WHO: New Technical Report (TRS 1060) Published
The WHO has released a series of new and updated guidelines related to pharmaceutical manufacturing, testing, and development, published as part of Technical Report Series No. 1060 (TRS 1060). Annexes 2 through 9 address a range of topics, including nitrosamine control, GMP for excipients, bioanalytical methods and blood establishments.
The following appendices are relevant to GMP:
- Annex 2: WHO good practice considerations for the prevention and control of nitrosamines in pharmaceutical products – new
- Annex 3: WHO good manufacturing practices for excipients used in pharmaceutical products – new: Appendix 1 and 2 (risk management and list of examples of high-risk excipients and contaminants)
- Annex 4: Good practices for blood establishments – updated
- Annex 6: Guideline on bioanalytical method validation and study sample analysis – new
Source:
WHO: WHO Expert Committee on Specifications for Pharmaceutical Preparations, 58th Report
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