USP <1115>—Bioburden Control of Nonsterile Drug Substances and Products
The control of microorganisms when manufacturing products that are nonsterile is an ongoing challenge. Since the products are intended to be “nonsterile,” there is an inherent acceptance that organisms may be present in the product; however, there are also strict guidelines that require the product to be safe for the intended users. It is the responsibility of the manufacturer to ensure that the product is free of objectionable organisms.
There hasn’t been much industry guidance for manufacturers of non-sterile products. Many manufacturers have used aseptic processing guidelines as a starting point for the production of non-sterile products. In most cases, the strict guidelines for sterile products are not needed for products which have far less risk, like non-sterile products. The USP has recently released a draft of a proposed chapter that gives some insight into the microbial control of non-sterile products during the manufacturing process: USP <1115> Bioburden Control of Nonsterile Drug Substances and Products.
The guidance chapter suggests using a risk based approach to identify the microbial control risks during the development and manufacturing of non-sterile products. Specifically, the chapter covers a wide range of important information that should be reviewed when performing a risk assessment including U.S. regulatory guidance outlined in the Food and Drug Administration’s Good Manufacturing Practices, considerations during development and manufacturing, microbial control, assessments of environments, and overall quality management.