Last month, the EMA’s Good Manufacturing Practice (GMP) / Good Distribution Practice (GDP) Inspectors Working Group published their answers to 23 frequently asked questions related to Data Integrity and the Data Life Cycle. EMA’s Recommendations This Q&A document provides insight in the EU regulators’ expectations regarding data risk assessment and mitigation; data security, protection, and retention; electronic signatures; electronic data review; … Read more
Earlier this year, the FDA published draft guidance on Data Integrity and Compliance for GMP. And now PIC/S has published a new, draft document Good Practices for Data Management and Integrity to guide manufacturers of medicinal products in complying with GMP and GDP requirements. As a member of PIC/S, the US FDA participated in the development of this guidance. The draft … Read more
The FDA just published a new, draft guidance document on good manufacturing practices (cGMP) for drugs. This document is intended to address the frequent data integrity issues found during FDA inspection of pharmaceutical and API manufacturing sites. What’s new in this draft FDA guidance document: Clarifications & Definitions of Terms This draft guidance contains clarifications and definitions for the terms … Read more
In September 2015, the World Health Organization (WHO) published a draft guidance document focused solely on data integrity. This is due to recent increases in the number of inspection observations related to data management practices. These WHO recommendations are intended to ensure the integrity of both paper and electronic data and records. Share this with your team, so you can … Read more
