$162
PDA TR 56
2016
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)
- Format:
- Language(s) :
- Published :
- English
- 11/01/2016
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).
| PDA TR 56 | |
|---|---|
| STANDARD INFO: | |
| Standard Name | PDA TR 56 |
| Scope | 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) |
| Publisher | PDA - Parenteral Drug Association |
| Languages | English |
| State | |
| Publication Year | 2016 |
| Most recent Version | MOST RECENT |
| Whether to be replaced | |
| Addendum | |
| FILE INFO: | |
| File Size | 1 file , 670 KB |
| ISBN(s) | 9780939459933 |
| Number of Pages | 36 |
| Product Code(s) | 01056 |
| Published | 11/01/2016 |
| PDA TR 56 | ||
|---|---|---|
| History | Publisher Year | |
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