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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Guidance For Implementing The Principles

Document

The Implementation Guidance Document provides examples of business practices and performance related to the Principles.

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 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 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 China Supplier Conference Presentation Pack Day 1

Document

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

2018 China Supplier Conference Presentation Pack Day 2

Document

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

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

2018 Supplier Conference Hyderabad, India, Agenda

Document

This is the agenda for 2018 PSCI India Supplier Conference.

2018 Supplier Conference Shanghai, China, Agenda

Document

This is the agenda for 2018 PSCI China Supplier Conference.

3M Respirator Selection Guide

Link

The 3M™ Respirator Selection Guide includes a list of chemicals for which 3M respirators can be recommended. This information can be used to supplement general industrial hygiene knowledge.

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

Additive Effects Workshop 1

Document

Additive Effects Workshop 1

Additive Effects Workshop 1 answer sheet

Document

Additive Effects Workshop 1 answer sheet

Additive Effects Workshop 2

Document

Additive Effects Workshop 2

Additive Effects Workshop 2 answer sheet

Document

Additive Effects Workshop 2 answer sheet

Analytical Method Development Update

Document

Johnson & Johnson
Worldwide Health & Safety
Industrial Hygiene Analytical Method Development

Animal Experimentation

Document

Novo Nordisk's position on Animal Experimentation.

Animal Studies

Link

The link provides Bayer’s principles for animal welfare and animal testing and their responsibility for the safety of our products and thus for people, animals and the environment, and the well-being of laboratory animals.

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.

Basic Informatoin for OEL PBOEL-HHC IPI and API

Document

Basic Informatoin for OEL PBOEL-HHC IPI and API

Basic principles ventilation

Document

Basic principles ventilation

Basic principles ventilation part 2 - very hazardous substances

Document

Basic principles ventilation part 2 - very hazardous substances

Bayesian statistics

Document

Industrial Hygiene Monitoring
Introduction To Bayesian Statistics
Dave Pearson, Djon Gentry, Tim Allers

Behaviour in Competition

Document

Roche's Guide to Competition Law.

Best Management Practices for Leak and Spill Control

Document

Keeping a facility clean helps improve productivity and employee morale. In addition, it
presents a positive image to customers, stakeholders and the community. A clean facility can also help ensure greater compliance with environmental, health and safety regulations. Leaks and spills can happen anywhere – from the front office to the shipping dock; and beyond. These spills create waste and can lead to costly environmental fines - especially if the spill leaves the facility. Leaks and spills can also contribute to worker injuries, causing piles of medical bills, workman’s compensation claims and lost work time.

Bioethics Clinical Trials

Document

Bioethics at Novo Nordisk. It is the expression used for all ethical issues related to the use of life science technologies in the discovery, development and production of pharmaceutical products. This covers the ethical aspects of the use of human biological material, animals and gene technology in research, and clinical trials.

Biological Hazards

Document

Biological hazards arise from exposure to hormones, viruses, fungi, bacteria or any other living organisms that can cause harm, illness, or damage to the human body.

Business Code of Conduct

Document

The Novo Nordisk Way, an example of the Business Code of Conduct.

Carcinogen Control Program

Document

A power-point on carcinogens from Environment Health & Safety.

Carcinogens, Hierarchy of Controls

Document

Best practices hierarchy of controls for carcinogens

Chemical Agents Management System

Document

A Management Systems Approach for Chemical Agents

Chemical hazard communication

Document

Working safely with chemicals

Chemical Hazards

Document

Each chemical is different from the next one and therefore each chemical has different characteristics that help define the hazards that may be present.

Chemical Risk Assessment - basic characterization

Document

Chemical Risk Assessment & Exposure Monitoring
Basic Elements / Characterisation

Child Labor & Young Workers, Additional Resources

Document

Links to additional resources including organisations involved in ending child labor and reference material.

Child Labor & Young Workers, Overview

Document

An introduction to child labor & young workers.

Child Labor & Young Workers, Sample Action Plan

Document

An example of how to deal with child labor.

