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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.

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This resource was published on 14 November 2018
Audit Guidance For PSCI Audits

Audit Guidance For PSCI Audits

Document

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as critical/major/minor (and added link to finding classification guidance document) and remove reference to the now withdrawn OHSAS 18001.

  • Audit Program
This resource was published on 14 November 2018

Audit Sharing Platform Member User Guide

Document

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.

  • Audit Program
This resource was published on 28 October 2018

Introductory Training For Auditors - Slides

Slides

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

Introductory Training For Auditors

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.

  • Audit Program
This resource was published on 10 October 2018
PSCI Principles E-Learning Tool

PSCI Principles E-Learning Tool

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

Supplier Conference 2018 (China) - Day 2 - Presentation Pack

Document

Day 2 presentation pack from the 2018 Supplier Conference in Shanghai, China.

This resource was published on 21 September 2018

Supplier Conference 2018 (China) - Day 1 - Presentation Pack

Document

Day 1 presentation pack from the 2018 Supplier Conference in Shanghai, China.

  • Ethics
  • Human Rights & Labor
  • Health & Safety
  • Environment
  • Management Systems
  • Pharmaceuticals In The Environment
  • Anti-Microbial Resistance
This resource was published on 20 August 2018

PSCI Anti-Trust Statement EN CN

Document

PSCI Anti-trust Statement in English and Chinese

This resource was published on 1 August 2018

Supplier Conference 2018 (India) - Agenda

Agenda

This is the agenda for 2018 PSCI India Supplier Conference.

This resource was published on 26 July 2018

Evaluating Supplier Ethics & Compliance Practices & Programs Webinar 25th July 2018 - Recording

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

Evaluating Supplier Ethics & Compliance Practices & Programs Webinar 25th July 2018 - Slides

Slides

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

Supplier Conference 2018 (China) - Agenda

Agenda

This is the agenda for 2018 PSCI China Supplier Conference.

Select your preferred language from the options below
This resource was published on 11 July 2018

Managing APIs In Manufacturing Effluent Webinar Part 4 - 10th July 2018 - Slides

Document

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.

  • Environment
  • Pharmaceuticals In The Environment
  • Anti-Microbial Resistance
This resource was published on 11 July 2018

Managing APIs In Manufacturing Effluent Webinar Part 4 - 10th July 2018 - Recording

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.

  • Environment
  • Pharmaceuticals In The Environment
  • Anti-Microbial Resistance
This resource was published on 11 July 2018

PSCI Member Audit Sharing Target

Document

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.

  • Audit Program
This resource was published on 11 June 2018

Predicted-No-Effect-Concentration (PNEC) Resource Links

The following are useful resources for obtaining PNEC values.

  1. 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.
  2. Temple WET Center PNEC database where you will find PNEC values for APIs other than antibiotics.
  • Pharmaceuticals In The Environment
  • Anti-Microbial Resistance
This resource was published on 19 March 2018
PSCI Inaugural Annual Report 2017 / 2018

PSCI Inaugural Annual Report 2017 / 2018

Document

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

Strategy 2018-2020

Document

This is a short summary of the new strategy, and the process taken to achieve it.

This resource was published on 30 November 2017

PSCI Membership Types

Organisational Information

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

Auditor Training 2017 (China) - Day 1

Training

Presentation Pack from the 2017 PSCI Auditor Training, 20 - 22 November, in Shanghai, China.

  • Audit Program
This resource was published on 22 November 2017

Auditor Training 2017 (China) - Day 2

Training

Presentation Pack from the 2017 PSCI Auditor Training, 20 - 22 November, in Shanghai, China.

  • Audit Program
This resource was published on 22 November 2017

Auditor Training 2017 (China) - Day 3

Training

Presentation Pack from the 2017 PSCI Auditor Training, 20 - 22 November, in Shanghai, China.

  • Audit Program
This resource was published on 5 October 2017

Audit Programme Webinar - 4th October 2017 - Slides

Slides

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

Auditor Evaluation Tool

Document

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.

