, Head HS&E Supplier Assurance and Risk India Region, Novartis
This session was facilitated by Lei Sun, Partner at Carnstone.
The recording of the session is available here. Chinese users can download the recording here (password: PSCI).
Slides are available for download below.
Corporate Responsibility with a Social Compliance Audits Dinesh Subhedar, Group Third Party Risk Management -Labour Rights (India and West Asia), Novartis (NBS Human Resources)
This session was facilitated by Maggie Zhang, Partner Manager at Carnstone.
The recording of the session is available here. Chinese users can download the recording here (password: PSCI).
The PSCI supports the efforts of the State of Telangana to reduce pollution of the Musi River, specifically in the immediate vicinity of the two drainage canals that flow into the world-heritage Hussain Sagar lake where a number of PSCI member suppliers’ operations are situated. Please find our full statement below.
Our winter newsletter reflects recent activities including our Annual General Meeting, supplier conferences, and webinars. It also highlights our upcoming plans, and external developments relevant to pharmaceutical supply chains.
This presentation on Implementing a comprehensive industrial hygiene program – panel presentation was delivered by:
此演讲由下列嘉宾分享如何实施一个全面的工业卫生方案 – 实用三步指南：
Chengyin Guo, General Manager Assistant (In charge of EHS), Raybow Pharma | 郭成寅, 总经理助理（负责 EHS）, 浙江瑞博制药有限公司
Zhibiao Ren, Astra Zeneca | Zhibiao Ren, 阿斯利康
Tracy Zhou, EHS&S External Supply, Johnson & Johnson | 周穗菁, EHS&S外部供应商经理，强生（中国）
This session was facilitated by Maggie Zhang, Partner Manager at Carnstone.
本环节由凯嵘管理咨询合伙人经理张缤莉主持。
The recording is available here (code:PSCI). The slides are available for download below.
会议视频请点击此 链接 获取 (提取码 PSCI)。会议PPT请在下方点击“DOWNLOAD”下载。
This presentation on Evolving Ethics Best Practices in the Pharmaceutical Industry: Introduction to PSCI Principles & Antibribery and Corruption was delivered by:
此演讲由下列嘉宾分享在制药行业中深化商业道德最佳实践：介绍PSCI准则、反贿赂和腐败：
This presentation on Evolving Ethics Best Practices in the Pharmaceutical Industry: Introduction to GDPR was delivered by:
此演讲由下列嘉宾分享在制药行业中深化商业道德最佳实践：在制药行业中深化商业道德最佳实践：介绍欧盟《通用数据保护条例》：
Tonny Hue, speaker title TBC, Deloitte | 薛梓源，网络安全领导合伙人，德勤中国
This session was facilitated by Maggie Zhang, Partner Manager at Carnstone.
本环节由凯嵘管理咨询合伙人经理张缤莉主持。
The recording is available here (code:PSCI). The slides are available for download below.
会议视频请点击此 链接 获取 (提取码 PSCI)。会议PPT请在下方点击“DOWNLOAD”下载。
A CONVERSATION ON FORCED LABOR AND MODERN SLAVERY | 强迫劳工和非自愿劳工
To respect the decision of the speaker, the recording and slides are not shared here.
为尊重嘉宾的意愿，此环节的视频和PPT不在此分享。
The second session of the 2020 PSCI China supplier conferences took place virtually on 24 September and covered Environment, Pharmaceuticals in the Environment/AMR.
The full recording of the session is available here (code:PSCI). Slides are available for download below.
Recordings and slides of individual presentations are also available as individual resources - please click on the relevant links below:
This presentation introducing Pharmaron’s work arrangement, prevention and control organization, and normalized control in the fight against COVID-19 was delivered by:
此演讲由下列嘉宾分享康龙化成的新冠疫情防控经验：
This presentation sharing the key points from China’s “Measures for Environmental Management Registration of New Chemical Substances” was delivered by:
此演讲由下列嘉宾介绍中国新化学物质环境管理办法的最新进展:
Lingzhen Dong, Asia Pacific Region -Product Stewardship Director, Johnson & Johnson | 董玲珍，亚太区EHS&S产品监管总监，强生（中国）
This session was facilitated by Maggie Zhang, Partner Manager at Carnstone.
本环节由凯嵘管理咨询合伙人经理张缤莉主持。
The recording is available here (code: PSCI). The slides are available for download below.
