Immunization standards

Deviation handling and quality risk management

A revised procedure for WHO prequalification of vaccines was endorsed by WHO's Expert Committee on Biological Standarization (ECBS) in October 2010. Vaccines are currently prequalified as per this revised procedure.

During normal life cycle of vaccine manufacturing, many expected and unexpected deviations may happen or be observed. These deviations may be planned and sometimes unplanned. These deviations are not according to approved SOPs and systems. Although manufacturers do their best to avoid these deviations they are naturally unavoidable. These deviations may have minor to major impace on the quality of the product and may pose a quality risk of varied nature. Thus it is important to have a uniform and systematic approach to deviation handling and assessing risk to the quality of the product. Manufacturers have requested guidance from WHO on deviation handling and its impage on quality risk management.

To assist manufacturers to implement appropriate harmonized procedures this document on "Deviation handling and quality risk assessment" has been developed. This document has already undergone several rounds of invited 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 guidance on approaches to handling planned or unplanned deviations and assessing and managing quality risks. It is a guidance limited to vaccines and it is recognized that is is not an all-inclusive document. As such, manufacturers shoul 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 you to send comments, observations and/or recommendations to this draft addressed to and by 1 November 2013.