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.
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
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:
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:
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 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 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.
