FDA 483 Trending Topics & Solutions Recap

The FDA 483 Trending Topics & Solutions Recap was written by Sumita Som about the Joint Networking Event: ASQ, PDA and SoCalBio for ASQ’s Food, Drug and Cosmetic division, who helped sponsor the event.

See the presentations:

• Marlene Garcia Swider, Presentation on 483 Trending Topics
• Barbara Unger, Remediation of “Data Integrity” and “Documentation” Form-483 Observations
• Susan Bain, Visual Inspection Execution & Documentation of Defects and Container/Closure Integrity
• Michael Hamrell, Moderator

This was my first time attending the ASQ -FDC -PDA -SoCalBio joint networking event on 6 October 2016 in beautiful Irvine, California.  The event was introduced by Ruchika Raval (PDA), Brian Underhill (SoCalBio) and event moderator Michael Hamrell. This was followed by the speakers and panel members: Marlene Garcia Swider, Barbara Uger, and Susan Bain, sparked the discussion on the warning letters and their trends.

The technical Sessions on FDA 483 Trending Topics by Marlene brought to light “Why are data integrity documentation, visual inspection and package integrity important?” … of the various quality issues that surface during inspection leading to 483s. Marlene focused on the fact that not just Data integrity, but timeliness is of paramount importance. Also, everyone involved in the process of producing a drug and packaging it, are responsible for package integrity. The reasons for the issuance of 483s, were the details in the SOPs on how the inspections needed to be performed. The commonly found reasons for the 483s were categorized in the areas of Biologics, Medical Devices and Drugs.

According to Barbara, lack of data integrity is not a single disease! In the sense that these problems do not exist in isolation, we need to have a holistic approach to include GLP and GDP systems for a successful remediation. While Susan shared some concerns on Visual inspections and documentation of defects pertaining to poorly done Corrective and preventive actions. The importance of human visual inspection is still used as a reference standard for visual inspection than machine. This is  due to the incredible capability of human eye in being able to respond to newer defects was emphasized. Takeaways from some surveys and studies were also very informative.

Round Table discussions with the panel gave an interesting insight to understand the 483 warning letters from a regulator’s perspective. This pertains to reading them carefully, where mostly these violations  range from practices like shared passwords, poor computer validations, lack of documented evidence and basically, missing fundamentals! Root causes are usually deficiencies in tools and lack of training people. Overall it was a good learning session where regulatory concerns could be understood at a deeper level and solutions gathered in a holistic manner towards making a more robust industry discipline.

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