Are your records complete and accurate?

Good Documentation Practices, also known as GDocP, is an important function of Good Manufacturing Practices (GMPs.)  As the saying goes, “If it isn’t written down, it didn’t happen”.

According to our Annual Report on the top cited 483 observations during FY 2022, the top cited observation for pharmaceutical companies is not having written procedures and/or not following the procedures as written.

A company was cited for:

…. Documented records were found to contain incomplete or inaccurate information.

Specifically,

a.         The production operator admitted to recording the … weight checks on the production balance# … without performing all the documented tasks. The documented … weight checks with 50kg check weight was not physically performed for several months, however, the balance logs show recorded weights for 50kg check weight and verified by the 2nd person. Multiple personnel names are documented on the … balance calibration logs, performed by and verified by during the last several months.

b.         The signatures on the training records for QC chemist … do not match the signatures found on other training records and the employee’s signature card. The training records contained at least 13 signatures that did not match other signatures, found on five consecutive pages of the training records.

c.         There are no sampling logs to document all … samples collected from the water system. Any of the missing data points from the … trend data can’t be determined, whether the samples were not collected or not reported. … water trend report for … showed numerous gaps in reported results. Sample reconciliation could only be performed from the availability of the results data and the validity of the missing data points could not be established.

For more information on documentation practices refer to WHO guidance document, WHO Guidance on good data and record management practices. 

For information on how to set up standard operating procedures check out our Free download, “Creation, Approval, Distribution, Maintenance and Storage of Standard Operating Procedures.”

To view more observations pertaining to documentation, refer to the following GMP Trends® Issues:  1120, 1118, 1117, and 1116.

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