Wednesday, September 11, 2019

Warning Letter of the Week: pre-approved batch records

A missive from the Center for Drug Evaluation and Research to the President of Enprani Co., Ltd. in Seoul, South Korea (emphasis mine) 
2. Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)). 
During the inspection, our investigator observed that your quality unit (QU) lacks adequate oversight for the manufacture of your OTC [redacted] drug products. For example:
  • Your QU failed to review entire batch records, including raw data and calculations for accuracy, before making appropriate release determination.
  • Your batch records were pre-printed as “approved” indicating the assay results were in specification, even before these values are recorded.
  • Label review and line clearance were not performed and documented in batch production and control records.
Pre-printing approvals - how come I never thought of that? 


  1. The reason for actions lie this was given by QA expert and musician Cyndi Lauper - money changes everything.

    1. I think "Money's not the most important thing - it's the only thing" might be more relevant.


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