ABSTRACT
This chapter presents the principal microbiological considerations for manufacturers of non-sterile pharmaceuticals, with strategic information for non-sterile manufacturers to achieve contamination control programs that are risk-based, scientifically sound, and suitable for their specific products and processes. Virtually all pharmaceutical manufacturing is performed under non-sterile conditions. Pharmaceutical products, whether labeled as sterile or non-sterile, are always required to be safe for their intended purposes. The actual and potential microbial content are major factors in performing a product safety assessment. The paradigm that Grade A/ISO 5 clean rooms are “sterile” contributes to the assumption that some significant error had to occur to result in a contaminated product. The key issue concerning microbial contaminants in non-sterile products is the potential for those organisms to harm the user. An organism capable of causing a disease is referred to as a pathogen. An organism that will cause a disease or set up an infection under certain circumstances is called an opportunistic pathogen.
