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Here is a short-list of the most recent Technical Reports:

• PDA Technical Report No. 54-5 (TR 54-5) Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems

  This Technical Report provides practical guidance on how to manage quality risks throughout the manufacturing system lifecycle and illustrates concepts through two case studies.
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• PDA Technical Report No. 60-2 (TR 60-2) Process Validation: A Lifecycle Approach, Annex 1: Oral Solid Dosage/Semisolid Dosage Forms

  This document builds on and illustrates how concepts from TR 60 can be applied to oral solid dosage and semisolid dosage drug products, so that the reader can gain a clear understanding of the application of the process validation lifecycle to these technologies.
  Table of Contents

• PDA Technical Report No. 77 (TR 77) The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology

  This document provides recommendations specific to the operation of blow-fill-seal (BFS) technology for the manufacture of sterile pharmaceuticals (e.g., ophthalmic, parenteral, and inhalation). The intent of this document is to provide supplemental information to assist the user with interpretation of international standards and regulatory guidance from the perspective of BFS operations.
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• PDA Technical Report No. 56, Revised 2016, (TR 56) Application of Phase-Appropriate Quality Systems and cGMP to the Development of Therapeutic Protein Drug Substance (API or Biological Active Substance)

  This document provides an overview of the ideal state for broad good manufacturing practices throughout the product lifecycle and as they become more stringent from the discovery/R&D stage through Phase 3 clinical trials to commercial launch
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• Technical Report No. 76, Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging

  This document offers consistent and standardized quality criteria that can be used by pharmaceutical and medical device manufacturers for the visual inspection of incoming elastomeric components and aluminum seals, and by suppliers for outgoing inspection
  Table of Contents