FDA Guidance on Data Integrity: A Must Read for All GMP Facilities

Data quality and integrity issues are the most common reasons for 483s and Warning Letters. Many of these arise from misunderstanding FDA’s expectations from common issues related to data and documentation generation, correction, and storage. This week FDA released a new guidance on a Q&A format that discusses most common issues that all GMP facilities must review to appreciate FDA’s expectations from data related issues. The guidance contains 18 questions commonly asked by auditees on FDA inspectors. Although the questions are not organized in any particular fashion, they address issues related to practically all aspects of quality control, computer systems, out of specification observations, deviation management, and risk management. The document provides perspectives and potential solutions for all issues discussed. This is one of a few guidance documents that are specifically designed with the intent to reduce audit findings and should be a must read for all GMP personnel.