Data integrity continues to be a top observation during FDA inspections, with many observations leading to significant regulatory actions (warning letters, import alerts, and consent decrees). To help companies comply with expectations, the FDA has issued a new guidance document. The guidance cites the specific requirements for data integrity from 21CFR parts 210, 211, and 212. While the requirements of part 211 and 212 apply to finished products, the agency notes that these requirements are also consistent with guidance on active pharmaceutical ingredients. The guidance is presented in a Q&A format which allows the guidance to address specific questions that are related to the most frequent inspection findings. The transition from paper-based to electronic systems has created confusion about the application of specific regulations to the electronic system, and this guidance covers many of those areas with detailed commentary. This guidance is long overdue and should be used to trigger risk assessments and gap analyses in every organization following cGMP requirements.

Text Copyright © 2019 Katrina Rogers