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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2018 Supplier Conference Shanghai, China, Agenda

Agenda
26 Jul 2018

This is the agenda for 2018 PSCI China Supplier Conference.

Select your preferred language from the options below

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

PSCI Member Audit Sharing Target

Document
11 Jul 2018

This document defines the PSCI member audit sharing target.
Approved by the PSCI Board in May 2018.
Applicable from January 2019.

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
PSCI Inaugural Annual Report 2017 / 2018

PSCI Inaugural Annual Report 2017 / 2018

Document
19 Mar 2018

Inside the report, you will find highlights and achievements from 2017, a busy and important year for PSCI, and our plans for 2018.

PSCI 2018-2020 Strategy

Document
17 Jan 2018

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

PSCI Membership Types

Organisational Information
30 Nov 2017

This document outlines the criteria, responsibilities and benefits of the two PSCI membership types - Full and Associate

New version added: July 2018

PSCI Auditor Training 2017 Shanghai (Day 1)

Document
22 Nov 2017

Presentation Pack from the 2017 PSCI Auditor Training, 20 - 22 November, in Shanghai, China.

  • Audit Programme

PSCI Auditor Training 2017 Shanghai (Day 2)

Document
22 Nov 2017

Presentation Pack from the 2017 PSCI Auditor Training, 20 - 22 November, in Shanghai, China.

  • Audit Programme

PSCI Auditor Training 2017 Shanghai (Day 3)

Document
22 Nov 2017

Presentation Pack from the 2017 PSCI Auditor Training, 20 - 22 November, in Shanghai, China.

  • Audit Programme

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

Slides
5 Oct 2017

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

Document
26 Sep 2017

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.

  • Audit Programme

PSCI Membership Agreement

Organisational Information
12 Sep 2017

PSCI Membership Agreement. Last updated in 2017.

PSCI Articles of Incorporation

Organisational Information
12 Sep 2017

PSCI Articles of Incorporation

PSCI Bylaws

Organisational Information
12 Sep 2017

Bylaws of the Pharmaceutical Supply Chain Initiative. Last updated in Feb 2017.

2017 India Conference Presentation Pack Day 2

Slides
19 May 2017

2017 India Conference Presentation Pack Day 2

2017 India Conference Presentation Pack Early Bird Dekra

Slides
19 May 2017

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

2017 India Conference Presentation Pack Early Bird PSCI Basics

Slides
19 May 2017

2017 India Conference Presentation Pack Early Bird PSCI Basics

2017 India Conference Presentation Pack Day 3

Slides
19 May 2017

2017 India Conference Presentation Pack Day 3

2017 India Conference Presentation Pack Day 1

Slides
19 May 2017

2017 India Conference Presentation Pack Day 1

2017 Supplier Conference Hyderabad, India, Agenda

Agenda
30 Mar 2017

Agenda for 2017 Supplier Conference in Hyderabad, India

Green Chemistry Pharma Week Photo Report

Document
20 Mar 2017

Green Chemistry Pharma Week Photo Report February 2017

PSCI Auditor Training 2017 Hyderabad

Document
20 Mar 2017

Presentation booklet from the 2017 PSCI Auditor Training, 28 Feb - 1 March, in Hyderabad, India

  • Audit Programme

PSCI CAPR template in Excel format

Document
21 Feb 2017

PSCI CAPR template in Excel format

  • Audit Programme

PSCI Auditor Training 2015

Document
14 Feb 2017

PSCI Auditor Training presentation deck from 2015

  • Audit Programme

2016 China Supplier Conference Presentation Pack DAY 2

Slides
30 Nov 2016

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

2016 China Supplier Conference Presentation Pack DAY 1

Slides
30 Nov 2016

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

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

PSCI Social Media Guide for Members

Organisational Information
24 Feb 2016

This social media guide aims to raise the profile of PSCI members on LinkedIn and Twitter, the 2 social networks which are part of our marketing communications strategy.

It outlines the key actions that members can take to boost the profile of PSCI on LinkedIn and Twitter.

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

PSCI Audit Sharing Plaform Supplier User Guide

Document
1 Feb 2016

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.

  • Audit Programme

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

PSCI Membership Fees Structure

Organisational Information
6 Jan 2016

This document explains the PSCI membership fees structure.

New version added: July 2018

2015 India Supplier Conference Presentation Pack

Slides
14 Oct 2015

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

Corrective Action Plan Template

Document
13 Oct 2015

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).

  • Audit Programme

2015 India Supplier Conference Brochure

Document
9 Sep 2015

2015 India Supplier Conference Brochure

Pre-Audit Document Request List

Document
3 Aug 2015

Pre-Audit Document Request List

  • Audit Programme

Example RBEAP solvent

Document
10 Jul 2015

Example RBEAP solvent

  • Health & Safety
  • Occupational Health & Industrial Hygiene

Example RBEAP API

Document
10 Jul 2015

IH Air Monitoring Unit Risk Based Approach Decision Making

  • Health & Safety
  • Occupational Health & Industrial Hygiene

Radiation Resources

Document
10 Jul 2015

Radiation Resources.

  • Health & Safety
  • Hazard Information

External H&S Resource Libraries

Document
10 Jul 2015

External H&S Resource Libraries

  • Health & Safety

Decision trees to make up IH sampling plans

Document
10 Jul 2015

Examples decision trees to make up IH sampling plans

  • Health & Safety
  • Occupational Health & Industrial Hygiene

Respiratory Protection - Written Program

Document
10 Jul 2015

Written Respiratory Protection Program.

  • Health & Safety
  • Worker Protection

Respiratory Protection Equipment at Work

Document
10 Jul 2015

Respiratory protective equipment at work - A practical guide

  • Health & Safety
  • Worker Protection

Respiratory Protection program

Document
10 Jul 2015

"Respiratory Protection program" power-point.

  • Health & Safety
  • Worker Protection

CRA EM Index (Consolidated)

Document
10 Jul 2015

Chemical Risk Assessment & Exposure Monitoring Index - Consolidated

  • Health & Safety
  • Occupational Health & Industrial Hygiene
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