Climate Change Position

Document

An example is Novo Nordisk's climate strategy, which is developed in accordance with the Greenhouse Gas Protocol. It includes all scope 1 and 2 emissions within operational control and scope 3 emissions that are significant in size or significant from a stakeholder perspective. Towards 2020 their focus is on reporting and reducing emissions from global production sites, company cars, product distribution and business travel.

http://www.novonordisk.com/about-novo-nordisk/novo-nordisk-in-brief/positions/climate-change.html

Code of Ethics

Document

This Code of Ethics defines Sanofi-Aventis expectations when conducting business. It is provided as a resource to guide its employees in dealing with issues, both inside and outside the Group, that may be encountered as part of day to day functional responsibilities.

Confined Space Fatality - Investigation Report

Document

Example of a document produced after a fatality.

Containment Testing Protocol

Document

Industrial Hygiene FAT and SAT Performance Evaluation Protocol

Contract Manufacturer's Journey to Higher Containment

Document

"A CMO’s Journey to Higher Containment" slideshow.

Control Banding

Document

Control Banding

Controlling exposures to API

Document

PowerPoint from ISPE on controlling exposure to Active Pharmaceutical Agents.

Controlling Exposures to API in Chemical Production

Document

ISPE slideshow concerning control of exposure to API in Chemical Production.

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).

CRA EM Index (Consolidated)

Document

Chemical Risk Assessment & Exposure Monitoring Index - Consolidated

Data Sharing Agreement

Document

Supplier Data Sharing Agreement (updated Nov 2018)

Decision trees to make up IH sampling plans

Document

Examples decision trees to make up IH sampling plans

Dust Explosion Data - How to Identify and Communicate the Hazard

Document

PowerPoint on dust hazards, their identification and communication.

Employee notification IH

Document

Employee notification of industrial hygiene sampling results
IH Maturity Ladder Level 5

Engineering Controls for Exposure to APIs

Document

PowerPoint on engineering controls for exposure to active pharmaceutical ingredients.

Environmental Handbook - Danish Environment Ministry

Document

A practical handbook for suppliers and sub-suppliers on good environmental practices, prepared by the Danish Ethical Trading Initiative (DIEH) in cooperation with COWI and the Danish Federation of Small and Medium-Sized Enterprises as part of a joint project between DIEH and the Danish Environmental Protection Agency.

ESP - Practical Handbook on Business and Human Rights

Link

The practical handbook on Business and Human Rights.

ETI Freedom of Association and Collective Bargaining

Link

This briefing document seeks to explain clearly what freedom of association and the right to collective bargaining mean.

Example Accident Investigation - Dropped Panel Fatality

Document

Accident Investigation slideshow.

Example Action Plan Physical Agents

Document

PowerPoint covering "Approach Physical Agents Program".

Example analytical method Ceftobiprole

Document

This report describes an air sampling and analytical method for the determination of airborne Ceftobiprole medocaril (BAL 5788). This method was developed and evaluated by the Catholic University of Leuven at the request of Janssen Pharmaceutica Beerse (Belgium).

Example Chemical Risk Assessment and Exposure Monitoring Program

Document

Chemical Risk Assessment and Exposure Monitoring Program

Example IH report Cilag

Document

Dust Measurements during Charging and Discharging of the mechanical Dryer in Building 20 of TIC 1097 in ILC-Dover G2PacTM

Example IH report isolator Mannitol

Document

Example IH report isolator Mannitol

Example IH report Methylphenidate FBG3

Document

Example IH report Methylphenidate FBG3

Example IH report Methylphenidate HCl K3

Document

Example IH report Methylphenidate HCl K3

Example IH sample record sheet

Document

Example IH sample record sheet

Example Qualitative chemical risk assessment Cork

Document

Example Qualitative chemical risk assessment Cork

Example RBEAP API

Document

IH Air Monitoring Unit Risk Based Approach Decision Making

Example RBEAP solvent

Document

Example RBEAP solvent

Example Risk Analysis carcinogen acrylonitrile

Document

Example Risk Analysis carcinogen acrylonitrile

Example Risk Assessment and Monitoring Program CP

Document

Chemical Risk Assessment & Exposure Monitoring
Chemical Production & Development Janssen Pharma Geel Belgium
Michel Vangeel - Prevention Department

Example SDS Risperidone

Document

Example SDS Risperidone (version with GHS info not available yet)

Example summary sheet Risperidone

Document

Example summary sheet Risperidone

External H&S Resource Libraries

Document

External H&S Resource Libraries

External Manufacturing EHS Best Practices

Document

This paper provides an overview of some of the current best practices which have been developed for external manufacturing for both the Chemical and Pharmaceutical industries.

