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).
Document identifier
PDA TR 56
Title
Technical Report No. 56 Revised 2016 (TR 56) Application of Phase-Appropriate Quality System and cGMP to the Development of Therapeutic Protein Drug Substance (API or Biological Active Substance)
Publication date
2016-11-01
International Relationship
| Price |
325 vnd |
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