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Compliance Quiz: ICH Q9 and Q10

1. ICH is the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use and has been in process for:
2. The objective of the ICH is the technical and scientific harmonization of new chemical entities and biotechnology derived products produced in what countries?
3. Q9 and Q10 refer to guidelines on the following areas:
4. According to Q9, "The level of effort, formality and _________________ of the quality risk management process should be commensurate with the level of _______________."
5. Which are NOT listed in Q9 Annex II as potential applications for Quality Risk Management:
6. According to Q10 draft guidance on Pharmaceutical Quality Systems, the "product lifecycle" includes what technical activities pertaining to the "Manufacturing" of new and existing pharmaceutical products?
7. What is a CAPA?
8. According to Q10 draft guidance, "CAPA methodology should result in product and process _______________and enhanced product and process ______________."
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