The latest version of Annex 15, Qualification and Validation Guide to Good Manufacturing of medicines for human and veterinary use, comes into force on October 1st 2015. The update takes into account technological and regulatory changes introduced in other sections of Part I and Part II of the GMP and ICH guidelines Q8, Q9, Q10 and Q11 and QWP on process validation.
 
The following summarizes the major changes in the document, which generally focus on the life cycle of facilities, equipment, services, processes and product from initial development to its retirement, and in the use of documented risk management systems for quality as a basis for defining the scope and scale of the tasks of the validation or qualification of the above items.
 
The changes highlight the requirement that the staff responsible for validation tasks are properly trained or qualified, and there be  supervision by quality unit throughout the validation lifecycle .
 
As for the validation dossier, the Validation Master Plan should contain more information, and the qualification phases for equipment, facilities, services and systems include in this new version the User Requirements, and the execution of factory acceptance tests and plant acceptance tests. The possibility of combination of qualification or validation protocols is highlighted.
 
Regarding the validation process, three types of approaches are recognized: traditional, continuous and hybrid verification, and requires the verification of the process throughout the product life-cycle. Another major change is the exclusion of retrospective validation as acceptable approach in process validations.
 
Indications on cleaning validation have remained in this last version, and those related to transport verification, validation conditioning, service qualification and validation of analytical methods have been added.

Asfalia presents today its new website, which has been completely redesigned to improve its navigability and include new contents.  We pretend to provide up-to-date useful information on the Computer Validation field, in a more modern, dynamic and accessible way. We thank our clients and visitors any input on any of its aspects, both in terms of design and content.