What is the GMP status of botanical raw materials (starting materials) in terms of compliance and inspection?
A18: Starting materials of botanical origin that are used to produce a botanical drug substance should be evaluated for quality. The use of appropriate starting materials and the drug substance manufacturer?s ability to control the source depend on appropriate specifications (tests, analytical procedures, and acceptance criteria). In addition to establishing specifications, manufacturers can achieve adequate quality control of starting materials by applying the principles outlined in FDA?s botanical guidance and by following good agricultural and good collection practice for starting materials of herbal origin (e.g., European Medicines Evaluation Agency HMPWP/31/99). Upon receipt of the starting materials at a processing facility, it is the responsibility of the drug substance manufacturer to determine the suitability of these raw materials before use. This can be accomplished by examining and/or testing to ensure that the acceptance criteria are met and by documenting the quality cont
