Resources

Information on the 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.

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.

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

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

Version 4, November 2016

Additive Effects Workshop 1

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Additive Effects Workshop 1

Additive Effects Workshop 1 answer sheet

Document

Additive Effects Workshop 1 answer sheet

Additive Effects Workshop 2

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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

Analytical Methods

Document

Analytical Methods
Johnson & Johnson

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

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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

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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

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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

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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

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Example of a document produced after a fatality.

Containment Testing Protocol

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Industrial Hygiene FAT and SAT Performance Evaluation Protocol

Contract Manufacturer's Journey to Higher Containment

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

Control Banding

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Control Banding

Controlling exposures to API

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PowerPoint from ISPE on controlling exposure to Active Pharmaceutical Agents.

Controlling Exposures to API in Chemical Production

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

Corrective Action Plan Template

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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)

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Chemical Risk Assessment & Exposure Monitoring Index - Consolidated

Data Sharing Agreement

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Supplier Data Sharing Agreement (updated January 2017)

Decision trees to make up IH sampling plans

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Examples decision trees to make up IH sampling plans

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