Following these five rules will ensure that OOE investigations are conducted in a scientific and meaningful manner, with each instance providing a genuine opportunity for improvement.
On-site cGMP audits are an important part of creating and maintaining a compliant, reliable, and secure supply chain that safely provides high-quality clinical and commercial drug products when and where needed. An important auditing decision is whether to use an individual or pooled audit.
FDA inspectors continue to observe CGMP violations involving data integrity during CGMP inspections of laboratory operations. At least 20 percent of all warning letters issued by the CDER Office of Manufacturing Quality in 2017 included explicit observations by inspectors of blatant data integrity violations in laboratory operations. While there has been an increase in warning letters issued to firms in China and India for flagrant data integrity violations, firms in the United States, Europe, and Japan have also been cited with similar violations.
This two-part article will address how sponsors can effectively ensure confidence in data integrity at their contract development and manufacturing organizations (CDMOs) and have confidence in the information upon which they base lot release decisions.
Success in developing a drug product, medical device, or drug substance requires navigating the tradeoffs and decisions of today’s complex global regulatory realm. Some of the most common questions about compliance concern dealing with the FDA 483 list of inspection observations, warning letters, and consent decrees following FDA regulatory action.