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 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.

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

The Principles

Document

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

2015 India Supplier Conference Brochure

Document

2015 India Supplier Conference Brochure

2015 India Supplier Conference Presentation Pack

Document

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

2016 China Supplier Conference Presentation Pack DAY 1

Document

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

2016 China Supplier Conference Presentation Pack DAY 2

Document

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

2017 AGM Slide Deck - Day 1

Document Members Only

2017 AGM Day 1 slide deck
Wednesday 25th October

2017 AGM Slide Deck - Day 2

Document Members Only

2017 AGM Day 2 slide deck
Thursday 26th October

2017 AGM Slide Deck - New Member Introduction

Document Members Only

2017 AGM new member introduction slide deck
Tuesday 24th October

2017 India Conference Presentation Pack Day 1

Document

2017 India Conference Presentation Pack Day 1

2017 India Conference Presentation Pack Day 2

Document

2017 India Conference Presentation Pack Day 2

2017 India Conference Presentation Pack Day 3

Document

2017 India Conference Presentation Pack Day 3

2017 India Conference Presentation Pack Early Bird Dekra

Document

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

2017 India Conference Presentation Pack Early Bird PSCI Basics

Document

2017 India Conference Presentation Pack Early Bird PSCI Basics

2017 Supplier Conference Hyderabad, India, Agenda

Document

Agenda for 2017 Supplier Conference in Hyderabad, India

2018 PSCI AGM Day 1 New Members Introduction

Document Members Only

INTRODUCTION FOR NEW MEMBERS & COMPANIES INTERESTED IN JOINING

Tuesday 23rd October 2018

2018 PSCI AGM Day 2 slide pack

Document Members Only

2018 Annual General Meeting
Wednesday 24th October 2018

2018 PSCI AGM Day 3 slide pack

Document Members Only

2018 Annual General Meeting
Thursday 25th October 2018

2018 Spring Meeting Slide Deck - New Member Introduction

Document Members Only

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

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 - Thursday 12th April

Document Members Only

2018 Spring Meeting slide deck
Thursday 12th April

2018 Spring Meeting Slide Deck - Transparency International

Document Members Only

2018 Spring Meeting slide deck
Transparency International

2018 Spring Meeting Slide Deck - Wednesday 11th April

Document Members Only

2018 Spring Meeting slide deck
Wednesday 11th April

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.

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.

Content Version 4, November 2016

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 4, November 2016

Antitrust Policy

Document

The PSCI operates in compliance with the antitrust and competition laws of all applicable countries, including the United States (both state and federal) and European Union. To that end, PSCI has drafted these competition guidelines to serve as a general code of conduct for PSCI as well as its constituent members.

Corrective Action Plan Template

Document

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).

Data Sharing Agreement

Document

Supplier Data Sharing Agreement (updated Nov 2018)

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

Content Version 5, May 2018

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 4, November 2016

Green Chemistry Pharma Week Photo Report

Document

Green Chemistry Pharma Week Photo Report February 2017

Introduction presentation for PSCI audit opening meeting

Document

Introduction presentation for PSCI audit opening meeting

Joint Audit Process Diagram

Document

Through the application of the PSCI Principles, better social, economic and environmental outcomes will result for all those involved in the pharmaceutical supply chain. As an industry, we will focus our efforts on positive social and environmental changes, and building supply chain capacity.

Pre-Audit Document Request List

Document

Pre-Audit Document Request List

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.

PSCI 2018-2020 Strategy

Document

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

PSCI Articles of Incorporation

Document

PSCI Articles of Incorporation

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 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.

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 Auditor Training 2015

Document

PSCI Auditor Training presentation deck from 2015

PSCI Auditor Training 2017 Hyderabad

Document

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

PSCI Auditor Training 2017 Shanghai (Day 1)

Document

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

PSCI Auditor Training 2017 Shanghai (Day 2)

Document

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

PSCI Auditor Training 2017 Shanghai (Day 3)

Document

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

PSCI Branding Guidelines

Document

PSCI Branding Guidelines

PSCI Bylaws

Document

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

PSCI CAPR template in Excel format

Document

PSCI CAPR template in Excel format

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