  • Audit Program
This resource was published on 12 September 2017

PSCI Membership Agreement

Organisational Information

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

Organisational Information

PSCI Articles of Incorporation

This resource was published on 12 September 2017

PSCI Bylaws

Organisational Information

Bylaws of the Pharmaceutical Supply Chain Initiative. Last updated in June 2020.

This resource was published on 19 May 2017

Supplier Conference 2017 (India) - Day 2 - Presentation Pack

Slides

2017 India Conference Presentation Pack Day 2

This resource was published on 19 May 2017

Supplier Conference 2017 (India) - Early Bird Dekra Presentation Pack

Slides

2017 India Conference Presentation Pack Early Bird Dekra
Chemical Hazard Assessment & Runaway Reactions

This resource was published on 19 May 2017

Supplier Conference 2017 (India) - Early Bird PSCI Basics Presentation Pack

Slides

2017 India Conference Presentation Pack Early Bird PSCI Basics

This resource was published on 19 May 2017

Supplier Conference 2017 (India) - Day 3 - Presentation Pack

Slides

2017 India Conference Presentation Pack Day 3

This resource was published on 19 May 2017

Supplier Conference 2017 (India) - Day 1 - Presentation Pack

Slides

2017 India Conference Presentation Pack Day 1

This resource was published on 30 March 2017

Supplier Conference 2017 (India) - Agenda

Agenda

Agenda for 2017 Supplier Conference in Hyderabad, India

This resource was published on 20 March 2017

Green Chemistry Pharma Week Photo Report

Document

Green Chemistry Pharma Week Photo Report February 2017

This resource was published on 20 March 2017

Auditor Training 2017 (India)

Training

Presentation booklet from the 2017 PSCI Auditor Training, 28 Feb - 1 March, in Hyderabad, India

  • Audit Program
This resource was published on 14 February 2017

Auditor Training 2015

Training

PSCI Auditor Training presentation deck from 2015

  • Audit Program
This resource was published on 30 November 2016

Supplier Conference 2016 (China) - Day 2 - Presentation Pack

Slides

Day 2 presentation pack from the 2016 Supplier Conference held in Shanghai.

This resource was published on 30 November 2016

Supplier Conference 2016 (China) - Day 1 - Presentation Pack

Slides

Day 1 presentation pack from the 2016 Supplier Conference held in Shanghai.

This resource was published on 26 October 2016

Managing APIs In Manufacturing Effluent Webinar Part 3 - 25th October 2016 - Slides

Document

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.

  • Environment
  • Pharmaceuticals In The Environment
This resource was published on 20 June 2016

Managing APIs In Manufacturing Effluent Webinar Part 2 - 15th June 2016 - Recording

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.

  • Environment
  • Pharmaceuticals In The Environment
This resource was published on 20 June 2016

Managing APIs In Manufacturing Effluent Webinar Part 2 - 15th June 2016 - Slides

Document

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.

  • Environment
  • Pharmaceuticals In The Environment
This resource was published on 24 February 2016

PSCI Social Media Guide For Members

Organisational Information

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

Managing APIs In Manufacturing Effluent Webinar Part 1 - 27th January 2016 - Slides

Document

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.

  • Environment
  • Pharmaceuticals In The Environment
This resource was published on 3 February 2016

Managing APIs In Manufacturing Effluent Webinar Part 1 - 27th January 2016 - Recording

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.

  • Environment
  • Pharmaceuticals In The Environment
This resource was published on 1 February 2016

Audit Sharing Platform Supplier User Guide

Document

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.

  • Audit Program
This resource was published on 20 January 2016

A Risk Based Approach To Managing APIs In Manufacturing Effluent

Document

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.

  • Environment
  • Pharmaceuticals In The Environment
This resource was published on 6 January 2016

PSCI Membership Fees Structure

Organisational Information

This document explains the PSCI membership fees structure.

New version added: November 2021

This resource was published on 14 October 2015

Supplier Conference 2015 (India) - Presentation Pack

Slides

Full presentation pack from the 2015 Supplier Conference held in Mumbai, India.

This resource was published on 9 September 2015

Supplier Conference 2015 (India) - Brochure

Document

2015 India Supplier Conference Brochure

This resource was published on 3 August 2015

Pre-Audit Document Request List

Document

Pre-Audit Document Request List

  • Audit Program
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