Warning Letter for inadequate Batch Record Design and Review

Recommendation

13/14 December 2023
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

The U.S. Food and Drug Administration (FDA) recently posted a Warning Letter sent to a US pharmaceutical company criticising their incomplete batch production and control records.

For example, batch production records were missing critical production information on the coating and blending process.

FDA now expects the company to provide "appropriately detailed master batch records that capture all significant manufacturing steps" for each of the company's drug products. Furthermore, a remediation plan is expected to assure "ongoing management oversight throughout the manufacturing lifecycle of all drug products". FDA also thought that the quality unit's oversight of the company's drug manufacturing operations was inadequate: "Your firm lacked adequate written procedures for many QU (i.e., quality assurance) functions, for example, review and approval of executed batch records, batch release, investigation of out-of-specification (OOS) results, cleaning, equipment qualification, stability testing, gowning, and sample control."

You will find the details in the FDA Warning Letter to Health Pharma USA.