What information should be provided when there are multiple sources for a starting material?

刊登日期:2020-07-22  |  點閱次數 : 1092 次 

The following information should be provided:

  1. 1. Name and address of each starting material manufacturer.
  2. 2. The synthetic route or process flow diagram of each starting material manufacturer should be provided if the starting material is not a commercial available chemical compound. Synthetic route and process flow diagram should include information such as reagents, catalysts and solvents used in the starting material manufacturing process.
  3. 3. As mentioned above, impurity profiles of starting material should be evaluated with regard to different manufacturing processes used by starting material manufacturers in order to justify the suitability of the starting material specification in controlling impurities in the starting material.
  4. 4. Justification of starting material specification should be provided based on evaluation of different synthesis routes used by the starting material manufacturers and different residual impurities associated with different synthesis routes.
  5. 5. Certificates of Analyses (CoAs) of starting material manufacturers and corresponding in-house analysis reports of starting materials should be provided.
  6. 6. Analysis results of drug substance batches manufactured using starting materials from different sources should be provided in order to demonstrate that drug substance quality remains consistent when starting materials from different sources are used.


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