Can API and excipients be used in drug product engineering batches using API supplier CoA results or should the API and excipients be analysed and released using methods fully qualified by the engineering batch drug product manufacturer laboratory?
It is necessary to analyse and release the API and excipients to be used in the manufacturing of engineering batches of the drug product. The quality of API and excipients should not be relied on the API/excipient supplier COAs. Moreover, the analytical methods used to analyze API and excipients should be validated in accordance with ICH guidelines.
Subsequent batches of the drug product may be manufactured using API and excipients based on suppliersā COAs. The suppliersā COAs are validated by performing a complete analysis of the API and excipients as per specifications and validated analytical methods. The analytical results obtained from in-house analysis and the analytical results from the COAs (API and excipients) of suppliers should be comparable. This should be done periodically to assess the reliability of suppliersā COAs.
Q: Can API and excipients be used in drug product engineering batches using API supplier CoA results or should the API and excipients be analysed and released using methods fully qualified by the engineering batch drug product manufacturer laboratory?
A: Its cGMP requirement as every CPP, CQA linkage process, excipients, product must be IH release so its linkage would facilitate whenever required. Main rational for this is product characteristic during development must be known for formulator.
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