Verification of lab data is a crucial aspect of ensuring compliance with established specifications and standards, as outlined in CFR section 21 CFR 211.194(a)(7).
This regulation states that laboratory records must include complete data derived from all necessary tests, including examinations and assays, along with the initials or signature of the person who performs each test and the date(s) the tests were performed.
A recent FDA inspection of a company revealed a pitfall related to two different analysts using the same login credentials for an HPLC machine. This issue made it impossible to trace back which analyst performed which part of the test, as there was no way to identify the unique individuals responsible for the HPLC runs.
The FDA observation stated:
“Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.” Specifically, the HPLC machines used in the testing of pharmaceutical drug products did not have individual assigned sign-on for each analytical chemistry technician or manager using the specified instrument to complete an HPLC run. Within the last two years, tests were conducted on pharmaceutical drug using these HPLC machines, but unique individuals could not be identified through the login. Additionally, several HPLC runs were completed under the credentials of employees who were no longer with the firm.
It is imperative that HPLC software allows for individual login credentialing for each analyst, along with time stamps and an audit trail of the actions performed. The same company had further observations related to the HPLC machines, where data was stored on individual machines, making it susceptible to being overwritten or deleted.
Ensuring proper access controls and data integrity is crucial in maintaining compliance with regulatory requirements and ensuring the accuracy and reliability of laboratory data.
With access to GMP Trends yearly subscription, read analysis of FDA 483-Observations and empower employees’ daily work and quality efforts with actionable information. Schedule a demo of the GMP Trends platform today.
To view more observations pertaining to laboratory controls, refer to the following GMP Trends® Issues: 1040, 1041, 1044 and 1048.
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