RE: Testing on finished product Contribution from Richard Bonner written on 4/26/2005 at 10:40
Original contribution: Testing on finished product written by shekhar dabholkar on 4/7/2005 at 12:38) If there is a possibility that the filled product can be non-homogeneous, such as a suspension, powder formulation like a paediatric etc then the final testing would have to be on the filled pack. If however the final product is something like a tablet or capsule then the full analytical analysis can be carried out at the bulk stage and only an analytical identity carried out on the final pack. In both cases the QC person releasing the batch would need to satisfy themselves that they have the total data anlysis available to make their disposition decision.The sampling/testing plan for each batch needs to be documeneted. Stability testing of at least one lot of each final pack would also need to be run annually.
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