会议视频请点击此链接 获取 (提取码：PSCI) 获取会议视频。会议PPT请在下方点击“DOWNLOAD”下载。
The primary focus of this document is to provide a consistent guidance for pharmaceutical companies to calculate GHG emissions in their upstream and downstream value chains. It provides methodologies consistent with recommendations from the GHG Protocol for calculating emissions which are tailored for each different category.
This document was developed by the Pharmaceutical Environment Group (PEG) and its participating companies, who have kindly shared it with the PSCI for diffusion.
The second session of the 2020 PSCI India supplier conferences took place virtually on 24 September and covered Environment and Pharmaceuticals in the Environment/AMR.
The full recording of the session is available here. Slides are available for download below.
Recordings and slides of individual presentations are also available as individual resources - please click on the relevant links below:
The webinar explored best practice wastewater treatment methods for managing the release of APIs into the environment from pharmaceutical manufacturing sites. It was delivered by renowned experts and featured case studies on novel treatment technologies.
We were delighted to be joined by the following speakers:
Jeffrey Brenchley from Merck (MSD) (Senior Specialist, Global Safety & Environment), speaking about vacuum evaporation
Birgit Mertens from Johnson & Johnson (Senior Principal Environment Worldwide EHS&S), speaking about ozone as pretreatment
Jonathan Rhone from Axine Water Technologies Inc. (President and CEO), speaking about electrochemical oxidation
Participants are invited to share feedback about this webinar here.
The recording is available here. (Please refresh the page if you cannot play the video.)
The slides used during the webinar are available to download below.
Please also note that registration for the second session of our supplier conferences is open until 17 September. Topics covered will include climate change (GHG) & sustainable packaging ; sampling and analysing APIs in wastewater with case studies ; a case study on Controlling API Releases; environmental hazards of drugs and case analysis ; and mass balance calculations. To register, please click here for the China session and here for the India session.
Finally, we want your views! We're encouraging all suppliers to take this short survey to help the PSCI understand the impact it has on suppliers.
The agenda for China conference is updated on 10 September 2020. Please select the language that you prefer to use before downloading it.
下载会议议程前请先选择语言：英文、简体中文。
A PSCI Sub-Team is seeking a consultant to undertake approximately 10 days’ research looking at standards, trends and company practices to prevent bribery and corruption in supply chains. The work will be carried out in August and September, and would suit a small consultancy or single individual with the appropriate expertise. All of the details are in the attached RFP document. Proposals are due by 31st July.
Proposals are to be sent to the PSCI email address: info@PSCInitiative.org.
The PSCI has recently published its Summer newsletter, reflecting on achievements in the first half of 2020 and looking ahead at a busy programme of exciting events and projects for the rest of the year.
Download the newsletter below to read about our efforts to digitalize our offer to suppliers, our position on important issues such as PiE/AMR, and the partnerships we’re forming with Indian and Chinese organizations. You’ll also find updates on PSCI audit findings from the past three years, our take on emerging issues in supply chains – and more!
This document is for members to use when promoting the PSCI. This version is the A4 document for in-house printing, however US paper size and commercial printing documents are available upon request.
The Chinese (Simplified) version of the pamphlet was published in April 2019.
To request alternative versions, please contact the PSCI Secretariat.
This webinar first aired on 27 May and explained the updates and changes to the Audit Guidance document. We were delighted to be joined by the following speaker:
Birgit Skuballa, from Bayer
The webinar attracted over 100 registrants and around 90 people joined on the day.
Participants are invited to share feedback about this webinar here.
We are very pleased to announce that the PSCI 2019 Annual Report is now available, summarising our collective efforts towards responsible supply chains during 2019.
Key developments in 2019 include:
Growth in membership, with today over 40 member companies.
Hundreds of audits completed to PSCI standards now available to members on our new community platform The Link, alongside valuable resources, news, and training materials.
Unprecedented levels of supplier engagement through two large-scale supplier conferences in Hangzhou (China) and Hyderabad (India), reaching 400 supplier delegates.
New Partnerships Committee focused on intensifying our relationship with our Indian and Chinese partners.
Expansion of our expert advisory panel, now composed of eight external experts who challenge and advise the Board.
Measured improvement in PSCI member companies’ public reporting of supply chain data and commitment to PSCI’s Principles.
In 2020, much of business will be operating in a changed environment. It remains to be seen exactly how this will affect the industry and our supply chain practices. Our focus on efficient sharing of audits and virtually-enabled capability building activities is even more important in the wake of Covid-19. Whatever changes arise from this crisis, responsible supply chain practices will be central to our industry’s response.
