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.

It clarified that the quality unit is not expected to perform sampling, but it is responsible for reviewing and approving sampling plans and procedures — and sampling should be performed and documented by adequately trained personnel.

The person in the quality unit responsible for final decision-making — such as batch release decisions — should not be responsible for production activities, to prevent conflicts of interest and biased quality-related decisions in the company’s organizational structure.

In addition, the agency clarified that while the quality unit is responsible for API releases, including oversight of testing and results, Q7 does not specifically state who should perform the testing, as the term “quality control” in the guidance’s glossary refers to quality control activities, not organizational structure.

The quality unit is responsible for instituting a system to release or reject raw materials, intermediates, labeling and packaging materials and cannot transfer its responsibility. However, it may allow other departments to release or reject raw materials and intermediates — except for intermediates used outside the manufacturer’s control — as long as oversight and overall responsibility of the system stay with the quality unit.