PDA Process Hold Times
*
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)?
(Required.)
Yes
No
*
2.
Does your company perform PPQ taking into account maximum hold times for intermediate holds and/or process step holds?
(Required.)
Yes
No
*
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?
(Required.)
