This resource was published on 10 February 2021
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.
This resource was published on 1 February 2021
The second session of the 2020 PSCI Auditor Training (Virtual) took place virtually on 25 November and covered below presentations.
- Environmental protection
Manjit Singh, Associate Director- Corporate Sustainability, Centrient Pharmaceuticals
- 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.
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Environment
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Audit Program
This resource was published on 1 February 2021
The fourth session of the 2020 PSCI Auditor Training (Virtual) took place virtually on 3 December and covered below presentations.
- Plant General Safety
Pratap Padalkar, Associate Director, Chemical Development & Manufacturing, Gilead
- Occupational health and industrial hygiene in plants
Pratap Padalkar, Associate Director, Chemical Development & Manufacturing, Gilead
- High risk work and red flags for dangerous working
Roberta Haski, HSE Leader, External Manufacturing & Commercial, Asia Pacific, Japan, ANZ
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.
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Safety - High Risk Areas
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Audit Program
This resource was published on 1 February 2021
The third session of the 2020 PSCI Auditor Training (Virtual) took place virtually on 2 December and covered below presentations.
- Process safety risk – Identifying reactive hazards and powder processing hazard in pharmaceutical industry
Kumarkrishna Bhattacharjee, Head HS&E Supplier Assurance and Risk India Region, Novartis
- Emergency preparedness & response
Daniel Rehm, HSE Advisor, External Manufacturing EMEA & API, Elanco
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.
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Process Safety
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Emergency Preparedness & Response
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Audit Program
This resource was published on 1 February 2021
The first session of the 2020 PSCI Auditor Training (Virtual) took place virtually on 24 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.
This resource was published on 28 January 2021
For those interested in becoming PSCI approved audit partners, this document covers:
- Document checklist
- Application process
- Re-initiating application if not approved for the first time
Last updated December 2020
This resource was published on 22 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.
This resource was published on 18 December 2020
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.
This resource was published on 2 July 2020
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 resource was published on 8 June 2020
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.
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 resource was published on 19 April 2020
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
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Ethics
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Human Rights & Labor
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Health & Safety
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Environment
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Management Systems
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Audit Program
This resource was published on 25 March 2020
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 resource was published on 24 March 2020
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
This resource was published on 17 December 2019
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.
This resource was published on 12 December 2019
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.
This resource was published on 26 November 2019
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.
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Ethics
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Human Rights & Labor
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Health & Safety
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Environment
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Management Systems
This resource was published on 1 August 2019
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 resource was published on 5 July 2019
This presentation summarises who we are as PSCI and includes an overview of:
- PSCI members
- PSCI leaders
- PSCI Principles
- Strategy 2024 - 2026
- Strategic Pillars | Audit | Capability | Projects
- Topic and Regional Teams
Latest version: January 2024
This resource was published on 4 July 2019
This document gives a summary of the PSCI Audit Program and process and answers frequently asked questions including:
- Why do we audit?
- What are "Shared" Audits?
- Who benefits from Shared Audits?
- Initiating a PSCI Audit
- What happens in a PSCI Audit?
- Who carries out the audit?
Last updated December 2021
This resource was published on 17 May 2019
Presentation Pack from the 2018 PSCI Auditor Training, 4 - 5 December in Vienna, Austria
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Pharmaceuticals In The Environment
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Anti-Microbial Resistance
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Audit Program
This resource was published on 7 February 2019
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
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Ethics
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Human Rights & Labor
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Health & Safety
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Environment
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Management Systems
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Audit Program
This resource was published on 14 November 2018
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 resource was published on 26 October 2018
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 resource was published on 17 January 2018
This is a short summary of the new strategy, and the process taken to achieve it.
This resource was published on 22 November 2017
Presentation Pack from the 2017 PSCI Auditor Training, 20 - 22 November, in Shanghai, China.
This resource was published on 22 November 2017
Presentation Pack from the 2017 PSCI Auditor Training, 20 - 22 November, in Shanghai, China.
This resource was published on 22 November 2017
Presentation Pack from the 2017 PSCI Auditor Training, 20 - 22 November, in Shanghai, China.
This resource was published on 5 October 2017
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 resource was published on 26 September 2017
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.
This resource was published on 20 March 2017
Presentation booklet from the 2017 PSCI Auditor Training, 28 Feb - 1 March, in Hyderabad, India
This resource was published on 14 February 2017
PSCI Auditor Training presentation deck from 2015
This resource was published on 3 August 2015
Pre-Audit Document Request List
