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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All member audit call - minutes

Document Members Only

During this call the audit sharing committee updated members on the status of audit sharing within the PSCI, and discussed possible paths for increasing audit sharing in the future.

The call was held on 13th August 2019.

You can watch the recording here.
You can access the slides here.

All member audit call - slides

Document Members Only

During this call the audit sharing committee updated members on the status of audit sharing within the PSCI, and discussed possible paths for increasing audit sharing in the future.

The call was held on 13th August 2019.

You can watch the recording here.
You can access the minutes here.

All member audit call - recording

Video Link Members Only

During this call the audit sharing committee updated members on the status of audit sharing within the PSCI, and discussed possible paths for increasing audit sharing in the future.

The call was held on 13th August 2019.

You can access the slides here.
You can access the minutes here.

Maturity model common framework

Document Members Only

A common framework for PSCI maturity models, developed in April 2019. Each Model will have different technical content depending on the subject. This is a common framework to ensure alignment and consistency.

Webinar slide deck: Antimicrobial Resistance

Document

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

Video Link

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

Document

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

Consolidated PEC:PNEC Calculator Tool for assessing API discharges

Document

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

Document

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

PSCI Shared Audit Program Brochure

Document

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

PSCI Member Welcome Pack

Document

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.

Data Sharing Agreement

Document

Supplier Data Sharing Agreement (updated June 2019)

Emergency Plan Template

Document

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

Document

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

Document

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

Video Link

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

Slide template (printer friendly)

Document Members Only

Please use this template to build any presentations delivered under the name of PSCI. When you intend on printing the slides, please use this version of the document to minimise ink use.

To add footers, click Insert > Header and Footer > Tick 'Page Numbers' and 'Footer' and type in the text box > Click 'Add to All'

Last updated June 2019

Slide template

Document Members Only

Please use this template to build any presentations delivered under the name of PSCI.

To add footers, click Insert > Header and Footer > Tick 'Page Numbers' and 'Footer' and type in the text box > Click 'Add to All'

Last updated June 2019

Membership Application Assessment Tool

Document Members Only

The Membership Application Assessment Tool produced by the Governance Committee to aid the Board's decision making process. Last updated 3 June 2019.

2019 Spring Meeting Attendee List

Document Members Only

This document was distributed at the Spring Meeting and shows who was in attendance.

2019 Spring Meeting Slide Deck - Thursday 16th May

Document Members Only

Slide deck from the 2019 Spring Meeting - Thursday 16th May.

The slides are as shown during the meeting.

2019 Spring Meeting Slide Deck - Wednesday 15th May

Document Members Only

The slide deck from the 2019 Spring Meeting - Wednesday 15th May.

Please note, the EcoVadis slides have not been included in this distribution. Everything else is as was shown at the meeting.

PSCI Auditor Training 2018 Vienna

Document

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

Management Systems Maturity Model

Document

This maturity model has been developed: (1) as a tool to help you assess the current state of your organization’s Management Systems relative to PSCI’s Supplier Audit Questionnaire and (2) to understand what PSCI Member Companies look for in their suppliers.

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

Document

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

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

Document

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 (WORD VERSION)

Document

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

Version 5, February 2019

Chinese translation uploaded August 2019.

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

Document

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

Version 5, February 2019

PSCI Branding Guidelines

Document

PSCI Branding Guidelines

PSCI 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.

PSCI Audit Guidance

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.

2018 PSCI AGM Day 3 slide pack

Document Members Only

2018 Annual General Meeting
Thursday 25th October 2018

2018 PSCI AGM Day 2 slide pack

Document Members Only

2018 Annual General Meeting
Wednesday 24th October 2018

2018 PSCI AGM Day 1 New Members Introduction

Document Members Only

INTRODUCTION FOR NEW MEMBERS & COMPANIES INTERESTED IN JOINING

Tuesday 23rd October 2018

Webinar recording - Introduction to UN Guiding Principles on Business and Human Rights - 16th October 2018

Link Members Only

This is a recording of the PSCI webinar on the UN Guiding Principles which took place on 16th October 2018.

Webinar slide deck : Introduction to UN Guiding Principles on Business and Human Rights - 16th October 2018

Document Members Only

This is the slide deck from the PSCI webinar on the UN Guiding Principles which took place on 16th October 2018.

PSCI Principles E-learning Tool

Link

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

PSCI Standard Operating Procedures

Document Members Only

PSCI Standard Operating Procedures

Version 5.0 added: July 2018

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

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.

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

Link

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 Partnerships Strategy

Document Members Only

PSCI engages with a wide range of organisations and individuals in a variety of partnership arrangements. In the PSCI Strategy 2018-2020, we dedicated a Strategic Objective to building external partnerships (Strategic Objective 3.1). Strengthening our approach to Partnerships will be an important theme over the next two-three years to help us achieve our vision to establish and promote responsible practices that will continuously improve social, health, safety and environmentally sustainable outcomes for member supply chain.

This strategy formalises PSCI's approach to partnerships. It explains what we look for from partners and who we partner with (pages 2-3), the PSCI partnering process (pages 3-6), and how we work with partners once the relationship is established (page 7).

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

Link

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.

2018 Spring Meeting Slide Deck - Novartis 3rd Party Risk Management Programme

Document Members Only

2018 Spring Meeting slide deck
Novartis 3rd Party Risk Management Programme

2018 Spring Meeting Slide Deck - Transparency International

Document Members Only

2018 Spring Meeting slide deck
Transparency International

2018 Spring Meeting Slide Deck - Thursday 12th April

Document Members Only

2018 Spring Meeting slide deck
Thursday 12th April

2018 Spring Meeting Slide Deck - Wednesday 11th April

Document Members Only

2018 Spring Meeting slide deck
Wednesday 11th April

2018 Spring Meeting Slide Deck - New Member Introduction

Document Members Only

2018 Spring Meeting new member introduction slide deck
Tuesday 10th April

PSCI 2018-2020 Strategy

Document

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

PSCI Membership Types

Document

This document outlines the criteria, responsibilities and benefits of the two PSCI membership types - Full and Associate

New version added: July 2018

PSCI Auditor Training 2017 Shanghai (Day 3)

Document

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

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