GMP Compliance Adviser Update No. 2/2018
With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:
|6.F||Operational Qualification (OQ)|
|6.G||Performance Qualification (PQ)|
|E.12||Draft Version ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management|
Chapter 6 Qualification
6.F Operational Qualification (OQ)
During Operational Qualification (OQ) the functionality of the installed equipment is tested and documented for the entire range of intended operation. The scope of testing during the individual qualification steps is determined based on the risk analysis. Deviations which occur may lead to interruption of the qualification activities. They must be corrected and documented.
The successful execution of IQ and OQ is a prerequisite for achieving the qualified status of the equipment. Depending on the equipment, performing the qualification may also include a PQ; in this case the qualified status is obtained after conclusion of the PQ.
The implementation of an OQ is presented for a fluid bed dryer as an example. (Thomas Peither, Ulrike Reuter, Rainer Röcker)
6.G Performance Qualification (PQ)
During a Performance Qualification (PQ) the interactions between individual components in a production line or plant are tested. The performance tests conducted in consideration of the range limits after conclusion of OQ serve to establish that the interaction of the entire unit functions properly. Documentation of a Performance Qualification is performed, as for other qualification stages, using a PQ plan, PQ test protocols and a PQ report. The execution of the PQ can occur as part of a Process Validation.
The implementation of a PQ is presented for a filling line as an example. (Thomas Peither, Ulrike Reuter, Rainer Röcker)
Chapter E ICH Guidelines
E.12 ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Step 2
Three years after the publication of a concept paper Q12 “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management”, the ICH published the Step 2 draft document including an Annex with illustrative examples in December 2017.
The intention behind ICH Q12 is to provide guidance on a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more predictable and efficient manner across the lifecycle of a product. The guidance addresses the commercial phase and should be seen as the logical continuation of the ICH Q8 – Q11 Guidelines. The 31-page draft is planned to being finalised in the second quarter of 2018.