$162
PDA TR 54
2012
Technical Report No. 54 (TR 54) Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations
- Format:
- Language(s) :
- Published :
- English
- 03/01/2012
PCMOSM PDA Technical Report No. 54: Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations provides detailed guidance for the application and implementation of quality risk management (QRM) principles throughout the product lifecycle. Intended to align with ICH Q9 and present information that can be helpful to the reader on how to implement QRM, the report emphasizes QRM application during commercial manufacturing and integrating QRM into the pharmaceutical quality system.
| PDA TR 54 | |
|---|---|
| STANDARD INFO: | |
| Standard Name | PDA TR 54 |
| Scope | Technical Report No. 54 (TR 54) Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations |
| Publisher | PDA - Parenteral Drug Association |
| Languages | English |
| State | |
| Publication Year | 2012 |
| Most recent Version | MOST RECENT |
| Whether to be replaced | |
| Addendum | |
| FILE INFO: | |
| File Size | 1 file , 760 KB |
| ISBN(s) | 9780939459384 |
| Number of Pages | 61 |
| Product Code(s) | 01054 |
| Published | 03/01/2012 |
| PDA TR 54 | ||
|---|---|---|
| History | Publisher Year | |
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