Quality assurance and quality control

In recent years, quality assurance (QA) and good manufacturing practice (GMP) have become increasingly important in the pharmaceutical industry. They are of particular importance in the manufacture of veterinary vaccines since such products have the following specific characteristics: The active ingredients are almost always produced by the manufacturer (and not as is generally the case by another industry, as for example with chemicals). Vaccine production usually requires cultivation steps, including growth of the appropriate organism and the use of substances of animal origin, which makes it easy to introduce a contaminant and to amplify low levels of contamination. As the end product is not usually subjected to a final sterilization step, prior to final formulation its constituents should be particularly well protected against contamination and cross-contamination. Manufacture requires the handling of live organisms which are sometimes pathogenic for hurnans and / or animals. The release of these agents, with the possibility of contamination/ cross-contamination , has to be regarded as a serious danger and, depending on the organism involved, the workers and the environment , together with all the materials, should be well protected. Moreover, the level of risk is further exacerbated by the large number of animal species and potential pathogenic agents. The variety d manu during of products manufactured is very great but the volume of manufacture is sometimes quite low, so manufacturing operations based on the sharing of equipment and facilities is common. In addition, other activities such as diagnosis and research are frequently linked to manufacture and this may result in opportunities for cross-contamination. Vaccine manufacture is a complex activity, with risks, which is carried out in a complicated environment. Particular aspects of the work are important in relation to potential problems of contamination , for example contamination of the product, cross-contamination, possible amplification of contamination organisms and contamination of workers and the environment. These factors, together with the inherent variability of biological agents and materials and the relative inefficiency of quality control tests in providing adequate reassurance for final products, means that the roles of the QA system and GMP are of the utmost importance. Not only should the requirements of general current GMP for medicinal products be applied, but also the specific requirements of particular products. The need to maintain control over all aspects of GMP cannot be overemphasized. In this chapter an overview of QA and GMP, with special attention to some of …