FDA Warning Letter for inadequate Batch Record Review
The U.S. Food and Drug Administration (FDA) recently posted a Warning Letter for a Chinese API manufacturer criticising the quality unit for not exercising its responsibility adequately.
For example, batch production records
- "contained blank or partially completed manufacturing data"
- "lacked dates and signatures for verification"
- "contained sticky notes from the quality assurance department directing operators to enter manufacturing data"
- were not approved by the quality unit
Also other documents like, for example, cleaning records and equipment use logs were found "without dates and signatures for verification, or with pages or spaces intentionally left blank for documentation at a later time".
As a conclusion, FDA stated that these "significant inspection findings indicate that your quality unit is not fully exercising its authority and/or responsibilities". And FDA placed the company on Import Alert.
Source: FDA Warning Letter to Qinhuangdao Zizhu Pharmaceutical.
Related GMP News
10.02.2025Is "right-sizing" GMP and Compliance (Lean GMP) possible?
10.02.2025Update of Training Material for ICH Q8, Q9 and Q10
05.02.2025European Shortages Monitoring Platform (ESMP) goes live
05.02.2025The ICH Q9 Briefing Package - a Forgotten Document?
23.01.2025FDA proposes Standardized Testing for Asbestos in Talc-Containing Cosmetic Products
16.01.20252nd Version of the Union list of Critical Medicines published