ABSTRACT
The importance of controlling microbiological contamination in pharmaceuticals, cosmetics and toiletries has been recognized for many years, the acceptance and implementation of microbiological standards for such products have, by comparison, developed more slowly. This chapter describes the way in which both official and unofficial microbiological standards have developed over the years, the detailed content of those standards, and how they have been implemented in practice. The first microbiological standards were based upon the criterion of sterility and initially applied only to that most critical group of pharmaceutical products, the injectable preparations. Many manufacturers of both pharmaceutical preparations and cosmetic and toiletry products have over the years developed their own in-house microbiological guidelines and limits. In comparing the development of both official standards and in-house guidelines in recent years, it is apparent that the widespread acceptance of such guidelines by industry and hospitals has to some extent influenced their subsequent inclusion in official standards.
