PDA Technical Report No. 54-6 (TR 54-6) Formalized Risk Assessment for Excipients (single user digital version)

Dec 2019
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PDA Technical Report No. 54-6, Risk Assessment for Excipients, is the sixth technical report (TR) in the TR 54 series related to various aspects of Quality Risk Management (QRM). It was developed to provide additional guidance on the excipient risk assessment process required by the European Commission Guidelines on the formalized risk assessment for ascertaining the appropriate GMP for excipients of medicinal products for human use and incorporated into the PIC/S publication of the same name. The information in TR 54-6 applies to all excipients used in drug products for human use at all stages of the product lifecycle.

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Table of Contents

Table of Contents:

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  1. Introduction
  2. Glossary and Abbreviations
  3. Overall Strategy - A Holistic View
  4. Supply Chain - End to End
  5. Different Roles in the Supply Chain and Information-Gathering
  6. A Model for Quality Risk Management for Excipients
  7. Ongoing Review - Formalized Risk Assessment Lifecycle
  8. Benefits and Value/QRM/Knowledge Management
  9. References
  10. Annex 1: Real World Examples of Risk Assessments
  11. References (For Annex 1)

Figures and Tables Index