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 release of vaccine by NRAs. WHO has therefore initiated a process to develop state of the art guidance for lot release of vaccines. Challenges to the present system of lot release 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 disadvantages and can it be done better?
To review the current situations in performing lot release of vaccines, tackle the challenges and meet the need of its member states, meetings and consultations are to be organized by WHO with broad participation of NRAs, NCLs, vaccine industries, academy and professional organizations. The meeting reports provide a detailed picture of current thinking by leading NRAs/NCLs and will lead to the development of new WHO guidelines on lot release.
Based on the outcome of the first two meetings, there is general agreement from both regulators and industry that lot release for vaccines is desirable to provide additional assurance of safety and quality to both manufacturers and the public to provide confidence in immunization. However, the process has to be reliable and should not disrupt vaccine supply. The process of developing new WHO guidelines will also identify improvements in the present system.