Wednesday, October 17, 2018

Warning Letter of the Week: results before observation edition

From a note from the Center for Drug Evaluation and Research to the President of Hanlim Pharm Co., Ltd. in Seocho-Dong, South Korea, this amusing comment:
3. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards (21 CFR 211.194(a)). 
Our investigator observed a quality control analyst and laboratory team leader signing and backdating a test record. In the microbiology laboratory, we also observed an analyst recording microbiological test results from environmental monitoring settling plates before reading the plates, as well as recording results for a previous day. Upon questioning by our investigator, the analyst stated the plate count data had been mistakenly omitted. CGMP activities must be documented at the time of performance. 
If you know the result beforehand, what's the harm? (for the record, that's a joke) 

2 comments:

  1. Boss: These aren't the results I expected.

    Chemist: Well, boss, what do you want them to be?

    ReplyDelete
  2. Many of the results are SF (Strawberry Fields) - nothing is real.


    ReplyDelete