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.
In 2022, the PSCI and Sustainable Markets Initiative Health Systems Task Force Members worked together to develop a set of joint climate & sustainability targets for their suppliers. PSCI was engaged as part of the effort and will be including the standards into the existing maturity model.
The aim of this webinar is to:
• Provide an overview of the work of the Task Force and PSCI to support decarbonisation of health care supply chains
• Announce the Task Force’s joint supplier sustainability targets and discuss implications for suppliers
The SMI Health Systems Task Force was launched at the 26th United Nations Climate Change Conference (COP26) with the central aim of accelerating the delivery of net zero, patient-centric healthcare systems that improve individual, societal, and planetary health. The public-private partnership brings together CEOs and leaders from AstraZeneca, GSK, Merck, Novo Nordisk, Roche, Samsung Biologics, Sanofi, the Karolinska Institutet, National Health Service England, the Sustainable Healthcare Coalition, UNICEF, the University of Pavia, and the World Health Organization (WHO).
Task Force members aligned on a set of joint targets and engaged with suppliers and with PSCI during the process. The key dimensions of the targets were published at COP27 as part of the SMI Health Systems Task Force whitepaper on Decarbonising 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
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
Full version template for Core Suppliers, External Manufacturers, Component and Material Suppliers are also available and come in multiple languages: Excel version.
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
Abbreviated version template for Service Providers & General Manufacturers are also available: Excel version.
The SAQ is currently available in the following languages:
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 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.
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.
