Use different API in one production batch

Production
1

can be use different API supplier in same production batch ,and if accepted it can do for different dosage form?

2

Yes, please. We can use API lots of different suppliers in the same production batch provided they meet the following conditions,

  • Both the suppliers / manufacturers of API are qualified and approved by your QA unit.
  • Both the lots of API are approved by your QC Laboratory under one specification.
1 Like
3

thank for replying, is it require to do accelerated stability study for the finished product before release

4

Not required.

5

same understanding, examples that you are going to certain places, with possible transportation modes and you also can choose which class according to your budget. The most important you must arrive in time and well dressed according to protocols standard/ regulation

6

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