We welcome comments and encourage you to share this report with your networks.
We are proud to launch our online platform specially-developed for the supplier community. The Link is a place for suppliers to connect, engage and to advance their responsible supply chain practices. The attached announcement provides an overview of the platform and details on how to get started.
MS Word version
PSCI Self Assessment Questionnaire and Audit Report Template for Core Suppliers, External Manufacturers, Component and Material Suppliers
More Info…
Update History
Version 5, February 2019
Chinese translation added July 2019.
Japanese translation added April 2020. Remote audit options added November 2020.
Since 20 April 2022, the Word versions of the templates (Full, Abbreviated, CAPR) have been removed completely following a consultation process and notice period. Access to these is only be possible in exceptional circumstances and by contacting the PSCI Secretariat. Please use the Excel versions: Full, Abbreviated, CAPR
On behalf of the Board and Communications Committee and with thanks to the Pharmaceuticals in the Environment (PiE)/ Anti-Microbial Resistance (AMR) sub-team for their expert input, we are sharing the recently adopted PSCI Position Statement on PiE & AMR. It has been written to highlight the relevance of the PiE issue along the supply chain, to articulate PSCI's position on this high profile topic, and to help answer stakeholder inquiries. It includes an overview of all PSCI resources on PiE and AMR-related issues.
This document can be used by suppliers to document agreed corrective actions, the type of finding(e.g. Critical-Other, Critical-Major/Minor), the time period for completion, the type of verification (e.g. desk top review of documents or follow up visit), the responsible individual at the supplier for the individual corrective actions, details on the implemented corrective action and a status assignment (open/closed).
Since 20 April 2022, the Word versions of the templates (Full, Abbreviated, CAPR) have been removed completely following a consultation process and notice period. Access to these is only be possible in exceptional circumstances and by contacting the PSCI Secretariat. Please use the Excel versions: Full, Abbreviated, CAPR
This document can be used by suppliers to document agreed corrective actions, the type of finding(e.g. Critical/Major/Minor), the time period for completion, the type of verification (e.g. desk top review of documents or follow up visit), the responsible individual at the supplier for the individual corrective actions, details on the implemented corrective action and a status assignment (open/closed).
Content version v4.0, March 2020 Content version v5.0, December 2021
Our latest newsletter, accessible at the link below, reflects recent activities including our Annual General Meeting, supplier conferences and webinars. It also highlights our upcoming plans, and external developments relevant to pharmaceutical supply chains.
The 2023 revision of the PSCI Principles (PSCI Principles v3.0) was approved by the membership on Tuesday 23rd May 2023, at the Spring Meeting in Paris (France), and became effective immediately.
The PSCI Principles for Responsible Supply Chain Management are foundational, setting members' expectations of suppliers, and form the base for all PSCI's tools and materials.
These Principles set the standard for governance and management systems, ethics, human rights, health and safety, and environmental business practices.
The Principles are adopted by all PSCI members and may be voluntarily supported by any business in the pharmaceutical and healthcare industry.
This webinar initially aired on Thursday 24th October 2019.
In this webinar we explored what is meant by modern slavery, where it is found in the world and how it can be addressed in the pharma supply chain.
Our speaker covered the evolving legislative landscape for modern slavery as it relates to pharma, how to identify risks and case study examples of how to address them.
We were delighted to be joined by the following speaker:
This webinar initially aired on Thursday 24th October 2019.
In this webinar we explored what is meant by modern slavery, where it is found in the world and how it can be addressed in the pharma supply chain.
Our speaker covered the evolving legislative landscape for modern slavery as it relates to pharma, how to identify risks and case study examples of how to address them.
We were delighted to be joined by the following speaker:
Graphic of PSCI SDG mapping. We recently mapped PSCI Principles and activities against the UN's Sustainable Development Goals. It was an interesting exercise, revealing where our missions align. We plan to build on this by applying the SDG framework in ongoing and future workstreams.
In this webinar we will be looking at the impact of pharmaceutical manufacturing on antimicrobial resistance, as well as demonstrating PSCI's PEC:PNEC calculator tool.
Our speakers will be covering the issues associated with antimicrobial drugs in wastewater, targets for environmental risk assessment of antimicrobial drugs, and how to assess the risk of antimicrobial drugs in wastewater.