Fair Treatment, Additional Resources

Document

Links to organisations involved in the fair treatment of employees, along with reference material.

Fair Treatment, Overview

Document

An introduction to the issue of harassment in the workplace.

Find an EHS Consultant

Link

The Premier Directory of Industrial Hygiene and Occupational and Environmental Health and Safety Consulting Professionals.

Flexible & Contained Transfer Solution for Powders

Document

"Flexible and Contained Transfer Solution for Small Powder Quantities" slideshow.

Flexible Containment Solutions

Document

"Flexible Containment Solutions" slideshow.

Flexible Materials

Document

Flexible Materials slideshow from the IH & Containment Conference.

Freedom of Association, Additional Resources

Document

Organisations and reference material relating to Freedom of Association.

Freedom of Association, Overview

Document

An introduction to the topic of Freedom of Association.

Freely Chosen Employment, Additional Resources

Document

Further information on Freely Chosen Employment (Organisations, Reference Material)

Freely Chosen Employment, Overview

Document

An introduction to freely chosen employment.

Freely Chosen Employment, What is Forced Labor?

Document

An explanation as to what Forced Labour is.

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

Fundamentals toxicology

Document

Fundamentals toxicology

General Hygiene Practices

Document

PowerPoint on good hygiene practices.

General Resources

Document

Resources including Organisations and Reference Material.

GHS - basic training

Document

Info session Globally Harmonized System of Classification and Labelling of chemicals

GHS - environmental hazards of substances

Document

Environmental hazards of substances

GHS - health hazards of substances

Document

Health hazards of substances

Global Environmental Management Initiative (GEMI) Tools

Link

A wide range of tools designed by GEMI to help companies improve the environment and provide business value.

Global Social Compliance Tool

Document

The Global Social Compliance Programme is a business‐driven programme for companies whose vision is to harmonise existing efforts in order to deliver a shared, global and sustainable approach for the continuous improvement of working and environmental conditions across categories and sectors in the global supply chain.

Good Work Practices PPE API

Document

Good Work Practices PPE API

Green Chemistry Pharma Week Photo Report

Document

Green Chemistry Pharma Week Photo Report February 2017

Group Code of Conduct

Document

The Roche Group Code of Conduct is designed to guide business behaviour and provides useful links to further information.

Guidelines for Process Safety Management - Mandarin Chinese

Document

Guidelines for process safety management of petrochemical corporations.

Handling Cytostatic Drugs

Link

Handling cytostatic drugs requires a number of organizational and technical systems in order to guarantee the best possible protection for personnel. This booklet focuses on various ways of protecting personnel from potential hazards through the careful handling of cytostatic drugs, and for this reason, product protection is only briefly discussed.

Handling Highly Potent Active Pharmaceutical Ingredients - Safebridge

Document

Equipment containment performance: Potent and highly potent active pharmaceutical ingredients have the potential to cause serious health effects in workers at very low airborne concentrations. The use of containment equipment as part of a systematic approach to potent compound safety is advised to control worker exposure. However the containment performance of equipment can not be assumed, evaluation of containment performance, using a standardised approach, should be adopted.

Handling of OEB-3

Document

"Handling of OEB-3" slideshow.

Hazard Communication Basics, 2013

Document

Slideshow concerning chemical hazard communication.

HMG Guidance on UK Bribery Act 2010

Link

Guidance about procedures which relevant commercial organisations can put into place to prevent persons associated with them from bribing.

Human Rights Position

Document

Example: Bayer's position on Human Rights and its commitments to implement them.

IH introduction training

Document

PowerPoint on the fundamentals of industrial hygiene.

IH Maturity Ladder ESI Sept 2011

Document

Conditions for sharing materials and advice - Excel

IH professional development tool

Document

IH professional development tool - guidance document.

