ABSTRACT
This chapter will discuss the microbiological analysis of nonsterile pharmaceutical products with emphasis in the microbiological test requirements and test methods. When a nonsterile pharmaceutical product is manufactured, quality control evaluation includes the microbiological testing of raw materials, excipients, active ingredients, bulk, and finished products. However, because of their nature, nonsterile samples contain high numbers of microbes andobjectionablemicroorganisms thatmight represent a serious health threat to consumers. High number of microorganisms can also change the chemical composition of a given pharmaceutical formulation by spoilage, affecting the stability and integrity of the product and package. Furthermore, since these products are not sterile, a microbial bioburden is allowed based upon the product specifications. This means that although there are microorganisms present in the sample, their quantity and types will determine the safety of that particular pharmaceutical product and efficacy of the manufacturing process. Therefore the microbiological testing of nonsterile pharmaceuticals is defined as microbial limits [1]. How and when to define those limits is based upon:
Chemical composition of product Production process
MD: JIMENEZ, JOB: 03330,
Route of application Intended use of product Delivery system of product
Nonsterile pharmaceuticals are manufactured under aseptic conditions, but the processes used during production are not monitored on a regular basis. Furthermore, the criteria for manufacturing nonsterile pharmaceuticals are completely different when compared to sterile products. To date, there are no regulatory or compendial guidelines. However, according to the code of federal regulations (CFR) part 211.113, companies must have appropriate written procedures, designed to prevent the presence of objectionable organisms from drug products not required to be sterile [2]. This includes standard operating procedures (SOPs) for manufacturing and quality control analysis of each nonsterile product. Written procedures for manufacturing, packaging, and quality control analysis allow reproducibility, continuity, accuracy, and process control.
