batch certificate
- Guideline or reference source
- HCGMP Canada GMP guidelines 2009
- Definition
- A certificate issued by the fabricator of a lot or batch of a drug that is exported within the framework of a mutual recognition agreement and in which the fabricator (a) identifies the master production document for the drug and certifies that the lot or batch has been fabricated, packaged/labelled and tested in accordance with the procedures described in that document; (b) provides a detailed description of the drug, including (i) a statement of all properties and qualities of the drug, including the identity, potency and purity of the drug, and (ii) a statement of tolerances for the properties and qualities of the drug; (c) identifies the analytical methods used in testing the lot or batch and provides details of the analytical results obtained; (d) sets out the addresses of the buildings at which the lot or batch was fabricated, packaged/labelled and tested; and (e) certifies that the lot or batch was fabricated, packaged/labelled and tested in accordance with the Good Manufacturing Practices of the regulatory authority that has recognized those buildings as meeting its Good Manufacturing Practices standard.” (C.01A.001) (The certificate’s content is also described in Appendix A).
- Related Term
- certification of the finished product batch
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