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.
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 8, November 2025
Updated to align with the updated PSCI Principles and Strategy, inclusion of the digital Data Sharing via the PSCI Audit Platform, updated audit uploading requirements for full members, introduced online SAQ and removed reference of word version template, referenced the Audit Checklist as a separate resource in Chapter 10 and added section on Managing Audit Related Issues in the appendix.
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.
