Validation of production processes for vaccines for WHO prequalification - compliance expectations
A revised procedure for WHO prequalification of vaccines was endorsed by the WHO's Expert Committee on Biological Standardization (ECBS) in October 2010. Vaccines are currently prequalified as per this revised procedure.
Manufacturers have requested guidance from WHO on systems and means to validate their production processes and analytical methods. The exercise of validation ensures that product is consistently produced to the specified standards for prequalification purposes. The validation and its scope is usually detailed in a master validation plan of the manufacturer.
To assist manufacturers to implement appropriate validation procedure, this document on “Validation of Production Processes for Vaccines for WHO prequalification - Compliance Expectations” has been developed. This document has already undergone a few rounds of consultations with GMP experts, vaccine manufacturers, National Regulatory Authorities and WHO staff.
The document is now posted for wider consultation and comments. It should be seen as a guidance to manufacturers of prequalified vaccines, and as a complement to the Procedure for assessing the acceptability, in principle, of vaccines for purchase by United Nations agencies. WHO/BS/10.2155. It provides the basis for the minimum scope for validation of production processes. It is a guidance limited to vaccines and it is recognized that it is not an all-inclusive document. As such, manufacturers should apply a flexible approach where new or certain approaches are not described in this document. It is also advised that this guidance should be interpreted on a case-by-case basis.
The WHO Prequalification Secretariat requests comments, observations and / or recommendations to this draft addressed to email@example.com and firstname.lastname@example.org by 20 September 2013.