Wednesday, February 5, 2020

Warning Letter of the Week: scraps of paper edition

In a letter to the general manager of Sunstar Guangzhou Ltd. in Guangdong, Guangzhou, China from the Center for Drug Evaluation and Research, this amusing tidbit:
4. Failure to establish an adequate quality control unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. (21 CFR 211.22(a) and 211.22(d)). 
Your quality unit (QU) failed to ensure that you have adequate procedures and did not provide adequate oversight of your manufacturing activities. For example: ·
  • You lack adequate control over the issuance, use, and reconciliation of manufacturing batch records and equipment maintenance sheets. Uncontrolled copies of manufacturing batch records and in-process control forms were pre-printed and kept in a room with unrestricted access.
  • Several test reports of your drug product assay were reviewed and the raw data for the standard curve could not be located. It was noted that scrap pieces of paper were used to record data which was later entered to calculate the [redacted] concentration for the assay test.
  • Your firm failed to establish and follow procedures for calculating production yields.
In your response, you stated" ... starting July 2019, relevant personnel will be handed just enough blank forms on a [redacted] basis and they must account for the whereabouts of all blank forms at the [redacted]." You stated that all documents will be archived and procedures will be drafted and/or updated to meet CGMP requirements.
"Scraps of paper" may have described some of my grad school jotted notes, but definitely not my experience in a QC lab...


  1. Employees of Guangzhou Ltd should take advantage of the coronavirus. Wear surgical masks when auditors come around. Cough frequently. Moisten your thumb and index finger with the tip of your tongue when sorting through papers to give to the auditors. Have employees sign a sympathy card for a deceased person who died from the coronavirus.

  2. The first time I worked in a lab (summer school, before senior year), I wrote lots of data on Post-It notes. After that, I recognized that that was not a good idea.

  3. The CFR states you can document on scrap paper if it is original data, but the scrap paper must be kept with the batch records.

    In the manufacturing areas of my company, scrap paper and post it notes are banned per company policy though.


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