3. Failure of your quality unit to exercise its responsibility to ensure the API manufactured at your facility are in compliance with CGMP, and meet established specifications for quality and purity.
Our investigators found batch production records that contained blank or partially completed manufacturing data and lacked dates and signatures for verification. For example, in your [redacted] plant, our investigators found a batch record for [redacted] starting material, batch [redacted], with sticky notes from the quality assurance department directing operators to enter manufacturing data, such as missing weight and volume entries. Also, your quality unit did not approve this batch record before the material was used in further manufacturing.
All data in CGMP records must be complete and reliable so it can be evaluated by the quality unit during its batch review, as well as maintained for additional CGMP purposes.
Other documents—including cleaning records and equipment use logs—were also found to be partially completed, without dates and signatures for verification, or with pages or spaces intentionally left blank for documentation at a later time.
Your quality unit was aware of these unacceptable production department practices but did not ensure they were corrected.
Wednesday, June 21, 2017
Warning Letter of the Week: Sticky notes edition
A short epistle from the Center for Drug Evaluation and Research to Mr. Jun Wu, the Chairman of China Resources Zizhu Pharmaceutical Co., Ltd.:
It's interesting to see what CDER is pointing out, i.e. that the quality unit wasn't stopping the production of the material; rather, it looks like the material was pushed forward, and the batch records were never filled out before the inspectors arrived.
The checking of batch records by QA (and the properly-documented correction of such) is such a routine part of cGMP production, but it's easy to take it for granted.