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.
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The Implementation Guidance Document provides examples of business practices and performance related to the Principles.
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 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.
Full presentation pack from the 2015 Supplier Conference held in Mumbai, India.
Day 1 presentation pack from the 2016 Supplier Conference held in Shanghai.
Day 2 presentation pack from the 2016 Supplier Conference held in Shanghai.
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.
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 Self Assessment Questionnaire & Audit Report Template for Service Providers & General Manufacturers.
Version 4, November 2016
Johnson & Johnson
Worldwide Health & Safety
Industrial Hygiene Analytical Method Development
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.
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
Basic principles ventilation part 2 - very hazardous substances
Industrial Hygiene Monitoring
Introduction To Bayesian Statistics
Dave Pearson, Djon Gentry, Tim Allers
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 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 arise from exposure to hormones, viruses, fungi, bacteria or any other living organisms that can cause harm, illness, or damage to the human body.
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 & Exposure Monitoring
Basic Elements / Characterisation
Links to additional resources including organisations involved in ending child labor and reference material.
An example of how to deal with child labor.
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.
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.
Example of a document produced after a fatality.
Industrial Hygiene FAT and SAT Performance Evaluation Protocol
"A CMO’s Journey to Higher Containment" slideshow.
PowerPoint from ISPE on controlling exposure to Active Pharmaceutical Agents.
ISPE slideshow concerning control of exposure to API in Chemical Production.
An example of Corporate Compliance Policy from Bayer.
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).
Chemical Risk Assessment & Exposure Monitoring Index - Consolidated
Examples decision trees to make up IH sampling plans