The U.S. Food and Drug Administration (FDA) inspected manufacturing facilities, Changzhou Jintan Qianyao Pharmaceutical Raw Materials, from February 13-17, 2017. As a result of significant deviations from current good manufacturing practice (CGMP), the FDA placed the firm on Import Alert 66-40 on May 4, 2017. Subsequent to this Import Alert, a Warning Letter was issued on May 11, 2017. This Blog addresses the primary citations of this Warning Letter. To visit the complete Warning Letter, please go to:
- Failure to implement a system for managing quality encompassing the organizational structure, procedures, processes and resources, as well as activities to ensure confidence that the API will meet its intended specifications for quality and purity. Failure to define and document all quality-related activities.
- Failure to have adequate written procedures for the receipt, identification, quarantine, storage, sampling, testing, handling, and approval or rejection of raw materials.
- Failure to have laboratory control records that include complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards.
- Failure to prepare adequate batch production records and record the activities at the time they are performed.
API CGMP Guidance
FDA considers the expectations outlined in ICH Q7 in determining whether API are manufactured in conformance with CGMP. See FDA’s guidance document, Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, for guidance regarding CGMP for the manufacture of API, at:
One of the most interesting aspects of this Warning Letter was the speed in which the FDA audited, provided an Import Alert and issued a Warning Letter. All of this occurred within a time frame of only three months – perhaps a record for the FDA. Ironically, product had been historically shipped to the United States as an API prior to this audit. Perhaps this is what gave the FDA additional incentive – especially in light of the Citations.
Please also visit my list of upcoming seminars and webinars on my Blog site at:
Please note that the upcoming seminars in Copenhagen (June 29/30) and Boston (July 17/18) discuss this subject matter in greater detail over a two day period.