$162
PDA TR 67
2014
Technical Report No. 67, (TR 67) Exclusion of Objectionable Microorganisms from Nonsterile Pharmaceuticals, Medical Devices, and Cosmetics
- Format:
- Language(s) :
- Published :
- English
- 10/01/2014
The purpose of TR 67 is to provide guidance to the nonsterile product manufacturing industry on how to manage the microbial risks associated with manufacturing and storage as well as how to determine what isolates would be deemed an objectionable microorganism in nonsterile products. This document is intended to be globally applicable. When country-specific regulations are cited, they are meant to serve as examples of such and are not binding to the industry stakeholders outside the country's jurisdiction. The absence of a list of objectionable microorganisms from this technical report acknowledges that the manufacturer of the product has all of the variable information, about a product and its intended use, needed to make an informed decision regarding the product's disposition. This belief is consistent with the U.S. cGMP regulations, which assign the responsibility for excluding objectionable microorganisms specifically to the manufacturer.
| PDA TR 67 | |
|---|---|
| STANDARD INFO: | |
| Standard Name | PDA TR 67 |
| Scope | Technical Report No. 67, (TR 67) Exclusion of Objectionable Microorganisms from Nonsterile Pharmaceuticals, Medical Devices, and Cosmetics |
| Publisher | PDA - Parenteral Drug Association |
| Languages | English |
| State | |
| Publication Year | 2014 |
| Most recent Version | MOST RECENT |
| Whether to be replaced | |
| Addendum | |
| FILE INFO: | |
| File Size | 1 file , 1000 KB |
| ISBN(s) | 9780939459704 |
| Number of Pages | 70 |
| Product Code(s) | 01067 |
| Published | 10/01/2014 |
| PDA TR 67 | ||
|---|---|---|
| History | Publisher Year | |
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