ILO Combating Forced Labor: A Handbook for Employers & Business

Link

This sample checklist is designed for compliance personnel operating in companies or third party organisations providing services to companies. The aim of this checklist is to help compliance personnel perform better assessments.

Introduction basics IH and Maturity Ladder

Document

PowerPoint on "IH Maturity Ladder for EM".

Introduction presentation for PSCI audit opening meeting

Document

Introduction presentation for PSCI audit opening meeting

Introduction to the J&J IH maturity ladder

Document

IH & Containment Conference introduction to the J&J IH maturity ladder & tools.

Inventory chemical agents

Document

Chemical Substance Management - Inventory and Communication

Isolator Glovebox Maintenance Guideline

Document

The purpose of this document is to provide a methodology for the routine performance monitoring of non-aseptic Isolators or glove boxes used in the handling of hazardous compounds.

J&J Risk Based Exposure Assessment Process

Document

"The J&J Risk Based Exposure Assessment Process" slideshow from the IH & Containment Conference.

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.

K15 Directive - Dealing with Third Party Manufacturers

Document

The Roche Group Directive K15 concerning dealing with Third Party Manufacturers and Service Providers.

Lab Bureau Veritas IH Sampling Guide

Document

Lab Bureau Veritas IH Sampling Guide
Industrial Hygiene
Microscopy
Microbiology

Labeling and identification of hazardous substances

Document

Labeling and identification of hazardous substances and preparations

Labeling piping

Document

Chemical Hazard Communication: Labels piping

Labor - Overview and Management Systems

Document

Companies should use a management system to facilitate continual improvement and compliance with labor standards.

Laboratory Animal Allergy Program

Document

"Laboratory Animal Allergy Program" slideshow.

Labs - testing performance hoods isolators

Document

Testing Fume Hoods & Isolators
Chemical Production & Development site Geel
Michel Vangeel – EHS Department – October 2010

Material Safety Data Sheets (MSDS)

Document

Material Safety Data Sheets (MSDS)

Nitrogen Asphyxiation Bulletin Training Presentation

Document

Presentation on Nitrogen Asphyxiation.

Noise and hearing conservation

Document

"Noise and Hearing Conservation" PowerPoint.

Non-Discrimination, Additional Resources

Document

Further information on Non-Discrimination (Organisations, Reference Material).

Non-Discrimination, Overview

Document

An introduction to discrimination in the workplace.

Non-Discrimination, Roadmap

Document

A strategy for non-discrimination.

Non-Ionizing Radiation Safety Program

Document

The purpose of the non-ionizing radiation safety program is to ensure the safe use of Non-Ionizing Radiation (NIR) sources and to meet the expectations of the Standards.

Occupational Hygiene Exposure Verification

Document

"Occupational Hygiene Exposure Verification: Sampling and Interpretation" slideshow.

OSHA - Small Business Handbook

Link

This handbook is provided to owners, proprietors and managers of small businesses by the Occupational Safety and Health Administration (OSHA), an agency of the U.S. Department of Labor. It should help small business employers meet the legal requirements imposed by the Occupational Safety and Health Act of 1970 (the Act), and achieve an in-compliance status before an OSHA inspection.

Overview and Industrial Hygiene Management Systems

Document

An overview of Industrial hygiene and hazard assessment in the workplace.

Overview Containment Solution Guides

Document

This document contains an overview of the containment solution guides (CSGs) that are generated.

PBOEL 4 Handling

Document

PowerPoint on PBOEL4 Handling.

PBOEL Containment Technology

Document

PowerPoint from WWCP on Containment Technology.

Personal Protective Equipment - basic training

Document

"Personal Protective Equipment" PowerPoint

Physical Hazards

Document

Physical hazards are those hazards arising from work-related tasks as well as from the physical environment in which work is being performed.

Plastic Chemical and Condition Compatibility Chart

Document

This chart is provided as a general guide for plastic chemical and condition compatibility.

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.

Process Mass Intensity Calculation Tool

Link

The PMI Calculator enables you to quickly determine the PMI value by accounting for the raw material inputs and bulk API outputs of a process.

