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

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.

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.

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

Best Management Practices for Leak and Spill Control

Document

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.

Climate Change Position

Document

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.

http://www.novonordisk.com/about-novo-nordisk/novo-nordisk-in-brief/positions/climate-change.html

Environmental Handbook - Danish Environment Ministry

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A practical handbook for suppliers and sub-suppliers on good environmental practices, prepared by the Danish Ethical Trading Initiative (DIEH) in cooperation with COWI and the Danish Federation of Small and Medium-Sized Enterprises as part of a joint project between DIEH and the Danish Environmental Protection Agency.

Find an EHS Consultant

Link

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

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 4, November 2016

Global Environmental Management Initiative (GEMI) Tools

Link

A wide range of tools designed by GEMI to help companies improve the environment and provide business value.

Predicted-No-Effect-Concentration (PNEC) resource links

Link

The following are useful resources for obtaining PNEC values.

  1. AMR Industry Alliance Antibiotic Discharge Targets - List of Predicted No-Effect Concentrations (PNECs).
    The PNEC table contains two values, PNEC‐Environment (PNEC‐ENV) values based on eco-toxicology and PNEC‐Minimum Inhibitory Concentration (PNEC‐MIC) values intended to be protective of resistance promotion.
    The AMR Industry Alliance recommendation is that companies target the lower of these two values (when available) for assessing manufacturing site discharges under a risk‐based framework.

  2. Temple WET Center PNEC database where you will find PNEC values for APIs other than antibiotics.

Process Mass Intensity Calculation Tool

Link

The PMI Calculator enables you to quickly determine the PMI value by accounting for the raw material inputs and bulk API outputs of a process.

Updated Version - http://www.acs.org/content/dam/acsorg/greenchemistry/industriainnovation/roundtable/Convergent-PMI-Tool.xlsx

Process Mass Intensity Calculator Presentation

Link

The PMI Calculator enables you to quickly determine the PMI value by accounting for the raw material inputs and bulk API outputs of a process.

Updated Version - http://www.acs.org/content/dam/acsorg/greenchemistry/industriainnovation/roundtable/Convergent-PMI-Presentation.pptx

Solvent Selection Guide

Link

The ACS GCI Pharmaceutical Roundtable Solvent Selection Guide .

Update: Another selection guide (2015) has been published as a scientific paper. http://pubs.rsc.org/en/content/articlepdf/2016/gc/c5gc01008j

Water Position

Document

An example is Bayer's “Science For A Better Life” where they promise innovative solutions to global economic, ecological and social challenges. The availability of fresh water is a growing concern around the world. Water is not only essential for life on earth but also for many industry sectors of the global economy and for us as a pharmaceutical and chemical company with energy and water intensive operations.

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.

Webinar recording - managing APIs in manufacturing effluent Part 2 - 15th June 2016

Link

This is recording of the PSCI sponsored webinar on how to manage APIs in manufacturing effluent (Part 2) which took place on 15th June 2016. The webinar provided step-by-step guidance on this ‘spotlight’ issue for our industry and covered the following topics:

  • estimating actual API losses from the manufacturing process (PEC)
  • establishing the acceptable discharge concentration (PNEC)
  • making low capital investment housekeeping steps to reduce the loss of APIs

Webinar recording - managing APIs in manufacturing effluent Part 4 - 10th July 2018

Link

This is recording of the PSCI sponsored webinar on how to manage APIs in manufacturing effluent (Part 4) which took place on 10th July 2018.

The webinar gave a brief refresher on Pharmaceuticals in the Environment (PiE), Anti-Microbial Resistance (AMR) and Predicted No-Effect Concentration (PNEC) first principles, and introduced a PSCI resource page where PNECs can be found. It also included step-by-step guidance on how to locate PNECs and use them.

Webinar slide deck - managing APIs in manufacturing effluent Part 1 - 27th Jan 2016

Document

This is the slide deck for 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.

Webinar slide deck - managing APIs in manufacturing effluent Part 2 - 15th June 2016

Document

This is the slide deck for the PSCI sponsored webinar on how to manage APIs in manufacturing effluent (Part 2) which took place on 15th June 2016. The webinar provided step-by-step guidance on this ‘spotlight’ issue for our industry and covered the following topics:

  • estimating actual API losses from the manufacturing process (PEC)
  • establishing the acceptable discharge concentration (PNEC)
  • making low capital investment housekeeping steps to reduce the loss of APIs

Webinar slide deck - managing APIs in manufacturing effluent Part 3 - 25th October 2016

Document

This is the slide deck for the PSCI sponsored webinar on how to manage APIs in manufacturing effluent (Part 3) which took place on 25th October 2016. The webinar looked at advanced technologies to reduce API loss with guest speakers from the Temple University WET Centre and AECOM.

Webinar slide deck - managing APIs in manufacturing effluent Part 4 - 10th July 2018

Document

This is the slide deck from the PSCI sponsored webinar on how to manage APIs in manufacturing effluent (Part 4) which took place on 10th July 2018.

The webinar gave a brief refresher on Pharmaceuticals in the Environment (PiE), Anti-Microbial Resistance (AMR) and Predicted No-Effect Concentration (PNEC) first principles, and introduced a PSCI resource page where PNECs can be found. It also included step-by-step guidance on how to locate PNECs and use them.