We are delighted to be joined by the following speakers:
Daniel Caldwell, Global Director, Environmental and Occupational Toxicology at Johnson & Johnson;
In this webinar we will be looking at the impact of pharmaceutical manufacturing on antimicrobial resistance, as well as demonstrating PSCI's PEC:PNEC calculator tool.
Our speakers will be covering the issues associated with antimicrobial drugs in wastewater, targets for environmental risk assessment of antimicrobial drugs, and how to assess the risk of antimicrobial drugs in wastewater.
We are delighted to be joined by the following speakers:
Daniel Caldwell, Global Director, Environmental and Occupational Toxicology at Johnson & Johnson;
This version has been updated. Please refer to the newer version.
This Excel spreadsheet tool provides instructions and guidance on how to assist pharmaceutical manufacturers in calculating how to meet predicted no effect concentration values (PNECs) for active pharmaceutical ingredients (APIs) discharged in wastewater from manufacturing operations.
This webinar was initially aired on 27th June 2019
The webinar will give an overview of the questions relating to emergency preparedness & response in the PSCI audit questionnaire and explain the PSCI's expectations.
The webinar will focus on how to prepare a good site emergency response plan that covers the minimum requirements. You will also hear about the basic elements that should be considered when performing an impact assessment of neighboring industries on your site & vice versa.
We are delighted to be joined by the following speaker:
Aaron Duff, Director of EHS&S at Johnson & Johnson
This webinar was initially aired on 27th June 2019
The webinar will give an overview of the questions relating to emergency preparedness & response in the PSCI audit questionnaire and explain the PSCI's expectations.
The webinar will focus on how to prepare a good site emergency response plan that covers the minimum requirements. You will also hear about the basic elements that should be considered when performing an impact assessment of neighboring industries on your site & vice versa.
We are delighted to be joined by the following speaker:
Aaron Duff, Director of EHS&S at Johnson & Johnson
Over the past year the PSCI has gone from strength to strength, growing both in numbers and influence. In line with our growing reach, we have produced a short video explaining the work of the Initiative. We hope that members and stakeholders share this with their networks, and that it helps those unfamiliar with our work understand what we do.
The film is now also available with subtitles in the following languages, click on the links to view the videos on Vimeo:
"2018 has seen PSCI gain more members, reach more suppliers, perform more audits and host more events than ever before. The growth in our membership is a huge achievement but it is the growth in our impact that I am most proud of.
In the pages of this report you will read about our other achievements this year: holding members accountable, setting up a Board Advisory Panel, sharing data on suppliers’ carbon emissions, and a new visual brand identity and logo. Perhaps the most important pages are the ones that show our impact; the suppliers trained, the audits completed and followed up, the downloads of advisory documents from our technical library."
Dr Birgit Skuballa, Bayer (Chair of the PSCI during 2018)
WORD VERSION
Abbreviated PSCI Self Assessment Questionnaire & Audit Report Template for Service Providers & General Manufacturers
Version 5, February 2019 Version 6, remote audit options added, October 2020
Since 20 April 2022, the Word versions of the templates (Full, Abbreviated, CAPR) have been removed completely following a consultation process and notice period. Access to these is only be possible in exceptional circumstances and by contacting the PSCI Secretariat. Please use the Excel versions: Full, Abbreviated, CAPR
This PSCI Audit Sharing Platform User Guide explains how to use the Audit Sharing Platform for members. The platform underpins the PSCI Audit Sharing Program. It is the platform for sharing audits with the PSCI membership.
Please refer to the PSCI Shared Audit Program Guidance for more information about the PSCI Audit Sharing Program.
This document is designed to be used by PSCI members, audit contractors and suppliers. It provides a detailed overview of the audit process and corresponding roles and responsibilities at each stage of the process.
Version 7, December 2021
Updated to reflect changes to Supplier Categorisation, classification of findings only as critical/major/minor (and added link to finding classification guidance document) and remove reference to the now withdrawn OHSAS 18001.
This is recording of the PSCI sponsored webinar on evaluating supplier ethics and compliance practices and programs which took place on 25th July 2018.
This is the slide deck from the PSCI sponsored webinar on evaluating supplier ethics and compliance practices and programs which took place on 25th July 2018.
This is the slide deck from the PSCI sponsored webinar on how to manage APIs in manufacturing effluent (Part 4) which took place on 10th July 2018.
