[Stability Testing related News – vol.10]

◆ Revision of the EU GMP Annex 15 for Qualification and Validation (11-Feb-14 ECA)

The European Commission has published the draft of the Annex 15.

The revision is very extensive. Influences of the ICH Guidelines Q8, 9, 10 (and 11) are clearly visible – even in the glossary. The subject Design Space (ICH Q8) is now also covered in the area Process Validation. Many risk considerations (ICH Q9) are now mandatory. The life cycle approach and process knowledge (ICH Q10) are now included as well. Deviation management gained in significance. Third party services are now authorized explicitly if the supplier has been qualified correspondingly. This is a positive adaptation to reality. The mention of preliminary approvals – e.g. in the case of deviations – is good for a next (validation / qualification) stage, if there is a documented assessment showing that there is no significant impact on the next stage. Unfortunately a clear differentiation between qualification (based on equipment and facilities) and validation (related to processes) is missing. This is a shortcoming that unfortunately exists in many European regulations.

The draft comment period is relatively short and ends (unfortunately) already end of May 2014.

◆ Draft guidance of Analytical Procedures and Methods Validation for Drugs and Biologics (19-Feb-14 FDA)

US FDA publishes a draft guidance of analytical procedures and method validation for drugs and biologic from view point of life cycle and revalidation.

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM386366.pdf

◆ System Suitability for USP Methods (12-Mar-14 ECA)

An interesting article from the USP experts group has been published in the Pharmacopoeial Forum 39(5). It deals with small molecules and describes the requirements regarding system suitability tests (SST) for chromatographic procedures submitted in new or revised monographs.
System suitability tests are performed each time a chromatographic method is used. They thus belong to the scientific working practices in the laboratory beside analytical instruments qualification, and methods validation.

You can find all information on the USP website of the Pharmacopeial Forums (PF).

◆ Qualification and the new Annex 15 Draft ( 02-Apr-14 ECA)

The comment period for the new Annex 15 draft “Qualification and Validation” started at the beginning of February. Still, the coming into force of the new version is planned for October 2014. Yet, as the comment period should have already begun from December 2013 on, the coming into force could also be postponed.

The consequent use of the risk management approach and lifecycle observation for validation and qualification is a central and essential issue of the new document. Qualification should now start with the creation of the user requirements URS; The Design Qualification (DQ) as verification will thus become the second step within qualification. Until now, DQ had always been described as the first step.

The reference for the first time of FAT and SAT (Factory and Site Acceptance Test) is something new whereas retrospective qualification has been completely removed. The FAT is even compulsory for more complex equipment  i.e. for their qualification.

An own new chapter entitled “Validation of utilities” is now dedicated to the qualification of media. Seasonal variations should also be considered – where applicable – in the context of qualification. For risk assessment, a difference is made between systems with direct (HVAC) and indirect (i.e. heat exchangers) contact with the product.

Also the chapter on re-qualification has now become a separate chapter and has thus become an explicit requirement. Up to now, re-qualification had only been indirectly required via re-validation. As qualification is regarded as part of validation, the requirement on regular re-validation has been transferred to re-qualification.