Quality assurance vaccines

Burman, Mary C., M.N., Joint Vaccine Acquisition Program, Project Management Office Regulatory Affairs, Quality Assurance, June 27, 2001. 

Create a supply list (see Table 24.6) for the entire jurisdiction. Maintain centralized inventory of items that are difficult to obtain. Identify appropriate storage facilities. Ensure that personnel and protocols are in place for quality assurance monitoring and maintaining appropriate storage temperatures checking lot numbers and expiration dates. Develop guidelines for vaccine/prophylactic medication distribution... 

Dellepiane N, Griffiths E, Milstien JB. New challenges in assuring vaccine quality. Bull World Health Organ 2000 78(2) 155-62. 

WHO therefore undertook a project with the above-mentioned United Nations partners, which was supported in principle by the World Bank. The project focused on the prequalification of products and manufacturers of HIV/AIDS-related products, and the drafting of a model quality assurance system (hereafter referred to as the Model). This Model is intended to assist organizations purchasing pharmaceutical products, vaccines, or other health sector goods or which are otherwise involved in the prequalification, purchasing, storage and distribution of such products, hereafter referred to as procurement agencies, to procure safe, effective pharmaceuticals of suitable quality. 

Dr S. Lambert, Quality Assurance and Safety Biologicals, Department of Immunization, Vaccines and Biologicals, WHO, Geneva, Switzerland... 

The quality control of vaccines is intended to provide assurances of both the effieacy and the safety of every batch of every product. It is executed in three ways ... 

Robertson, J. and Griffiths, E. 2001. Assuring the quality, safety and efficacy of DNA vaccines. Molecular Biotechnology 17(2), 143-149. 

Many antigens currently marketed would be inherently toxic except for the fact they have been stringently detoxified. Some of the most successful and durable vaccines today include toxoided forms of tetanus, pertussis, and diphtheria toxins. During the manufacturing process, these toxoids undergo significant chemical modifications, and their toxic properties are effectively eliminated. The safety is assured with every batch release and defined within safety charac-terization/quality control tests, which are not discussed in this chapter. 

Use in the production of vaccines As assay organisms to determine antibiotic, vitamin and amino acid concentrations Quality control of immunological products Assay methods Sterilization methods Sterilization monitoring and validation procedures Sterility testing Assessment and calculation of sterility assurance Aseptic manufacture... 

WHO Guidelines for assuring the quality of DNA vaccines. Annex 3 in WHO Technical Report Series, No. 876, 1998. 

---