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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Emergency Plan Template

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This template was produced by Aaron Duff, Director of EHS&S at Johnson & Johnson, and was showcased during the PSCI Webinar: Emergency Preparedness and Response on 27th June 2019.

Crisis Management Plan Template

Document

This template was produced by Aaron Duff, Director of EHS&S at Johnson & Johnson, and was showcased during the PSCI Webinar: Emergency Preparedness and Response on 27th June 2019.

Webinar slide deck: Emergency Preparedness and Response

Document

This webinar was initially aired on 27th June 2019

The webinar will give an overview of the questions relating to emergency preparedness & response in the PSCI audit questionnaire and explain the PSCI's expectations.

The webinar will focus on how to prepare a good site emergency response plan that covers the minimum requirements. You will also hear about the basic elements that should be considered when performing an impact assessment of neighboring industries on your site & vice versa.

We are delighted to be joined by the following speaker:
Aaron Duff, Director of EHS&S at Johnson & Johnson

Webinar recording: Emergency Preparedness and Response

Video Link

This webinar was initially aired on 27th June 2019

The webinar will give an overview of the questions relating to emergency preparedness & response in the PSCI audit questionnaire and explain the PSCI's expectations.

The webinar will focus on how to prepare a good site emergency response plan that covers the minimum requirements. You will also hear about the basic elements that should be considered when performing an impact assessment of neighboring industries on your site & vice versa.

We are delighted to be joined by the following speaker:
Aaron Duff, Director of EHS&S at Johnson & Johnson

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 5, February 2019

Chinese translation uploaded August 2019.

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 5, February 2019

Example RBEAP solvent

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Example RBEAP solvent

Example RBEAP API

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IH Air Monitoring Unit Risk Based Approach Decision Making

Radiation Resources

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Radiation Resources.

External H&S Resource Libraries

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External H&S Resource Libraries

Decision trees to make up IH sampling plans

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Examples decision trees to make up IH sampling plans

Respiratory Protection - Written Program

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Written Respiratory Protection Program.

Respiratory Protection Equipment at Work

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Respiratory protective equipment at work - A practical guide

Respiratory Protection program

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"Respiratory Protection program" power-point.

CRA EM Index (Consolidated)

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Chemical Risk Assessment & Exposure Monitoring Index - Consolidated

Respiratory Protection devices

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

Additive Effects Workshop 2 answer sheet

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Additive Effects Workshop 2 answer sheet

Additive Effects Workshop 2

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Additive Effects Workshop 2

Additive Effects Workshop 1 answer sheet

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Additive Effects Workshop 1 answer sheet

Additive Effects Workshop 1

Document

Additive Effects Workshop 1

Fundamentals toxicology

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Fundamentals toxicology

Example summary sheet Risperidone

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Example summary sheet Risperidone

IH Maturity Ladder ESI Sept 2011

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Conditions for sharing materials and advice - Excel

IH introduction training

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PowerPoint on the fundamentals of industrial hygiene.

IH professional development tool

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IH professional development tool - guidance document.

Nitrogen Asphyxiation Bulletin Training Presentation

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Presentation on Nitrogen Asphyxiation.

Example Accident Investigation - Dropped Panel Fatality

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Accident Investigation slideshow.

Handling of OEB-3

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"Handling of OEB-3" slideshow.

Contract Manufacturer's Journey to Higher Containment

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

Occupational Hygiene Exposure Verification

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

Introduction to the J&J IH maturity ladder

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

Hazard Communication Basics, 2013

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Slideshow concerning chemical hazard communication.

Overview Containment Solution Guides

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

Isolator Glovebox Maintenance Guideline

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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.

Engineering Controls for Exposure to APIs

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PowerPoint on engineering controls for exposure to active pharmaceutical ingredients.

GHS - health hazards of substances

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Health hazards of substances

GHS - environmental hazards of substances

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Environmental hazards of substances

Controlling Exposures to API in Chemical Production

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

Carcinogens, Hierarchy of Controls

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Best practices hierarchy of controls for carcinogens

Example Risk Analysis carcinogen acrylonitrile

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Example Risk Analysis carcinogen acrylonitrile

Control Banding

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Control Banding

Sample URS for Isolator Following Flow Chart - User Requirements Specification

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

Sample URS for Isolator Following Flow Chart - Functional Requirements Specification

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

Good Work Practices PPE API

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Good Work Practices PPE API

PBOEL Containment Technology

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PowerPoint from WWCP on Containment Technology.

Basic principles ventilation part 2 - very hazardous substances

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Basic principles ventilation part 2 - very hazardous substances

Basic principles ventilation

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Basic principles ventilation

Risk-Based Exposure Assessment & Control guideline - first steps

Document

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

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