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.
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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.
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.
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.
This document explains the PSCI membership fees structure.
New version added: July 2018
Full presentation pack from the 2015 Supplier Conference held in Mumbai, India.
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).
Examples decision trees to make up IH sampling plans
Respiratory protective equipment at work - A practical guide
Chemical Risk Assessment & Exposure Monitoring Index - Consolidated
Respiratory Protection devices - Recommendations for selection, use, care and maintenance - Guidance Document.
Excel IH Maturity Ladder ESI.
Excel Maturity Ladder ESI.
Presentation on Nitrogen Asphyxiation.
"A CMO’s Journey to Higher Containment" slideshow.
"Occupational Hygiene Exposure Verification: Sampling and Interpretation" slideshow.
IH & Containment Conference introduction to the J&J IH maturity ladder & tools.
This document contains an overview of the containment solution guides (CSGs) that are generated.
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.
PowerPoint on engineering controls for exposure to active pharmaceutical ingredients.
ISPE slideshow concerning control of exposure to API in Chemical Production.
Example Risk Analysis carcinogen acrylonitrile
The purpose of this template is to assist you in the preparation of the User Requirements Specification (URS) document for isolator systems.
The purpose of this template is to assist in the preparation of the Functional Requirements Specifications (FRS) document for this system.
Basic principles ventilation part 2 - very hazardous substances