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GMP News

When "Undetermined" is not an Answer: What two FDA Warning Letters Show about Root Cause Analysis and CAPA

Two recent FDA Warning Letters highlight a recurring weakness in pharmaceutical quality systems: treating an investigation as complete before the organisation knows what really happened, assessed the full product risk, and implemented actions capable of preventing recurrence.

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Regulators Approve Post-Approval Change Protocol for Endotoxin Testing: From LAL to Recombinant Methods

Following a coordinated review by six international regulatory authorities (EMA, FDA, Australia’s TGA, Health Canada, Japan’s PMDA and Swissmedic), the approval of a Post-Approval Change Management Protocol has been announced. The protocol supports a manufacturer’s transition from the traditional horseshoe crab-derived LAL test to a recombinant alternative for several biological products.

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FDA Warning Letter: Aseptic Processes strongly Criticised

The FDA has identified serious weaknesses in Eugia Pharma Specialities’ manufacture of sterile injectable drugs. Inadequate RABS barriers, frequent manual interventions, poor cleanroom practices and incomplete media fills raise concerns about the robustness of the company’s sterility assurance strategy. Similar findings at multiple sites are also placing the company’s global GMP oversight under scrutiny.

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