• PDA TR 56

PDA TR 56

  • Technical Report No. 56 Revised 2016 (TR 56) Application of Phase-Appropriate Quality System and cGMP to the Development of Ther
  • Report / Survey by Parenteral Drug Association, 11/01/2016
  • Category: PDA

$325.00 $163.00

PDA's newly revised PDA Technical Report No. 56, Revised 2016 Application of Phase-Appropriate Quality System and cGMP to the Development of Therapeutic Protein Drug Substance provides an overview of the ideal state for broad good manufacturing practices (GMPs) throughout the product lifecycle and as they become more stringent from the discovery/R&D stage through Phase 3 clinical trials to commercial launch. This report also describes a basic framework for clinical trial manufacturing for sites where full commercial development and/or manufacturing may not be the organizational goal (e.g., university/grant-funded investigators, start-up biotech firms).
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PDA TR 77

PDA TR 77

Technical Report No. 77 (TR 77) The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-S..

$163.00 $325.00

PDA TR 60-2

PDA TR 60-2

Technical Report No. 60-2 (TR 60-2) Process Validation: A Lifecycle Approach, Annex 1: Oral Solid Do..

$163.00 $325.00

PDA TR 54-5

PDA TR 54-5

Technical Report No. 54-5 (TR 54-5) Quality Risk Management for the Design, Qualification, and Opera..

$163.00 $325.00

PDA TR 78

PDA TR 78

Technical Report No. 78 (TR 78) Particulate Matter in Oral Dosage Forms..

$163.00 $325.00