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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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.

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