Good Document Practices


Good Document practices are required by subpart J of 21 CFR 211.  The agency expects firms regulated by 21 CFR 210 and 211 to follow good document practices as this is the evidence that the API or Finished Pharmaceutical meets the Safety, Identify, Strength, Purity and Quality levels required of the cGMPs.

A few days ago I blogged about breaking the compliance cycle of inspection, remediation, re-inspection and the seeming never ending quality failures of some manufacturers.  If there is a systemic lack of compliance within the company should they remain in business, should their leadership and management remain in control? Can they effectively pivot and change the company culture overnight to a culture based on compliance?

If you want to read what not to do in maintaining Good Document Practices, take a read through a recently posted FDA Form 483 from a December 2016 inspection at an India oral solid dose Drug manufacturer.  The 13 page, 8 observation has a litany of examples of poor document practices.  According to the 483, the firm installed a shredder in the firm’s document control center 4-days before the FDA inspection and through review of the company’s closed circut TV the FDA identified the firms employees shredding documents.

There is more… Various controlled documents were found in the trash bin outside one of the buildings, a postdated balance report.  A shredder in the QA portion of a building with shreds of what appeared to be raw data with original QA and QC signatures.

The obvious question that arises from inspection reports such as this; will the firm leadership and management learn from and change the organizational culture of the firm?  Will they communicate and inforce that this type of behavior does not reflect a compliance culture.  Or will this simply result in window dressing and yet another follow up inspection with similar findings?