Wednesday, February 20, 2019

Warning Letter of the Week: wood burner edition

Via a friendly note from the Center for Drug Evaluation and Research to the Chairman and Managing Director of Vipor Chemicals Private Ltd. (Gujarat, India):
2.      Failure to have the procedures and processes necessary to ensure the API manufactured at your facility meet established specifications for quality and purity.
Batch Control
You do not have a procedure to control the issuance, usage, and reconciliation of batch manufacturing records (BMRs). Your production personnel record manufacturing activities in personal notebooks or on draft BMRs. Production managers then transcribe the data onto another BMR, which is then circulated to the production operators and supervisors for their signatures. Production management stated that drafts are incinerated in a wood burner. Your firm’s representative asked our investigator why such a practice was problematic.
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