We recently posted an overall summary of the new draft PIC/S Data Integrity Guidance document (here). While this valuable Guidance document covers much of the same ground as previous Data Integrity Guidance documents from other regulatory agencies, it is particularly noteworthy that in several areas it provides detailed practical requirements heretofore never provided in a regulatory agency Guidance document.

One of the critical areas of Data Integrity where clear and useful guidance has been provided in this new document is on Data Review. Data Review is one of the most important tools available to ensure the reliability and accuracy of pharmaceutical data. Referring to the risk management principles described in ICH Q9, the Guidance states:

“The regulated user should perform a risk assessment in order to identify all the GMP/GDP relevant electronic data generated by the computerised systems. Once identified, this critical data should be audited by the regulated user and verified to determine that operations were performed correctly and whether any change (modification, deletion or overwriting) have been made to original information in electronic records. All changes must be duly authorised. The review of data-related audit trails should be part of the routine data review within the approval process.”

 The Guidance provides further details regarding the roles and responsibilities for data review:

“The frequency, roles and responsibilities of audit trails review should be based on a risk assessment according to the GMP/GDP relevant value of the data recorded in the computerised system. For example, for changes of electronic data that can have a direct impact on the quality of the medicinal products, it would be expected to review at each and every time the data is generated.”

Therefore, the Guidance is requiring the review of data-related audit trails associated with each batch of medicinal product that is produced and tested.

The Guidance goes on to indicate that firms should establish procedures describing, in detail, both how audit trails are to be reviewed and that the review activity should be documented and recorded. Further, the requirement for investigation of any significant variation detected during the review process and for a procedure that describes the actions to be taken if an audit trail review identifies serious issues that could impact the quality of the medicinal products are also presented. Finally, the Guidance calls for Quality Unit review of a sample of audit trail records during routine self-inspection programs.

The data review requirements proposed by the PIC/S Data Integrity Guidance documents are both practical and operational in nature, more so than most other pharmaceutical industry Guidance documents published to date. The approach recommended by the PIC/S document for data review is also consistent with the approach that Lachman has been recommending to its clients for the past several years. Only by employing an effective data review process as part of the release decision for every batch can the integrity of data be ensured.

For further information on the topic of data integrity in the pharmaceutical industry and the importance of taking a proactive approach, please contact James Davidson, Ph.D. at j.davidson@LachmanConsultants.com.