$162
PDA TR 58
2012
Technical Report No. 58 (TR 58) Risk Management for Temperature-Controlled Distribution
- Format:
- Language(s) :
- Published :
- English
- 09/01/2012
PDA Technical Report No. 58: Risk Management for Temperature-Controlled Distribution is meant to complement ICH Q9: Quality Risk Management, and is part of the series of good distribution technical reports produced by the PDA Pharmaceutical Cold Chain Interest Group, which has developed Technical Reports No. 39 (Cold Chain), 46 (Last Mile), 52 (GDPs) and 53 (Stability Testing). The goals of risk management in the temperature-controlled distribution of pharmaceutical products, are to:
- Preserve the quality, safety and efficacy of the product
- Understand the distribution process
- Reduce risk
- Understand residual risk
- Improve the effectiveness of the process
Technical Report No. 58 provides specific guidance on the identification, assessment, evaluation, control and review of risks in the distribution process, such as receipt, storage, handling and shipping of bulk, intermediate and finished pharmaceuticals, biological medicinal products and medical devices. It also provides guidance for handling incidents, like temperature excursions, that occur during the distribution process. The Appendix includes examples of five executed FMEAs for the distribution of products in temperature-controlled containers and thermal packouts and a description of Incoterm definitions.
| PDA TR 58 | |
|---|---|
| STANDARD INFO: | |
| Standard Name | PDA TR 58 |
| Scope | Technical Report No. 58 (TR 58) Risk Management for Temperature-Controlled Distribution |
| 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 , 1000 KB |
| ISBN(s) | 9780939459438 |
| Number of Pages | 73 |
| Product Code(s) | 01058 |
| Published | 09/01/2012 |
| PDA TR 58 | ||
|---|---|---|
| History | Publisher Year | |
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