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 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.
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.
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
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)
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.
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 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.
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.
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.
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 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 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.
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.
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 set the standard for human rights, ethics, labor, health and safety, environment and related management systems.The Principles may be voluntarily supported by any business in the pharmaceutical industry.
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.
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 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.
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.
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.
