Hi All,
I’m looking for some feedback on what people consider industry standard approach for validation of replicated manufacturing lines (i.e. additional line qualification).
Summary of an approach I’ve encountered:
IQ: IQ is universally executed for all equipment on a replicated line.
OQ: OQ is generally not repeated if there are no changes to the process, environment, etc.
PQ: PQ generally repeated in full, or a reduced testing PQ based on historical confidence.
My queries are; Is this approach similar to what others have encountered? What statistical techniques are people seeing employed for PQ of an additional line? And what guidance have people seen published on this topic, regulatory or otherwise?
I’ve posted before on this subject and got some good feedback. I’m reaching out again to see if there are any differing approaches being utilised.
Note IQ / OQ / PQ definition as follows:
"IQ – Evaluation of processing and test equipment is required to ensure that the equipment and its software have been manufactured/installed to the manufacturer’s specifications and are capable for the intended operation.
OQ – provides a high degree of assurance that the process, when run at predetermined limits, is capable of producing product that meets all specifications.
PQ – demonstrates that the process, when run under normal operating conditions is capable of consistently producing product that meets predetermined specifications.
Regards,
Paddy.