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.

Key Resources

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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.

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.

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.

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

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

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.

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

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.

CRA EM Index (Consolidated)

Document

Chemical Risk Assessment & Exposure Monitoring Index - Consolidated

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.

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.

Find an EHS Consultant

Link

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

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