The webinar gave a brief refresher on Pharmaceuticals in the Environment (PiE), Anti-Microbial Resistance (AMR) and Predicted No-Effect Concentration (PNEC) first principles, and introduced a PSCI resource page where PNECs can be found. It also included step-by-step guidance on how to locate PNECs and use them.
This is recording of the PSCI sponsored webinar on how to manage APIs in manufacturing effluent (Part 4) which took place on 10th July 2018.
The webinar gave a brief refresher on Pharmaceuticals in the Environment (PiE), Anti-Microbial Resistance (AMR) and Predicted No-Effect Concentration (PNEC) first principles, and introduced a PSCI resource page where PNECs can be found. It also included step-by-step guidance on how to locate PNECs and use them.
The following are useful resources for obtaining PNEC values.
AMR Industry Alliance Antibiotic Discharge Targets - List of Predicted No-Effect Concentrations (PNECs).
The PNEC table contains two values, PNEC‐Environment (PNEC‐ENV) values based on eco-toxicology and PNEC‐Minimum Inhibitory Concentration (PNEC‐MIC) values intended to be protective of resistance promotion.
The AMR Industry Alliance recommendation is that companies target the lower of these two values (when available) for assessing manufacturing site discharges under a risk‐based framework.
Slides from the PSCI Audit Programme Webinar, Oct 2017
The webinar explained the supplier self-initiated audit model and launched the new Excel based audit templates.
This Excel template is designed to help PSCI members, suppliers and audit firms check auditors against the PSCI's requirements, to ensure that they have the expertise needed to conduct PSCI audits. It is also used by new audit firms in their application process to demonstrate their capacity.
This evaluation tool is also known as PSCI Auditor Information Template (HSE & Social Auditors).
This is the slide deck for the PSCI sponsored webinar on how to manage APIs in manufacturing effluent (Part 3) which took place on 25th October 2016. The webinar looked at advanced technologies to reduce API loss with guest speakers from the Temple University WET Centre and AECOM.
This is recording of the PSCI sponsored webinar on how to manage APIs in manufacturing effluent (Part 2) which took place on 15th June 2016. The webinar provided step-by-step guidance on this ‘spotlight’ issue for our industry and covered the following topics:
estimating actual API losses from the manufacturing process (PEC)
establishing the acceptable discharge concentration (PNEC)
making low capital investment housekeeping steps to reduce the loss of APIs
This is the slide deck for the PSCI sponsored webinar on how to manage APIs in manufacturing effluent (Part 2) which took place on 15th June 2016. The webinar provided step-by-step guidance on this ‘spotlight’ issue for our industry and covered the following topics:
estimating actual API losses from the manufacturing process (PEC)
establishing the acceptable discharge concentration (PNEC)
making low capital investment housekeeping steps to reduce the loss of APIs
This is the slide deck for the PSCI sponsored webinar on how to manage APIs in manufacturing effluent which took place on 27th January 2016. The webinar provided step-by-step guidance on this ‘spotlight’ issue for our industry and covered the following topics:
Why is managing active pharmaceutical ingredients (API) in manufacturing effluent important?
What is the industry doing to improve public perceptions?
Understanding where you stand at the moment through the maturity ladder concept.
Establishing and calculating API discharge concentration called the Predicted-No-Effect-Concentration (PNEC).
Simple steps to reducing API process losses to waste water and what to do when the PNEC is exceeded.
This is a recording of the PSCI sponsored webinar on how to manage APIs in manufacturing effluent which took place on 27th January 2016. The webinar provided step-by-step guidance on this ‘spotlight’ issue for our industry and covered the following topics:
Why is managing active pharmaceutical ingredients (API) in manufacturing effluent important?
What is the industry doing to improve public perceptions?
Understanding where you stand at the moment through the maturity ladder concept.
Establishing and calculating API discharge concentration called the Predicted-No-Effect-Concentration (PNEC).
Simple steps to reducing API process losses to waste water and what to do when the PNEC is exceeded.
This PSCI Audit Sharing Platform User Guide explains how to use the Audit Sharing Platform for suppliers. The platform underpins the PSCI Audit Sharing Program. It is the platform for sharing audits with the PSCI membership.
Please refer to the PSCI Shared Audit Program Guidance for more information about the PSCI Audit Sharing Program.
Abstract: This Caldwell et al. study describes guidance intended to assist pharmaceutical manufacturers in assessing, mitigating, and managing the potential environmental impacts of active pharmaceutical ingredients (APIs) in wastewater from manufacturing operations, including those from external suppliers.
