FDA Issues Final Guidance on API Good Manufacturing Practices Guidelines

The FDA released final guidance on its Q7 guidelines on good manufacturing practices for APIs, using a question and answer format to clarify the document developed through the International Conference on Harmonization.

The agency said it “generally” expects annual product quality reviews but time frames can be adjusted to more or less than 12 months, with proper justification.

Quality reviews should be undertaken even if no manufacturing took place in the review period and should include stability, complaints, returns and recalls, as well as trend analysis, the agency said.