Manufacturing of drug products intended to be sterile presents a difficult challenge, especially when those products are produced using aseptic processing techniques. FDA has enacted several regulations and published guidance documents to assist industry and FDA investigators in evaluating manufacturing controls for drug products intended to be sterile. However, FDA inspections often find objectional conditions where firms producing products intended to be sterile are not in compliance with the regulations. Non-compliance with the GMP regulations is a concern for the industry. It also calls into question the quality and safety of drug products intended to be sterile and poses a risk to the patients who take those products. FDA inspections revealing non-compliance with the regulations are often just the first step in an increasing regulatory continuum which can lead to warning letters, consent decrees and other regulatory sanctions if the non-compliant conditions are not quickly and effectively resolved.
This training course will provide an in-depth overview of FDA regulations and guidance pertaining to the manufacture of drug products intended to be sterile. It will also provide specific examples of cases where poor practices have resulted in adverse regulatory findings and discuss how these practices could have been avoided.