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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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.

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.

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.

PSCI Membership Fees Structure

Document

This document explains the PSCI membership fees structure.

New version added: July 2018

2015 India Supplier Conference Presentation Pack

Document

Full presentation pack from the 2015 Supplier Conference held in Mumbai, India.

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).

2015 India Supplier Conference Brochure

Document

2015 India Supplier Conference Brochure

Pre-Audit Document Request List

Document

Pre-Audit Document Request List

Example RBEAP solvent

Document

Example RBEAP solvent

Example RBEAP API

Document

IH Air Monitoring Unit Risk Based Approach Decision Making

Radiation Resources

Document

Radiation Resources.

External H&S Resource Libraries

Document

External H&S Resource Libraries

Decision trees to make up IH sampling plans

Document

Examples decision trees to make up IH sampling plans

Respiratory Protection - Written Program

Document

Written Respiratory Protection Program.

Respiratory Protection Equipment at Work

Document

Respiratory protective equipment at work - A practical guide

Respiratory Protection program

Document

"Respiratory Protection program" power-point.

CRA EM Index (Consolidated)

Document

Chemical Risk Assessment & Exposure Monitoring Index - Consolidated

Respiratory Protection devices

Document

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

Additive Effects Workshop 2 answer sheet

Document

Additive Effects Workshop 2 answer sheet

Additive Effects Workshop 2

Document

Additive Effects Workshop 2

Additive Effects Workshop 1 answer sheet

Document

Additive Effects Workshop 1 answer sheet

Additive Effects Workshop 1

Document

Additive Effects Workshop 1

Fundamentals toxicology

Document

Fundamentals toxicology

Example summary sheet Risperidone

Document

Example summary sheet Risperidone

IH Maturity Ladder ESI Sept 2011

Document

Conditions for sharing materials and advice - Excel

IH introduction training

Document

PowerPoint on the fundamentals of industrial hygiene.

IH professional development tool

Document

IH professional development tool - guidance document.

Nitrogen Asphyxiation Bulletin Training Presentation

Document

Presentation on Nitrogen Asphyxiation.

Example Accident Investigation - Dropped Panel Fatality

Document

Accident Investigation slideshow.

Handling of OEB-3

Document

"Handling of OEB-3" slideshow.

Contract Manufacturer's Journey to Higher Containment

Document

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

Occupational Hygiene Exposure Verification

Document

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

Introduction to the J&J IH maturity ladder

Document

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

Hazard Communication Basics, 2013

Document

Slideshow concerning chemical hazard communication.

Overview Containment Solution Guides

Document

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

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.

Engineering Controls for Exposure to APIs

Document

PowerPoint on engineering controls for exposure to active pharmaceutical ingredients.

GHS - health hazards of substances

Document

Health hazards of substances

GHS - environmental hazards of substances

Document

Environmental hazards of substances

Controlling Exposures to API in Chemical Production

Document

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

Carcinogens, Hierarchy of Controls

Document

Best practices hierarchy of controls for carcinogens

Example Risk Analysis carcinogen acrylonitrile

Document

Example Risk Analysis carcinogen acrylonitrile

Control Banding

Document

Control Banding

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.

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.

Good Work Practices PPE API

Document

Good Work Practices PPE API

PBOEL Containment Technology

Document

PowerPoint from WWCP on Containment Technology.

Basic principles ventilation part 2 - very hazardous substances

Document

Basic principles ventilation part 2 - very hazardous substances

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