Resources

Information on PSCI and resource materials on pharmaceutical supply chain sustainability.

The resources are particularly targeted at companies working in the supply chain – our suppliers – who are warmly encouraged to make free use of all the materials here.

We will continue to build this section over time. If you have any suggestions on how we can improve it please contact us.

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The PSCI Principles

The PSCI Principles

Organisational Information
26 Nov 2019

The 2019 revision of the PSCI Principles (PSCI Principles v2.0) was approved by the membership on Tuesday 12th November, 2019, at the Annual General Meeting in Cambridge, Massachusetts.

The PSCI Principles for Responsible Supply Chain Management set the standard for human rights, ethics, labor, health and safety, environment and related management systems.The Principles may be voluntarily supported by any business in the pharmaceutical industry.

The Principles now include a specific reference to human rights and the UN Guiding Principles on Business and Human Rights, an enhanced ethics section, and new clauses on resource efficiency and sustainable sourcing.

The new version is currently available in English only. Translations will added in the coming weeks.

Modern Slavery Webinar: Recording

Webinar Video Link
28 Oct 2019

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:

  • Peter Nestor, Human Rights Manager at Novartis

You can access the slide deck here.

Modern Slavery Webinar: Slide deck

Slides
28 Oct 2019

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:

  • Peter Nestor, Human Rights Manager at Novartis

You can watch the recording here.

PSCI SDG mapping

PSCI SDG mapping

Organisational Information
27 Aug 2019

Graphic of PSCI SDG mapping. We recently mapped PSCI Principles and activities against the UN's Sustainable Development Goals. It was an interesting exercise, revealing where our missions align. We plan to build on this by applying the SDG framework in ongoing and future workstreams.

Click below to download the full graphic:

Introduction presentation for PSCI audit opening meeting

Document
1 Aug 2019

Introduction presentation for PSCI audit opening meeting.

Version 1 - 07/02/2017
Version 2 - 01/08/2019

2019 India Supplier Conference: Agenda

Agenda
1 Aug 2019

Agenda for the 2019 Supplier Conference held in Hyderabad, India.

Full PSCI SAQ & Audit Report Template for Core Suppliers, External Manufacturers, Component and Material Suppliers (WORD VERSION)

Document
29 Jul 2019

MS Word version of the PSCI Self Assessment Questionnaire and Audit Report Template for Core Suppliers, External Manufacturers, Component and Material Suppliers.

Version 5, February 2019
Chinese translation added July 2019.

Select your preferred language from the options below

Webinar slide deck: Antimicrobial Resistance

Slides
23 Jul 2019

This webinar initially aired on 18th July 2019

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;
  • Neil Parke, Global HSE Consultant at Lilly.

Webinar recording: Antimicrobial Resistance

Webinar Video Link
23 Jul 2019

This webinar initially aired on 18th July 2019

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;
  • Neil Parke, Global HSE Consultant at Lilly.

2019 China Supplier Conference : Agenda

Agenda
22 Jul 2019

Agenda for the 2019 Supplier Conference held in Hangzhou, China.

Select your preferred language from the options below

Consolidated PEC:PNEC Calculator Tool for assessing API discharges

Document
11 Jul 2019

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.

PSCI Overview Presentation

PSCI Overview Presentation

Organisational Information
5 Jul 2019

Launched in August 2017. The deck summarises what the PSCI is and does and other useful information including the membership structure and how to join the initiative.

Updates:

  • Sept. 2017
  • Dec. 2017
  • Oct. 2018
  • Apr. 2019
  • Nov. 2019

PSCI Shared Audit Program Brochure

Document
4 Jul 2019

This document gives a summary of the PSCI Shared 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 shared Audit
  • What happens in a PSCI Shared Audit?
  • Who carries out the audit?

Last updated July 2019

Data Sharing Agreement

Document
3 Jul 2019

Supplier Data Sharing Agreement (latest version August 2019)

PSCI Member Welcome Pack

PSCI Member Welcome Pack

Organisational Information
3 Jul 2019

This PSCI Member Welcome Pack is for new members of the PSCI. It sign-posts important documents and resources and gives advice on how to become fully integrated into the organisation.

Emergency Plan Template

Template
28 Jun 2019

This template was produced by Aaron Duff, Director of EHS&S at Johnson & Johnson, and was showcased during the PSCI Webinar: Emergency Preparedness and Response on 27th June 2019.

Crisis Management Plan Template

Template
28 Jun 2019

This template was produced by Aaron Duff, Director of EHS&S at Johnson & Johnson, and was showcased during the PSCI Webinar: Emergency Preparedness and Response on 27th June 2019.

Webinar slide deck: Emergency Preparedness and Response

Slides
28 Jun 2019

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

Webinar recording: Emergency Preparedness and Response

Webinar Video Link
28 Jun 2019

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

PSCI Auditor Training 2018 Vienna

Document
17 May 2019

Presentation Pack from the 2018 PSCI Auditor Training, 4 - 5 December in Vienna, Austria

Management Systems Maturity Model

Document
16 May 2019

This maturity model has been developed:

  • as a tool to help you assess the current state of your organization’s Management Systems relative to PSCI’s Supplier Audit Questionnaire and
  • to understand what PSCI Member Companies look for in their suppliers.
Select your preferred language from the options below
PSCI Pamphlet

PSCI Pamphlet

Document
8 May 2019

This document is for members to use when promoting the PSCI. This version is the A4 document for in-house printing, however US paper size and commercial printing documents are available upon request.