Updated Version - http://www.acs.org/content/dam/acsorg/greenchemistry/industriainnovation/roundtable/Convergent-PMI-Tool.xlsx

Process Mass Intensity Calculator Presentation

Link

The PMI Calculator enables you to quickly determine the PMI value by accounting for the raw material inputs and bulk API outputs of a process.

Updated Version - http://www.acs.org/content/dam/acsorg/greenchemistry/industriainnovation/roundtable/Convergent-PMI-Presentation.pptx

Process Safety

Document

Process Safety Management (PSM) is recognized as Good Manufacturing Practice. In many countries PSM is covered by specific regulations. The general intent of PSM is to provide safe processes that define and manage risk based on common management practice designed to identify and mitigate hazards.

PSCI 2018-2020 Strategy

Document

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

PSCI Anti-trust Statement EN CN

Document

PSCI Anti-trust Statement in English and Chinese

PSCI Articles of Incorporation

Document

PSCI Articles of Incorporation

PSCI Audit Sharing Plaform Supplier User Guide

Document

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.

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

PSCI Introductory Training for Auditors

Link

This PSCI webinar is a training video for auditors. This was recorded in September 2018.

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 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 Membership Agreement

Document

PSCI Membership Agreement. Last updated in 2017.

PSCI Membership Fees Structure

Document

This document explains the PSCI membership fees structure.

New version added: July 2018

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 Partnerships Strategy

Document 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).

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?

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.

PSCI Standard Operating Procedures

Document Members Only

PSCI Standard Operating Procedures

Version 5.0 added: July 2018

Qualitative Exposure Assessment

Document

Chemical Risk Assessment & Exposure Monitoring
Qualitative Chemical Risk Assessment

Qualitative Risk Assessment (API & Chemicals) RBEAC Guideline

Document

"Qualitative Risk Assessment (API & Chemicals) RBEAC Guideline" slideshow.

Quantitative Exposure Assessment

Document

Chemical Risk Assessment & Exposure Monitoring
Quantitative Risk Assessment

Quantitative Risk Assessment

Document

Quantitative Risk Assessment slideshow.

Radiation Resources

Document

Radiation Resources.

RBEAP API template

Document

Risk Based Exposure Assessment Process (RBEAP)

RBEAP instructions for use

Document

Guidelines and Instructions for Using Risk Based Exposure Assessment Process (RBEAP) Form

Objectives: To provide a tool and system that helps organize and document the decision for establishing an IH sampling strategy to assess risk.

RBEAP introduction

Document

Risk Based Exposure Assessment Process

RBEAP solvent template

Document

RBEAP solvent template

Respiratory Protection - overview

Document

"Respiratory Protection" - Overview.

Respiratory Protection - Written Program

Document

Written Respiratory Protection Program.

Respiratory Protection devices

Document

Respiratory Protection devices - Recommendations for selection, use, care and maintenance - Guidance Document.

Respiratory Protection Equipment at Work

Document

Respiratory protective equipment at work - A practical guide

Respiratory Protection program

Document

"Respiratory Protection program" power-point.

Responsible Sourcing Standards

Document

Novo Nordisk's Responsible Sourcing Programme. The standards are classified into six categories: general compliance with laws and regulations, health & safety, labour practices, ethics, environment, and sub-suppliers.

Risk identification model Flubendazole

Document

Risk identification model Flubendazole

Risk identification model IH

Document

Risk identification model IH

Risk identification model IH T1345

Document

Risk identification model IH T1345

Risk-Based Exposure Assessment & Control guideline

Document

Risk-Based Exposure Assessment & Control guideline

Risk-Based Exposure Assessment & Control guideline - first steps

Document

Risk-Based Exposure Assessment & Control guideline - first steps
Janssen
Johnson & Johnson

Safe Handling of New Molecular Entities

Document

Pharmaceutical Industry’s Approach to Safe Handling of New Molecular Entities.

Sample URS for Isolator Following Flow Chart - Functional Requirements Specification

Document

The purpose of this template is to assist in the preparation of the Functional Requirements Specifications (FRS) document for this system.

Sample URS for Isolator Following Flow Chart - User Requirements Specification

Document

The purpose of this template is to assist you in the preparation of the User Requirements Specification (URS) document for isolator systems.

