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Annex 7 (pages 285 - 309) of the "WHO Technical Report Series, No. 961, 2011" is entitled "WHO Guidelines on Transfer of Technology in Pharmaceutical Production". This document is of particular interest as, so far, there have been no concrete regulatory guidelines on this matter in Europe and the USA. Until now, only one document from the ISPE has provided recommendations on the topic. The new WHO document is intended to serve as a framework which can be applied in a flexible way rather than in a strict and rigid one. The introduction describes technology transfer as follows: "Technology transfer embodies both the transfer of documentation and the demonstrated ability of the receiving unit (RU) to effectively perform the critical elements of the transferred technology, to the satisfaction of all parties and any applicable regulatory bodies." Chapter 6 of the document focuses on analytical method transfer in quality control. Testing pharmaceutical products from starting materials to packaging components as well as samples for process validation or cleaning validation are examples of analytical methods. Table 1 is particularly interesting as it contains details regarding following testing methods: - Identity
- Assay for potency
- Content uniformity
- Dissolution
- Cleaning verification (i.e. swabbing samples)
- Microbiological testing (qualitative and quantitative)
- Impurities, degradation, residual solvents
For each testing method, you can find in the table following information: - Considerations for transfer
- Replication of tests (how many times should tests be repeated?)
- Set-up (definition of the comparative elements)
- Acceptance criteria (direct and statistically derived ones)
For example, the transfer of an assay for potency requires for 2 labs to have respectively 2 analysts testing 3 lots in triplicate, meaning in total 18 replications per site. Please see the Technical Report Series - Annex 7 for further information. Author:
Dr Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)
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