To request alternative versions, please contact the PSCI Secretariat.

Video Introduction to the PSCI

Organisational Information Video
8 May 2019

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:

PSCI 2018 Annual Report

PSCI 2018 Annual Report

Document
5 Apr 2019

"2018 has seen PSCI gain more members, reach more suppliers, perform more audits and host more events than ever before. The growth in our membership is a huge achievement but it is the growth in our impact that I am most proud of.

In the pages of this report you will read about our other achievements this year: holding members accountable, setting up a Board Advisory Panel, sharing data on suppliers’ carbon emissions, and a new visual brand identity and logo. Perhaps the most important pages are the ones that show our impact; the suppliers trained, the audits completed and followed up, the downloads of advisory documents from our technical library."

Dr Birgit Skuballa, Bayer (Chair of the PSCI during 2018)

Webinar slide deck - Water Stress Management - 28th March 2019

Slides
2 Apr 2019

These are the slides for the webinar on ways to assess and manage “Water Stress” inside your company and in your supply chain.

Webinar recording - Water Stress Management - 28th March 2019

Webinar Video Link
2 Apr 2019

This is a recording of the webinar on ways to assess and manage “Water Stress” inside your company and in your supply chain.

Webinar slide deck - PSCI SAQ & Audit Report Template Update - 20th February 2019

Slides
22 Feb 2019

Please find the slide deck for the recent webinar on the PSCI SAQ & Audit Report Template Update.

Webinar recording - PSCI SAQ & Audit Report Template Update - 20th February 2019

Webinar Video Link
22 Feb 2019

Please find a link to the webinar on the latest SAQ & Audit Report Template Update.

Abbreviated PSCI SAQ & Audit Report Template for Service Providers & General Manufacturers (WORD VERSION)

Document
7 Feb 2019

WORD VERSION
Abbreviated PSCI Self Assessment Questionnaire & Audit Report Template for Service Providers & General Manufacturers.

Version 5, February 2019

Abbreviated PSCI SAQ & Audit Report Template for Service Providers & General Manufacturers (EXCEL VERSION)

Document
7 Feb 2019

EXCEL VERSION
Abbreviated PSCI Self Assessment Questionnaire & Audit Report Template for Service Providers & General Manufacturers.

For optimum functionality, we recommend using the most up to date version Microsoft Excel. If you only have access to Excel 2003 or earlier, we recommend using the Word version of the SAQ.

Content Version 5, February 2019

Full PSCI SAQ & Audit Report Template for Core Suppliers, External Manufacturers, Component and Material Suppliers (EXCEL VERSION)

Document
7 Feb 2019

EXCEL VERSION
PSCI Self Assessment Questionnaire and Audit Report Template for Core Suppliers, External Manufacturers, Component and Material Suppliers

For optimum functionality, we recommend using the most up to date version Microsoft Excel. If you only have access to Excel 2003 or earlier, we recommend using the Word version of the SAQ.

Content Version 6, February 2019

PSCI Branding Guidelines

Organisational Information
3 Dec 2018

PSCI Branding Guidelines

PSCI Audit Guidance

PSCI Audit Guidance

Document
14 Nov 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.

PSCI Audit Sharing Platform Member User Guide

Document
14 Nov 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.

PSCI Introductory Training for Auditors Slides

Slides
28 Oct 2018

These slides were shown as part of a Auditor Training webinar, which can be found here.

This training was delivered in September 2018.

PSCI Introductory Training for Auditors

Webinar Video Link
26 Oct 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.

PSCI Principles E-learning Tool

PSCI Principles E-learning Tool

Link
10 Oct 2018

This is a training tool for PSCI members and their suppliers on the PSCI principles.

2018 China Supplier Conference Presentation Pack Day 2

Document
21 Sep 2018

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

2018 China Supplier Conference Presentation Pack Day 1

Document
21 Sep 2018

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

PSCI Anti-trust Statement EN CN

Document
20 Aug 2018

PSCI Anti-trust Statement in English and Chinese

2018 Supplier Conference Hyderabad, India, Agenda

Agenda
1 Aug 2018

This is the agenda for 2018 PSCI India Supplier Conference.

Webinar recording - Evaluating supplier ethics and compliance practices and programs - 25th July 2018

Webinar Video Link
26 Jul 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.

Webinar slide deck - Evaluating supplier ethics and compliance practices and programs - 25th July 2018

Slides
26 Jul 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.

2018 Supplier Conference Shanghai, China, Agenda

Agenda
26 Jul 2018

This is the agenda for 2018 PSCI China Supplier Conference.

Select your preferred language from the options below

Webinar slide deck - managing APIs in manufacturing effluent Part 4 - 10th July 2018

Slides
11 Jul 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.

Webinar recording - managing APIs in manufacturing effluent Part 4 - 10th July 2018

Webinar Video Link
11 Jul 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.

PSCI Member Audit Sharing Target

Document
11 Jul 2018

This document defines the PSCI member audit sharing target.
Approved by the PSCI Board in May 2018.
Applicable from January 2019.

Predicted-No-Effect-Concentration (PNEC) resource links

Link
11 Jun 2018

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.
PSCI Inaugural Annual Report 2017 / 2018

PSCI Inaugural Annual Report 2017 / 2018

Document
19 Mar 2018

Inside the report, you will find highlights and achievements from 2017, a busy and important year for PSCI, and our plans for 2018.

PSCI 2018-2020 Strategy

Document
17 Jan 2018

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

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