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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The PSCI Principles

The PSCI Principles

Organisational Information
26 Nov 2019

The 2019 revision of the PSCI Principles (PSCI Principles v2.0) was approved by the membership on Tuesday 12th November, 2019, at the Annual General Meeting in Cambridge, Massachusetts.

The PSCI Principles for Responsible Supply Chain Management set the standard for human rights, ethics, labor, health and safety, environment and related management systems.The Principles may be voluntarily supported by any business in the pharmaceutical industry.

The Principles now include a specific reference to human rights and the UN Guiding Principles on Business and Human Rights, an enhanced ethics section, and new clauses on resource efficiency and sustainable sourcing.

The new version is currently available in English only. Translations will added in the coming weeks.

  • Ethics
  • Human Rights and Labor
  • Health & Safety
  • Environment
  • Management Systems

Full PSCI SAQ & Audit Report Template for Core Suppliers, External Manufacturers, Component and Material Suppliers (WORD VERSION)

Document
29 Jul 2019

MS Word version of the PSCI Self Assessment Questionnaire and Audit Report Template for Core Suppliers, External Manufacturers, Component and Material Suppliers.

Version 5, February 2019
Chinese translation added July 2019.

Select your preferred language from the options below
  • Ethics
  • Human Rights and Labor
  • Health & Safety
  • Environment
  • Management Systems
  • Audit Programme

Webinar slide deck: Antimicrobial Resistance

Slides
23 Jul 2019

This webinar initially aired on 18th July 2019

In this webinar we will be looking at the impact of pharmaceutical manufacturing on antimicrobial resistance, as well as demonstrating PSCI's PEC:PNEC calculator tool.

Our speakers will be covering the issues associated with antimicrobial drugs in wastewater, targets for environmental risk assessment of antimicrobial drugs, and how to assess the risk of antimicrobial drugs in wastewater.

We are delighted to be joined by the following speakers:

  • Daniel Caldwell, Global Director, Environmental and Occupational Toxicology at Johnson & Johnson;
  • Neil Parke, Global HSE Consultant at Lilly.
  • Pharmaceuticals In The Environment
  • Anti-Microbial Resistance

Webinar recording: Antimicrobial Resistance

Webinar Video Link
23 Jul 2019

This webinar initially aired on 18th July 2019

In this webinar we will be looking at the impact of pharmaceutical manufacturing on antimicrobial resistance, as well as demonstrating PSCI's PEC:PNEC calculator tool.

Our speakers will be covering the issues associated with antimicrobial drugs in wastewater, targets for environmental risk assessment of antimicrobial drugs, and how to assess the risk of antimicrobial drugs in wastewater.

We are delighted to be joined by the following speakers:

  • Daniel Caldwell, Global Director, Environmental and Occupational Toxicology at Johnson & Johnson;
  • Neil Parke, Global HSE Consultant at Lilly.
  • Pharmaceuticals In The Environment
  • Anti-Microbial Resistance

Consolidated PEC:PNEC Calculator Tool for assessing API discharges

Document
11 Jul 2019

This Excel spreadsheet tool provides instructions and guidance on how to assist pharmaceutical manufacturers in calculating how to meet predicted no effect concentration values (PNECs) for active pharmaceutical ingredients (APIs) discharged in wastewater from manufacturing operations.

  • Environment
  • Spills & Releases
  • Waste Management
  • Water Use & Management
  • Pharmaceuticals In The Environment
  • Anti-Microbial Resistance

Abbreviated PSCI SAQ & Audit Report Template for Service Providers & General Manufacturers (WORD VERSION)

Document
7 Feb 2019

WORD VERSION
Abbreviated PSCI Self Assessment Questionnaire & Audit Report Template for Service Providers & General Manufacturers.

Version 5, February 2019

  • Ethics
  • Human Rights and Labor
  • Health & Safety
  • Environment
  • Management Systems
  • Audit Programme

2018 China Supplier Conference Presentation Pack Day 1

Document
21 Sep 2018

Day 1 presentation pack from the 2018 Supplier Conference in Shanghai, China.

  • Ethics
  • Human Rights and Labor
  • Health & Safety
  • Environment
  • Management Systems
  • Pharmaceuticals In The Environment
  • Anti-Microbial Resistance

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

Slides
11 Jul 2018

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.

  • Environment
  • Pharmaceuticals In The Environment
  • Anti-Microbial Resistance

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

Webinar Video Link
11 Jul 2018

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.

  • Environment
  • Pharmaceuticals In The Environment
  • Anti-Microbial Resistance

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

Link
11 Jun 2018

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.
  • Pharmaceuticals In The Environment

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

Slides
26 Oct 2016

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.

  • Environment
  • Pharmaceuticals In The Environment

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

Webinar Video Link
20 Jun 2016

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
  • Environment
  • Pharmaceuticals In The Environment

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

Slides
20 Jun 2016

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
  • Environment
  • Pharmaceuticals In The Environment

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

Slides
3 Feb 2016

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.
  • Environment
  • Pharmaceuticals In The Environment

Webinar recording - managing APIs in manufacturing effluent - 27th Jan 2016

Webinar Video Link
3 Feb 2016

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.
  • Environment
  • Pharmaceuticals In The Environment

A risk based approach to managing APIs in manufacturing effluent

Document
20 Jan 2016

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.

  • Environment
  • Pharmaceuticals In The Environment

Find an EHS Consultant

Link
8 Jul 2015

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

  • Health & Safety
  • Environment

Best Management Practices for Leak and Spill Control

Document
7 Jul 2015

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.

  • Environment
  • Spills & Releases

Water Position

Document
7 Jul 2015

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.

  • Environment
  • Water Use & Management

Climate Change Position

Document
7 Jul 2015

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

  • Environment
  • Energy Use & Carbon Footprint

Global Environmental Management Initiative (GEMI) Tools

Link
7 Jul 2015

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

  • Environment

Process Mass Intensity Calculation Tool

Link
7 Jul 2015

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

  • Environment

Process Mass Intensity Calculator Presentation

Link
7 Jul 2015

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

  • Environment

Solvent Selection Guide

Link
7 Jul 2015

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

  • Environment
Guidance For Implementing The Principles

Guidance For Implementing The Principles

Document
24 Jun 2015

The Implementation Guidance Document provides examples of business practices and performance related to the Principles.

Select your preferred language from the options below
  • Ethics
  • Human Rights and Labor
  • Health & Safety
  • Environment
  • Management Systems

Environmental Handbook - Danish Environment Ministry

Document
1 Feb 2011

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.

  • Environment