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as critical/major/minor (and added link to finding classification guidance document) and remove reference to the now withdrawn OHSAS 18001.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 14 November 2018
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 resource was published on 28 October 2018
These slides were shown as part of a Auditor Training webinar, which can be found here.
This training was delivered in September 2018.
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 10 October 2018
This is a training tool for PSCI members and their suppliers on the PSCI Principles. The course will take approximately 30 minutes to complete.
Registration instructions:
- If you are using the tool for the first time, please follow the 'click here' link on the login page to register yourself. Please fill in your First name, Last name, Login ID (of your own choice) and Email address on the self-registration form and submit. The Login ID and Password will be sent to your email address. You may then use the ID and password to log in the platform and take the course.
If you cannot access the tool or have any questions, please email the Secretariat team .
This resource was published on 21 September 2018
Day 2 presentation pack from the 2018 Supplier Conference in Shanghai, China.
This resource was published on 21 September 2018
Day 1 presentation pack from the 2018 Supplier Conference in Shanghai, China.
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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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Pharmaceuticals In The Environment
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Anti-Microbial Resistance
This resource was published on 20 August 2018
PSCI Anti-trust Statement in English and Chinese
This resource was published on 1 August 2018
This is the agenda for 2018 PSCI India Supplier Conference.
This resource was published on 26 July 2018
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 resource was published on 26 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 resource was published on 26 July 2018
This is the agenda for 2018 PSCI China Supplier Conference.
This resource was published on 11 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.
The webinar recording is available here.
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Environment
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Pharmaceuticals In The Environment
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Anti-Microbial Resistance
This resource was published on 11 July 2018
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 webinar slide deck is available here.
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Environment
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Pharmaceuticals In The Environment
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Anti-Microbial Resistance
This resource was published on 11 July 2018
This document defines the PSCI member audit sharing target.
Approved by the PSCI Board in May 2018.
Applicable from January 2019.
Lightly refreshed in March 2021 to include remote audit counting and provide clearer definition of terms used.
Updated the web link to Approved Audit Firms in July 2021.
This resource was published on 11 June 2018
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Pharmaceuticals In The Environment
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Anti-Microbial Resistance
This resource was published on 19 March 2018
Inside the report, you will find highlights and achievements from 2017, a busy and important year for PSCI, and our plans for 2018.
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 30 November 2017
This document outlines the criteria, responsibilities and benefits of the two PSCI membership types - Full and Associate
New version added: July 2018
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 12 September 2017
The PSCI Membership Agreement has been updated to include Clause 6(d) on personal data protection. It sets out clearly the legal basis on which we collect and use member personal data under the General Data Protection Regulation.
This resource was published on 12 September 2017
PSCI Articles of Incorporation
This resource was published on 12 September 2017
Bylaws of the Pharmaceutical Supply Chain Initiative. Last updated in June 2020.
This resource was published on 19 May 2017
2017 India Conference Presentation Pack Day 2
This resource was published on 19 May 2017
2017 India Conference Presentation Pack Early Bird Dekra
Chemical Hazard Assessment & Runaway Reactions
This resource was published on 19 May 2017
2017 India Conference Presentation Pack Early Bird PSCI Basics
This resource was published on 19 May 2017
2017 India Conference Presentation Pack Day 3
This resource was published on 19 May 2017
2017 India Conference Presentation Pack Day 1
This resource was published on 30 March 2017
Agenda for 2017 Supplier Conference in Hyderabad, India
This resource was published on 20 March 2017
Green Chemistry Pharma Week Photo Report February 2017
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 30 November 2016
Day 2 presentation pack from the 2016 Supplier Conference held in Shanghai.
This resource was published on 30 November 2016
Day 1 presentation pack from the 2016 Supplier Conference held in Shanghai.
This resource was published on 26 October 2016
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.
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Environment
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Pharmaceuticals In The Environment
This resource was published on 20 June 2016
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
The webinar's slide-deck is available here.
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Environment
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Pharmaceuticals In The Environment
This resource was published on 20 June 2016
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
The webinar recording is available here.
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Environment
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Pharmaceuticals In The Environment
This resource was published on 24 February 2016
This social media guide aims to raise the profile of PSCI members on LinkedIn and Twitter, the 2 social networks which are part of our marketing communications strategy.
It outlines the key actions that members can take to boost the profile of PSCI on LinkedIn and Twitter.
This resource was published on 3 February 2016
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.
- How to advance your program to the next level.
The webinar recording is available here.
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Environment
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Pharmaceuticals In The Environment
This resource was published on 3 February 2016
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.
- How to advance your program to the next level.
The webinar slide-deck is available here.
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Environment
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Pharmaceuticals In The Environment
This resource was published on 1 February 2016
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.
This resource was published on 20 January 2016
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.
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Environment
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Pharmaceuticals In The Environment
This resource was published on 6 January 2016
This document explains the PSCI membership fees structure.
New version added: November 2021
This resource was published on 14 October 2015
Full presentation pack from the 2015 Supplier Conference held in Mumbai, India.
This resource was published on 9 September 2015
2015 India Supplier Conference Brochure
This resource was published on 3 August 2015
Pre-Audit Document Request List
