Access our full library of resources, register for events and webinars and share audits and other assessments
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.
This is an explainer video on the PSCI Governance Structure with English subtitles.
This is a short video explaining the Governance Structure of the PSCI.
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:
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.
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:
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.
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.
This document was updated in June 2024 to align with the updated PSCI Principles. For each principle, the examples have been updated and reviewed by a working group formed from the SAQ/Audit and Audit Guidance sub-team. The updated document now also includes complete examples for the minor classification findings.
The second session of the 2020 PSCI Auditor Training (Virtual) took place virtually on 25 November and covered below presentations.
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 fourth session of the 2020 PSCI Auditor Training (Virtual) took place virtually on 3 December and covered below presentations.
This session was facilitated by Lei Sun, Partner 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 third session of the 2020 PSCI Auditor Training (Virtual) took place virtually on 2 December and covered below presentations.
This session was facilitated by Lei Sun, Partner 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 first session of the 2020 PSCI Auditor Training (Virtual) took place virtually on 24 November and covered below presentations.
PSCI Audit Update 2020
Birgit Isabelle Skuballa, Head HSE Audit & Supplier Management, Bayer
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.
For those interested in becoming PSCI approved audit partners, this document covers:
Last updated December 2020
The PSCI supports the efforts of the State of Telangana to reduce pollution of the Musi River, specifically in the immediate vicinity of the two drainage canals that flow into the world-heritage Hussain Sagar lake where a number of PSCI member suppliers’ operations are situated. Please find our full statement below.
Our winter newsletter 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 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 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:
The webinar attracted over 100 registrants and around 90 people joined on the day.
Participants are invited to share feedback about this webinar here.
The recording is available here.
The slides used during the webinar are available to download below.
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.
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.
Presentation Pack from the 2019 PSCI Auditor Training, 26-27 September in Hangzhou, China.
You can also find the recap video here.
Please find the links below to the training slides of both days.
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.
Introduction presentation for PSCI audit opening meeting.
Version 1 - 07/02/2017
Version 2 - 01/08/2019
Version 3 - 15/04/2020
Version 4 - 31/08/2020
Version 5 - 31/08/2021
Version 6 - 20/12/2021
This presentation summarises who we are as PSCI and includes an overview of:
Latest version: January 2024
This document gives a summary of the PSCI Audit Program and process and answers frequently asked questions including:
Last updated December 2021
Presentation Pack from the 2018 PSCI Auditor Training, 4 - 5 December in Vienna, Austria
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 PSCI webinar is a training video for auditors. This was recorded in September 2018.
The slides shown in this webinar can be found here.
This is a short summary of the new strategy, and the process taken to achieve it.
Presentation Pack from the 2017 PSCI Auditor Training, 20 - 22 November, in Shanghai, China.
Presentation Pack from the 2017 PSCI Auditor Training, 20 - 22 November, in Shanghai, China.
Presentation Pack from the 2017 PSCI Auditor Training, 20 - 22 November, in Shanghai, China.
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).
Last updated March 2021.
Presentation booklet from the 2017 PSCI Auditor Training, 28 Feb - 1 March, in Hyderabad, India
The PSCI Maturity App provides an interactive experience of the PSCI Maturity Models. Available on Android and iOS.