Avoiding Non-Compliance in Packaging Areas

Recommendation

27-29 February 2024

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Management, Supply and Quality Assurance of Clinical Trials

During an inspection of a manufacturer of solid oral dosage forms the FDA observed incidences of water leakage from the ceiling of the encapsulation room: Capsules were exposed to leaks during multiple batch encapsulation operations.

In addition, there were instances of water leaks in the packaging area. Some occurred during filling tablets into open containers. Some of these leaks occurred above the packaging lines. According to the FDA this may pose a risk to the quality of finished drug products, in particular the moisture sensitive drugs. According to the FDA the executive management of the company failed to fully recognize the risks from these leaks.

The FDA therefore requires:

• A retrospective review of drugs that may have been negatively impacted, including both chemical (e.g., dissolution, degradants) and microbiological attributes. The review should include factors such as elevated moisture levels due to leaks,
• Assessment of all records that would yield such information, including records on maintenance, deviations, and facility repairs,
• Testing of retain samples of moisture sensitive drugs manufactured during periods that leakage occurred.

In addition, the FDA commented in the Warning Letter that the manufacturer lacked data showing that the process was in "state of control" before batch release.

On the FDA website you can find the complete Warning Letter to Aurolife Pharma.