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 slide deck: Antimicrobial Resistance

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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.

Webinar recording: Antimicrobial Resistance

Video Link

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.

2019 China Supplier Conference : Agenda

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Agenda for the 2019 Supplier Conference held in Hangzhou, China.

Consolidated PEC:PNEC Calculator Tool for assessing API discharges

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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.

PSCI Overview Presentation

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Launched in August 2017. The deck summarises what the PSCI is and does and other useful information including the membership structure and how to join the initiative.

Updates:

  • Sept. 2017
  • Dec. 2017
  • Oct. 2018
  • Apr. 2019

PSCI Shared Audit Program Brochure

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This document gives a summary of the PSCI Shared Audit Program and process and answers frequently asked questions including:

  • Why do we audit?
  • What are "Shared" Audits?
  • Who benefits from Shared Audits?
  • Initiating a PSCI shared Audit
  • What happens in a PSCI Shared Audit?
  • Who carries out the audit?

Last updated July 2019

Data Sharing Agreement

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Supplier Data Sharing Agreement (updated June 2019)

Emergency Plan Template

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This template was produced by Aaron Duff, Director of EHS&S at Johnson & Johnson, and was showcased during the PSCI Webinar: Emergency Preparedness and Response on 27th June 2019.

Crisis Management Plan Template

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This template was produced by Aaron Duff, Director of EHS&S at Johnson & Johnson, and was showcased during the PSCI Webinar: Emergency Preparedness and Response on 27th June 2019.

Webinar slide deck: Emergency Preparedness and Response

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This webinar was initially aired on 27th June 2019

The webinar will give an overview of the questions relating to emergency preparedness & response in the PSCI audit questionnaire and explain the PSCI's expectations.

The webinar will focus on how to prepare a good site emergency response plan that covers the minimum requirements. You will also hear about the basic elements that should be considered when performing an impact assessment of neighboring industries on your site & vice versa.

We are delighted to be joined by the following speaker:
Aaron Duff, Director of EHS&S at Johnson & Johnson

Webinar recording: Emergency Preparedness and Response

Video Link

This webinar was initially aired on 27th June 2019

The webinar will give an overview of the questions relating to emergency preparedness & response in the PSCI audit questionnaire and explain the PSCI's expectations.

The webinar will focus on how to prepare a good site emergency response plan that covers the minimum requirements. You will also hear about the basic elements that should be considered when performing an impact assessment of neighboring industries on your site & vice versa.

We are delighted to be joined by the following speaker:
Aaron Duff, Director of EHS&S at Johnson & Johnson

PSCI Audit Guidance

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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.

PSCI Principles E-learning Tool

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This is a training tool for PSCI members and their suppliers on the PSCI principles.

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

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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.

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.

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

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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.

PSCI 2018-2020 Strategy

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This is a short summary of the new strategy, and the process taken to achieve it.

Webinar slide deck - Audit Programme Webinar, 4th Oct 2017

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Slides from the PSCI Audit Programme Webinar, Oct 2017
The webinar explained the supplier self-initiated audit model and launched the new Excel based audit templates.

PSCI Auditor Evaluation Tool

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This Excel template is designed to help PSCI members, suppliers and audit firms check auditors against the PSCI's requirements, to ensure that they have the expertise needed to conduct PSCI audits.

2017 India Conference Presentation Pack Day 2

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2017 India Conference Presentation Pack Day 2

2017 India Conference Presentation Pack Early Bird Dekra

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2017 India Conference Presentation Pack Early Bird Dekra
Chemical Hazard Assessment & Runaway Reactions

2017 India Conference Presentation Pack Early Bird PSCI Basics

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2017 India Conference Presentation Pack Early Bird PSCI Basics

2017 India Conference Presentation Pack Day 3

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2017 India Conference Presentation Pack Day 3

2017 India Conference Presentation Pack Day 1

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2017 India Conference Presentation Pack Day 1

2017 Supplier Conference Hyderabad, India, Agenda

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Agenda for 2017 Supplier Conference in Hyderabad, India

2016 China Supplier Conference Presentation Pack DAY 2

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Day 2 presentation pack from the 2016 Supplier Conference held in Shanghai.

2016 China Supplier Conference Presentation Pack DAY 1

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Day 1 presentation pack from the 2016 Supplier Conference held in Shanghai.

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

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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 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 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 1 - 27th Jan 2016

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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 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

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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

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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.

2015 India Supplier Conference Presentation Pack

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

2015 India Supplier Conference Brochure

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2015 India Supplier Conference Brochure

Pre-Audit Document Request List

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Pre-Audit Document Request List

Example RBEAP solvent

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Example RBEAP solvent

Example RBEAP API

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IH Air Monitoring Unit Risk Based Approach Decision Making

Radiation Resources

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Radiation Resources.

External H&S Resource Libraries

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External H&S Resource Libraries

Decision trees to make up IH sampling plans

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Examples decision trees to make up IH sampling plans

Respiratory Protection - Written Program

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Written Respiratory Protection Program.

Respiratory Protection Equipment at Work

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Respiratory protective equipment at work - A practical guide

Respiratory Protection program

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"Respiratory Protection program" power-point.

CRA EM Index (Consolidated)

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Chemical Risk Assessment & Exposure Monitoring Index - Consolidated

Respiratory Protection devices

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

Additive Effects Workshop 2 answer sheet

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Additive Effects Workshop 2 answer sheet

Additive Effects Workshop 2

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Additive Effects Workshop 2

Additive Effects Workshop 1 answer sheet

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Additive Effects Workshop 1 answer sheet

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