The FDA Draft Guidance on Insanitary Conditions in Compounding Pharmacies is a concise summary of top issues uncovered during the agency’s compounding pharmacy audits conducted in the wake of the 2012 meningitis contamination. The draft guidance is quick to point out the list is not exhaustive and does not include all conceivable insanitary conditions.
However, what the list also lacks in my read is an emphasis on the proper place of testing to confirm whether sanitary conditions exist, regardless of visible facility condition, compounding processes and technician practices. Below is a list of tests which are necessary to confirm adequate remediation of those insanitary conditions listed in the draft guidance:
I would add to this list disinfectant efficacy studies, cleaning validations, and of course validated finished product sterility and endotoxin testing.
Not every compounding pharmacy will have a trained microbiologist on staff. The tests listed above require significant training, qualification and experience to perform. As the draft guidance states in Lines 307-309, compounding facilities should “consider consulting a third party with relevant drug production experience to conduct this comprehensive evaluation and to assist in implementing appropriate corrective actions”.
Atlas offers a complete compounding pharmacy solution. We perform gap assessment, provide corrective actions, and support with qualified expert testing. Our laboratory is cGMP compliant, FDA registered, and customer focused.