Hello Everyone,
My company is a CMO that fills clinical trial parenterals. A few years ago, we implemented a process that requires ID testing for all incoming raw materials and pre-formulated BDS.
A new client has posed an interesting question about a possible alternative. We will be receiving their BDS, and the client has inquired about using temper seals in lieu of ID testing. We have heard some rumblings about other companies using this approach for early phase clinical trial material, however, we have been unable to find anything concrete.
Has anyone implemented a similar process? I know 21 CFR 210/211 is pretty explicit about ID testing, but I was curious if there was any flexibility with early phase material.
Thank you for the help!
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Adara Kurtz
Senior QA/RA Manager
Monument CO
United States
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