一期临床药品的放行

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However, in very limited circumstances and depending on the size and structure of an organization, all QC functions may be performed by the same individual(s) performing manufacturing.  For example, in some small operations, it may be necessary to have the same individual perform both manufact uring and QC functions, including  release or rejection of each batch.  However, in such circumstances, we strongly recommend that another qualified individual not involved in the manufacturing operation conduct an additional periodic review of manufacturing records and other QC activities.
When activities such as testing, commonly perf ormed by dedicated QC personnel in commercial manufacture, are performed by ma nufacturing personnel in phase 1 studies, adequate controls should be in place (e.g., segregation of testing  from manufacturing) so as to not contaminate testing or negatively affect test results.
选自《Guidance for Industry CGMP for Phase 1 Investigational Drugs 》

(Comment 24) One comment states that the guidance would allow the same person manufacturing the material (a non-QC unit employee) to also release the material to the clinic. The comment further states that the release of material by a non-member of the QC unit violates United States CGMP and a non-Qualified Person violates European Union CGMP, and does not appear to recognize the importance of having an experienced and knowledgeable unit or person to safely release the materials.
(Response) We agree with this comment in part. The companion guidance recognizes the need to have quality control in this early phase of clinical trial material manufacture and has provided recommendations for the quality control procedures that should be used. We provide flexibility for operations where a very small amount of clinical material is produced. While we agree that release of material by an untrained person violates United States CGMP, this is not what is recommended in the companion guidance, which indicates that, under very limited circumstances and where justified, only a person trained in CGMP and quality control functions should be given the dual responsibility of manufacture and release. The interpretation in the companion guidance is consistent with the quality unit functions under part 211 and the nature of commercial and investigational products.
选自：https://www.fda.gov/ohrms/dockets/98fr/oc07114.pdf

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