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KSM usage in process validation

Contribution from vasks written on 4/18/2012 at 02:43

Dear All,

1. Is it required to consider three different KSM batches material for three API-process validation batches or

2. Only one KSM batch material is quite enough to execute three process validation batches.

if so, is it mentioned in any regulatory guidelines to support option 1 or 2

Thank you,

Answers to this contribution:

• RE: KSM usage in process validation from Nick (4/20/2012 07:15)
• RE: KSM usage in process validation from vasks (4/18/2012 04:53)
  • RE: RE: KSM usage in process validation from Bruno (5/10/2012 06:42)

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