The UK's Medicines and Healthcare Products Agency has ordered India's Akums Drugs and Pharmaceuticals to recall four batches of progesterone produced at its Hardiwar facility due to critical deficiencies uncovered during an April 2016 inspection. The Statement of Non-Compliance with GMP published on the EudraGMP website noted that one critical and three major deficiencies were uncovered during the inspection. The critical deficiency was for lack of sterility assurance, and the major deficiencies were for inadequate control and validation of sterilization, deficiencies across all aspects of the quality management system, and lack of a robust environmental monitoring program. Thirteen other deficiencies covering all aspects of GMP were recorded but not formally reported so as not to distract from the critical and major deficiencies.
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