certificate of manufacture
- Guideline or reference source
- HCGMP Canada GMP guidelines 2009
- Definition
- A document issued by a vendor to a distributor or importer that attests that a specific lot or batch of drug has been produced in accordance with its master production documents. Such certificates include a detailed summary of current batch documentation, with reference to respective dates of revision, manufacture, and packaging, and are signed and dated by the vendor’s quality control department. For drugs that are fabricated, packaged/labelled and tested in MRA countries, the batch certificate is considered to be equivalent.
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