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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PSCI Newsletter, December 2019

Link
17 Dec 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.

Ethics Webinar: Recording

Ethics Webinar: Recording

Webinar Video Link
17 Dec 2019

This webinar first aired on Thursday 5th December 2019.
The recording is attached.

In this webinar we explored Ethics for the pharmaceutical supply chain. Our speakers covered how to design an anti-bribery and corruption programme and PSCI’s expectations regarding business ethics.

We were delighted to be joined by the following speakers:

  • Manjit Singh, Associate Director Corporate Sustainability at Centrient
  • Mark Pearson, Principal at Deloitte
  • Dimple Thomas, Senior Manager at Deloitte
  • Ethics
  • Business Integrity & Fair Competition
  • Bribery & Corruption

Ethics Webinar: Slide deck

Slides
17 Dec 2019

The slides from the PSCI Ethics Webinar which first aired on Thursday 5th December 2019.

  • Ethics
  • Business Integrity & Fair Competition
  • Bribery & Corruption
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.

  • Ethics
  • Human Rights and Labor
  • Health & Safety
  • Environment
  • Management Systems

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.

  • Human Rights and Labor
  • Freely Chosen Employment
  • Wages, Benefits & Working Hours

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.

  • Human Rights and Labor
  • Freely Chosen Employment
  • Wages, Benefits & Working Hours

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
  • Ethics
  • Human Rights and Labor
  • Health & Safety
  • Environment
  • Management Systems
  • Audit Programme

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.
  • Pharmaceuticals In The Environment
  • Anti-Microbial Resistance

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.
  • Pharmaceuticals In The Environment
  • Anti-Microbial Resistance

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.

  • Environment
  • Spills & Releases
  • Waste Management
  • Water Use & Management
  • Pharmaceuticals In The Environment
  • Anti-Microbial Resistance
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

  • Audit Programme

Data Sharing Agreement

Document
3 Jul 2019

Supplier Data Sharing Agreement (latest version August 2019)

  • Audit Programme

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

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:

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

  • Ethics
  • Human Rights and Labor
  • Health & Safety
  • Environment
  • Management Systems
  • Audit Programme

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

  • Audit Programme

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

  • Audit Programme
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.

  • Audit Programme
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.

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.

  • Environment
  • Pharmaceuticals In The Environment
  • Anti-Microbial Resistance

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.

  • Environment
  • Pharmaceuticals In The Environment
  • Anti-Microbial Resistance

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.
  • Pharmaceuticals In The Environment

PSCI 2018-2020 Strategy

Document
17 Jan 2018

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

Webinar slide deck - Audit Programme Webinar, 4th Oct 2017

Slides
5 Oct 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.

PSCI Auditor Evaluation Tool

Document
26 Sep 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.

  • Audit Programme

2017 India Conference Presentation Pack Day 2

Slides
19 May 2017

2017 India Conference Presentation Pack Day 2

2017 India Conference Presentation Pack Early Bird Dekra

Slides
19 May 2017

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

2017 India Conference Presentation Pack Early Bird PSCI Basics

Slides
19 May 2017

2017 India Conference Presentation Pack Early Bird PSCI Basics

2017 India Conference Presentation Pack Day 3

Slides
19 May 2017

2017 India Conference Presentation Pack Day 3

2017 India Conference Presentation Pack Day 1

Slides
19 May 2017

2017 India Conference Presentation Pack Day 1

2017 Supplier Conference Hyderabad, India, Agenda

Agenda
30 Mar 2017

Agenda for 2017 Supplier Conference in Hyderabad, India

2016 China Supplier Conference Presentation Pack DAY 2

Slides
30 Nov 2016

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

2016 China Supplier Conference Presentation Pack DAY 1

Slides
30 Nov 2016

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

Webinar slide deck - managing APIs in manufacturing effluent Part 3 - 25th October 2016

Slides
26 Oct 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.

  • Environment
  • Pharmaceuticals In The Environment

Webinar recording - managing APIs in manufacturing effluent Part 2 - 15th June 2016

Webinar Video Link
20 Jun 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
  • Environment
  • Pharmaceuticals In The Environment

Webinar slide deck - managing APIs in manufacturing effluent Part 2 - 15th June 2016

Slides
20 Jun 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
  • Environment
  • Pharmaceuticals In The Environment

Webinar slide deck - managing APIs in manufacturing effluent Part 1 - 27th Jan 2016

Slides
3 Feb 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.
  • Environment
  • Pharmaceuticals In The Environment

Webinar recording - managing APIs in manufacturing effluent - 27th Jan 2016

Webinar Video Link
3 Feb 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.
  • Environment
  • Pharmaceuticals In The Environment

PSCI Audit Sharing Plaform Supplier User Guide

Document
1 Feb 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.

  • Audit Programme

A risk based approach to managing APIs in manufacturing effluent

Document
20 Jan 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.

  • Environment
  • Pharmaceuticals In The Environment

2015 India Supplier Conference Presentation Pack

Slides
14 Oct 2015

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

Corrective Action Plan Template

Document
13 Oct 2015

This document can be used by suppliers to document agreed corrective actions, 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).

  • Audit Programme

2015 India Supplier Conference Brochure

Document
9 Sep 2015

2015 India Supplier Conference Brochure

Pre-Audit Document Request List

Document
3 Aug 2015

Pre-Audit Document Request List

  • Audit Programme

Example RBEAP solvent

Document
10 Jul 2015

Example RBEAP solvent

  • Health & Safety
  • Occupational Health & Industrial Hygiene
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