Data Integrity - Understanding And Becoming Compliant With GMP FDA Regulations

By Frank Panofen

Data integrity means data (such as from personnel or environmental monitoring) that is accurate, complete and repeatable, which in turn ensures the product's quality and public safety. In recent years, infractions relating to data integrity have been noted in several Food and Drug Administration (FDA) warning letters, but it is not a new concept. The importance of record-keeping in drug manufacturing can be seen as far back as 1938, when the Federal Food, Drug, and Cosmetic (FDC) Act required the safety of new drugs be documented before being sold to the public, with similar regulations instigated in Europe and Japan throughout the 20th century¹.

Production systems have large, inherent operational risks and are difficult to validate. Instead of only being reactive to public health disasters, preventative measures, such as the requirement for proof of claims, are taken to lower their likelihood and propagate confidence in manufacturers.

Presence in Regulations

In the past few years, several FDA warning letters (483s) have been issued for data integrity deficiencies in the pharmaceutical industry. In 2016, more than 50% of MHRA warning letters involved data integrity lapses for computerized systems compared to the previous year.⁴ Inspectors are actively trained in data integrity requirements, and strongly enforce them for falsified batch records or discharging of raw data.

Understanding recent standards, guides and regulations pertaining to data integrity is essential to becoming compliant. Relevant documents include 21 CFR Part 11, MHRA: GxP, EU GMP Annex 1, the FDA Data Integrity and Compliance with cGMP, and the WHO Good Data and Record Management Practices. Inherent to data integrity compliance is the goal of increasing product quality, regulator confidence, brand reputation and process control while reducing product defects and costs. This applies to multiple areas of the pharmaceutical industry, including manufacturers of finished drug products for clinical trials, bioequivalence studies and commercial distribution, laboratories, contract manufacturing, suppliers etc.