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 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.
