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

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Noise and hearing conservation

Document

"Noise and Hearing Conservation" PowerPoint.

Non-Discrimination, Additional Resources

Document

Further information on Non-Discrimination (Organisations, Reference Material).

Non-Discrimination, Overview

Document

An introduction to discrimination in the workplace.

Non-Discrimination, Roadmap

Document

A strategy for non-discrimination.

Non-Ionizing Radiation Safety Program

Document

The purpose of the non-ionizing radiation safety program is to ensure the safe use of Non-Ionizing Radiation (NIR) sources and to meet the expectations of the Standards.

Occupational Hygiene Exposure Verification

Document

"Occupational Hygiene Exposure Verification: Sampling and Interpretation" slideshow.

OSHA - Small Business Handbook

Link

This handbook is provided to owners, proprietors and managers of small businesses by the Occupational Safety and Health Administration (OSHA), an agency of the U.S. Department of Labor. It should help small business employers meet the legal requirements imposed by the Occupational Safety and Health Act of 1970 (the Act), and achieve an in-compliance status before an OSHA inspection.

Overview and Industrial Hygiene Management Systems

Document

An overview of Industrial hygiene and hazard assessment in the workplace.

Overview Containment Solution Guides

Document

This document contains an overview of the containment solution guides (CSGs) that are generated.

PBOEL 4 Handling

Document

PowerPoint on PBOEL4 Handling.

PBOEL Containment Technology

Document

PowerPoint from WWCP on Containment Technology.

Personal Protective Equipment - basic training

Document

"Personal Protective Equipment" PowerPoint

Physical Hazards

Document

Physical hazards are those hazards arising from work-related tasks as well as from the physical environment in which work is being performed.

Plastic Chemical and Condition Compatibility Chart

Document

This chart is provided as a general guide for plastic chemical and condition compatibility.

Pre-Audit Document Request List

Document

Pre-Audit Document Request List

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

Process Safety

Document

Process Safety Management (PSM) is recognized as Good Manufacturing Practice. In many countries PSM is covered by specific regulations. The general intent of PSM is to provide safe processes that define and manage risk based on common management practice designed to identify and mitigate hazards.

PSCI 2018-2020 Strategy

Document

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

PSCI Anti-trust Statement EN CN

Document

PSCI Anti-trust Statement in English and Chinese

PSCI Articles of Incorporation

Document

PSCI Articles of Incorporation

PSCI Audit Sharing Plaform Supplier User Guide

Document

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.

PSCI Audit Sharing Platform Member User Guide

Document

This PSCI Audit Sharing Platform User Guide explains how to use the Audit Sharing Platform for members. 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.

PSCI Audit Sharing Platform Member User Guide Training Video

Video Link Members Only

This is a Training Video on how to navigate the PSCI Audit Sharing Platform for member users. The video is split into 4 parts as shown below:

  1. How to access the Platform (0:00 – 04:38)
  2. The Suppliers List (04:38 – 11:39)
  3. Suppliers pages; how to see and upload Audits, SAQs and CAPRs (11:40 – 20:24)
  4. The new SAQ and Audit lists (20:25 – end)

For further assistance please refer to the Member User Guide or contact us at info@pscintiative.org.

PSCI Auditor Evaluation Tool

Document

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.

PSCI Auditor Training 2015

Document

PSCI Auditor Training presentation deck from 2015

PSCI Auditor Training 2017 Hyderabad

Document

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

PSCI Auditor Training 2017 Shanghai (Day 1)

Document

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

PSCI Auditor Training 2017 Shanghai (Day 2)

Document

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

PSCI Auditor Training 2017 Shanghai (Day 3)

Document

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

PSCI Branding Guidelines

Document

PSCI Branding Guidelines

PSCI Bylaws

Document

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

PSCI CAPR template in Excel format

Document

PSCI CAPR template in Excel format

PSCI Introductory Training for Auditors

Link

This PSCI webinar is a training video for auditors. This was recorded in September 2018.

PSCI Member Application Flow Chart

Document Only

This document outlines the process that PSCI follows to review and approve (or not) new member applications.

PSCI Member Audit Sharing Target

Document

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

PSCI Membership Agreement

Document

PSCI Membership Agreement. Last updated in 2017.

PSCI Membership Fees Structure

Document

This document explains the PSCI membership fees structure.

New version added: July 2018

PSCI Membership Types

Document

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

New version added: July 2018

PSCI Partnerships Strategy

Document Only

PSCI engages with a wide range of organisations and individuals in a variety of partnership arrangements. In the PSCI Strategy 2018-2020, we dedicated a Strategic Objective to building external partnerships (Strategic Objective 3.1). Strengthening our approach to Partnerships will be an important theme over the next two-three years to help us achieve our vision to establish and promote responsible practices that will continuously improve social, health, safety and environmentally sustainable outcomes for member supply chain.

This strategy formalises PSCI's approach to partnerships. It explains what we look for from partners and who we partner with (pages 2-3), the PSCI partnering process (pages 3-6), and how we work with partners once the relationship is established (page 7).

PSCI Shared Audit Program Brochure

Document

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?

PSCI Social Media Guide for Members

Document

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.

PSCI Standard Operating Procedures

Document Members Only

PSCI Standard Operating Procedures

Version 5.0 added: July 2018

Qualitative Exposure Assessment

Document

Chemical Risk Assessment & Exposure Monitoring
Qualitative Chemical Risk Assessment

Qualitative Risk Assessment (API & Chemicals) RBEAC Guideline

Document

"Qualitative Risk Assessment (API & Chemicals) RBEAC Guideline" slideshow.

Quantitative Exposure Assessment

Document

Chemical Risk Assessment & Exposure Monitoring
Quantitative Risk Assessment

Quantitative Risk Assessment

Document

Quantitative Risk Assessment slideshow.

Radiation Resources

Document

Radiation Resources.

RBEAP API template

Document

Risk Based Exposure Assessment Process (RBEAP)

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