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* 1. Does your company employ the <24hr rule to decide whether the Process Hold needs validating or not (as is considered part of ongoing processing)?

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* 2. Does your company perform PPQ taking into account maximum hold times for intermediate holds and/or process step holds?

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* 3. Does your company see the need for a technical document to provide guidance on what/how to validate for Process Hold Times, or are the Regulatory texts sufficient?

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