Data Integrity in Good Manufacturing Practice

Pharmaceutical quality systems rely on data integrity to ensure that medicines through GMP Packaging for the highest quality.  A robust data governance strategy will ensure that data is accurate, complete, and consistent, regardless of how it is generated, used, or retained.

Assuring the quality and integrity of data

Across all aspects of the quality system, a mature data governance system employs 'quality risk management. Continuous review, proportionate measures of risk reduction, and an understanding of residual risk throughout the organization are required. It is important to remember ALCOA regarding data integrity. Data should be attributed, legible (permanent), contemporaneous, original, and accurate. 

Attributable:

A record should clearly identify the person who completed it. An individual should be permitted to use aliases or abbreviated names only if they are consistently used. Tried-and-true aliases or IT system logins that cannot distinguish between different individuals should not be used.

Legible (permanent):

Securing the audit trail is imperative to ensure that original records can't be altered or recreated without the audit trail. Paper records should not be overlooked either. Additionally, blank forms for manual data entry should be controlled in a manner that prevents unauthorized re-creation.

In some cases, it may be necessary to re-create a record. Quality Assurance must be overseen in all cases, and justification must accompany the approval. GMP areas do not accept correction fluid. Companies may have no idea that 'data annotation tools are available on their computer systems. 

Contemporaneous:

Record keeping contemporaneously is significantly affected by system design. The availability of records at the right time and place eliminates the need for staff to reuse loose scraps of paper or their memories to retain information for retrospective completion of the official record.

In this case, the staff in the primary packing area cannot make contemporaneous records, and vice versa, if the BPR is located in the secondary parking area.

Original:

A record's accuracy, completeness, meaning, and content must be preserved. To achieve this goal, metadata is essential, as it provides information about what was done, where, and when. .Pdf, .doc, etc., are examples of "flat files," which do not retain the complete metadata record. As a result, flat files pose an inherent greater data integrity risk since they are easier to manipulate and delete as a single record with little opportunity for detection.

Accurate:

Using automated data capture, with the required IT controls, gives you greater control over your records' accuracy. When automation of quality-critical observed values is not possible or feasible, real-time verification by a second operator may be required.

During data review, raw data must be viewed in its original form. Reviewers may be able to escape the confines of their office if they can't access electronic raw data remotely.  

Conclusion

The compliance with FDA's data integrity standards safeguards patients' safety by following GMP Packaging, but also prevents serious financial consequences, including facility closures, product recalls, import and/or distribution bans, Drug approvals have been delayed or denied, remediation costs have been high, and customers have lost trust.

If you want more interesting knowledge about Good Manufacturer Practice on our blogs Current Regulations on the Good Manufacturing Practice(GMP)