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Guidance on Good Manufacturing Practice for APIs finalized by FDA

The FDA has finalized the guidance on Good Manufacturing Practice (GMP) for active pharmaceutical ingredients (APIs) which is based on the International Conference on Harmonization (ICH Q7) guidelines. The revised guideline is based on question and answer format so that responses can be provided to requests for clarification of uncertainties due to interpretation of certain sections in the ICH guidance.

The guidance provides GMP for the manufacture of APIs under an appropriate system for managing quality and to help companies ensure that APIs meet the quality and purity characteristics.

According to the guidance annual product reviews is generally expected by FDA however time frames can be adjusted to more or less than 12 months depending upon product campaign duration. In the guidance FDA makes it clear that irrespective of whether the manufacturing took place or not during the review period, the product quality reviews should still be carried on and should include complaints, returns, recalls and stability, as well as trend analysis. In 2017, The European Medicines Agency and FDA both agreed to carry out GMP inspections of pharmaceutical manufacturing sites conducted in their respective territories on both sides of the Atlantic.