How to Deal with Data Integrity Woes: New FDA’s Guidance to Help
[Posted on: Thursday, 21 April , 2016]
Data integrity issues have plagued manufacturing sites in India for several years. Repeatedly GMP sites in India were found in violation of documentation practices, data manipulation, data omission, and other issues that raise major issues about reliability of data. Although sites in India are not alone in data integrity issues but arguably sites in India received more than their fair share of negative FDA audit findings because of data integrity issues. It seems FDA’s new Guidance Document on Data Integrity released this week specifically lists the key findings and solutions from this experience. The main purpose of the guidance seems to provide clear and precise solutions to common issues in a question and answer format. It starts with key definitions and then systematically addresses critical issues such as inclusion or exclusion of data from decision making process, access control, validation of data, good documentation practices, audit trails, electronic and paper raw data, training, ways to handle data falsification, and scope of an FDA audit of data. Each issue is explained with specific examples and provides clear instructions on FDA’s expectations. It may seem that the guidance goes beyond what is described in the regulations, however, to experienced GMP professionals and auditors it provides a clear measure against which to verify the status of compliance of a given organization. Some key takeaways are that all data, whether used in decision making or not, needs to be available in its original form for review by QA; access needs to be controlled to attribute each data element to a given individual; systems need to be protected to prevent changing of data once generated; and data breaches to be investigated and resolved. FDA recommends independent audits for verification and strict action against all personnel found to be responsible for data manipulation. The document establishes criteria for verification and measures to assign liability for errors.
Although the Guidance Document is remarkable in the clarity of explanation and examples used to highlight the key issues, it does not create new requirements. Although the document does not name any specific violators, the issues raised and examples used are very similar to those listed in Warning Letters and FDA 483s given to several GMP sites in India. Reading the document gives a feeling like FDA is trying to tell past violators what good responses should have looked like. The irony is that the solutions provided are very logical and common sense should have dictated these to be standard answers already. The fact that FDA had to create a guidance document like this indicates FDA’s frustration at repeat occurrence of such violations in multiple sites. The principles applied for good documentation practices at GMP as highlighted in this guidance are applicable to GCP and GLP organizations as well and hopefully it will be used universally for all compliance areas.