Probably one of the most significant developments in sterilization and aseptic practices in pharma is that of vaporized hydrogen peroxide (VHP) as a contact or “cold” sterilizing agent. The use of VHP in contained environments has allowed us to decontaminate working spaces, equipment, and materials and has led to the development of the reliable isolator.
According to section 503B of the Food Drug and Cosmetic Act, outsourcing facilities are required to comply with all current good manufacturing practices (cGMPs) and regulations regarding insanitary conditions. Many regulatory observations are written for the failure to follow cGMPs and insanitary conditions. This article highlights some of the microbial expectations for 503B compounding pharmacies.
Microbial control for non-sterile manufacturing helps to ensure the safety and efficacy of pharmaceuticals. Products that are compromised with excessive amounts of microorganisms, specified microorganisms, or objectionable microorganisms may not be effective or could be dangerous to consumers. Unfortunately, the regulations governing non-sterile manufacturing are not as clear or as abundant as those for sterile manufacturing. This leads many manufacturers to utilize risk assessment analysis tools to adapt portions of sterile manufacturing guidelines when developing environmental monitoring programs for non-sterile environments.
Manufacturers of sterile products must engage in critical thinking, asking “Why?” and “Why not?” questions, challenging and pushing the industry towards more effective means of quality and process control. In this way, we can ensure that we are prepared to meet the challenges of providing sterile pharmaceutical products that are not only safe and effective, but also are available and affordable for the patients who depend on them.