Shared 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.

Solvent Selection Guide

Link

The ACS GCI Pharmaceutical Roundtable Solvent Selection Guide .

Update: Another selection guide (2015) has been published as a scientific paper. http://pubs.rsc.org/en/content/articlepdf/2016/gc/c5gc01008j

Specific Types of Forced Labor

Document

A list with explanations of the different types of forced labor.

Storage of chemicals - compatibility matrix

Document

Storage of chemicals - compatibility matrix

Storage of chemicals in laboratories - compatibility basic rules

Document

Storage of chemicals in laboratories - compatibility basic rules

Supplier Relations Charter

Document

The sanofi-aventis charter: The purpose of the Supplier Relationships Charter is to clarify the rules of conduct that must be respected by all Group collaborators in their relations with suppliers. The Charter supplements the Group’s Code of Ethics, in particular as concerns the Group’s image and reputation, integrity, ethical conduct and freedom from conflicts of interest. The Charter defines and sets Procurement rules of conduct that must be respected by all Group employees at all points of interaction with suppliers.

Sustainable Development Policy Example

Link

Bayer's sustainable development policy.

Tackling Child Labour - Danish Ethical Initiative

Link

Information on tackling child labour in Global Supply Chains from the Danish Ethical Trading Initiative.

Test webinar

Document Only

PSM !

Transparency International on Adequate Procedures

Link

The UK Bribery Act, which was passed in 2010, introduces an offence of corporate failure to prevent bribery. The defence for a company against this liability is to prove that it had adequate procedures in place to prevent bribery. This Guidance from Transparency International UK (TI-UK) is designed to assist companies to comply with the Bribery Act by providing clear, practical advice on good practice anti-bribery systems that in TI-UK's opinion constitute 'adequate procedures' for compliance with the Bribery Act.

UN Global Compact Supply Chain Guidance

Link

Multiple resources concerning the supply chain from UN Global Compact.

UNGC Fighting Corruption in the Supply Chain

Link

The UN Global Compact’s Fighting Corruption in the Supply Chain: A Guide for Customers and Suppliers outlines why businesses must join the fight against corruption and provides pragmatic advice on addressing this complex challenge.

UNICEF Resource on Child Labor Issues

Link

UNICEF Resource on Child Labor Issues

Verité Fair Hiring Toolkit for Businesses

Link

This Fair Hiring Toolkit offers tools, guidance, and approaches for businesses to support the responsible recruitment and hiring of migrant workers in global supply chains.

Verité Fair Hiring Toolkit for Suppliers

Link

This Fair Hiring Toolkit offers tools, guidance, and approaches for suppliers to support the responsible recruitment and hiring of migrant workers in global supply chains.

Wages, Benefits and Working Hours - Working Hours

Document

Information regarding employee working hours.

Wages, Benefits and Working Hours, Additional Resources

Document

Additional resources on wages, benefits and working hours.

Wages, Benefits and Working Hours, Overview

Document

An overview of employee wages, benefits and working hours.

Water Position

Document

An example is Bayer's “Science For A Better Life” where they promise innovative solutions to global economic, ecological and social challenges. The availability of fresh water is a growing concern around the world. Water is not only essential for life on earth but also for many industry sectors of the global economy and for us as a pharmaceutical and chemical company with energy and water intensive operations.

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

Video Link

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.

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 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.

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

Document

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.

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.

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.

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

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 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 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.

Worker Protection Overview

Document

Once the hazards in the workplace have been identified and categorized by type, location and degree, appropriate preventive and protective steps should be taken to deal with the hazards. Although Worker Protection is commonly equated to Personal Protective Equipment (PPE), PPE should actually be the last line of defence in the effort to protect workers.

Written Hearing Conservation Program

Document

This document has been developed as a program guideline for companies who are
required to have a written Hearing Conservation Program.

Written Respiratory Protection Program

Document

This respiratory protection program has been established to provide uniform and consistent procedures for those needing to wear respirators, either in the regular course of their duties or in emergencies. The program includes requirements for medical evaluation, training, and fit-testing of wearers; control of respirator selection, inspection, and maintenance; and recordkeeping. Standard operating procedures are included within, or attached to, this program.

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