Lot Release of Vaccines by NRAs/NCLs
Lot release of vaccines by, as a minimum, review of a summary protocol and access to a laboratory are two of the essential functions of a national regulatory authority for assuring the quality of vaccines used in the immunization programme as defined by WHO. Lot release is the process of evaluating each individual lot of a licensed product before giving approval for its release onto the market. This process is carried out for vaccines and other biologicals in most countries. General practices of release involves the review of manufacturer's production data and quality control test results (product summary protocol) by the national regulatory authorities (NRA) and national control laboratory (NCL)s. This may or may not be supplemented by laboratory testing by the national control laboratory, or by an agency or contracted laboratory performing tests for the NRA.
WHO member states have requested revised guidelines for lot relese of vaccines by NRAs. WHO has therefore initiated a process to develop state of the art guidance for lot release of vaccines. Challenges to the present lot release system included the increased number of vaccines now licensed and in use, the increasing complexity of new vaccines requiring more sophisticated tests, and the increasing globalization of the industry. These factors create an increasing burden for NRAs and for the industry, particularly for developing countries with limited regulatory experience and resources and often unable to cope with traditional vaccines let alone new biotechnology products. Indeed, it is relevant to ask why have independent lot release by NRAs? Is it still relevant in the 21st Century? Is it effective? What are its disadvtanges and can it be done better?
Guidelines for independent lot release of vaccines by regulatory authorities, TRS (in press), (ECBS 2010)