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 Anti-trust Statement EN CN

Document

PSCI Anti-trust Statement in English and Chinese

PSCI Standard Operating Procedures

Document Members Only

PSCI Standard Operating Procedures

Version 5.0 added: July 2018

2018 Supplier Conference Hyderabad, India, Agenda

Document

This is the agenda for 2018 PSCI India Supplier Conference.

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

Link

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

Document

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

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This is the agenda for 2018 PSCI China Supplier Conference.

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 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.

PSCI Member Application Flow Chart

Document Only

This document outlines the process that PSCI follows to review and approve (or not) new member applications.

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 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.

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)

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

PSCI Auditor Training 2017 Shanghai (Day 2)

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

PSCI Auditor Training 2017 Shanghai (Day 1)

Document

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

2017 AGM Slide Deck - Day 2

Document Members Only

2017 AGM Day 2 slide deck
Thursday 26th October

2017 AGM Slide Deck - Day 1

Document Members Only

2017 AGM Day 1 slide deck
Wednesday 25th October

2017 AGM Slide Deck - New Member Introduction

Document Members Only

2017 AGM new member introduction slide deck
Tuesday 24th October

PSCI Audit Sharing Platform Member User Guide Training Video

Video Link Members Only

This is a Training Video on how to navigate the PSCI Audit Sharing Platform for member users. The video is split into 4 parts as shown below:

  1. How to access the Platform (0:00 – 04:38)
  2. The Suppliers List (04:38 – 11:39)
  3. Suppliers pages; how to see and upload Audits, SAQs and CAPRs (11:40 – 20:24)
  4. The new SAQ and Audit lists (20:25 – end)

For further assistance please refer to the Member User Guide or contact us at info@pscintiative.org.

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

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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

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.

PSCI Membership Agreement

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PSCI Membership Agreement. Last updated in 2017.

PSCI Articles of Incorporation

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PSCI Articles of Incorporation

PSCI Bylaws

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Bylaws of the Pharmaceutical Supply Chain Initiative. Last updated in Feb 2017.

2017 India Conference Presentation Pack Day 2

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2017 India Conference Presentation Pack Day 2

2017 India Conference Presentation Pack Early Bird Dekra

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

2017 India Conference Presentation Pack Early Bird PSCI Basics

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2017 India Conference Presentation Pack Early Bird PSCI Basics

2017 India Conference Presentation Pack Day 3

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2017 India Conference Presentation Pack Day 3

2017 India Conference Presentation Pack Day 1

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2017 India Conference Presentation Pack Day 1

2017 Supplier Conference Hyderabad, India, Agenda

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Agenda for 2017 Supplier Conference in Hyderabad, India

Green Chemistry Pharma Week Photo Report

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Green Chemistry Pharma Week Photo Report February 2017

PSCI Auditor Training 2017 Hyderabad

Document

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

PSCI CAPR template in Excel format

Document

PSCI CAPR template in Excel format

PSCI Auditor Training 2015

Document

PSCI Auditor Training presentation deck from 2015

Introduction presentation for PSCI audit opening meeting

Document

Introduction presentation for PSCI audit opening meeting.

v1 - 07/02/2017
v2 - 01/08/2019

2016 China Supplier Conference Presentation Pack DAY 2

Document

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

2016 China Supplier Conference Presentation Pack DAY 1

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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

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.

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

Link

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

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

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

PSCI Social Media Guide for Members

Document

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.

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

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.
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