第15回DIA日本年会

The integrity of required scientific data and process records in ensuring the quality, efficacy, and safety of drugs has come under the spotlight. One major reason for this trend is instances of the alteration and falsification of data and records at a number of drug manufacturing sites. Steps such as access controls and review of audit trails are thus needed to stop intentional fraud, and the FDA has issued some warning letters in the last few years because of insufficient measures to ensure data integrity. Such factors have led to data integrity coming under closer scrutiny, with guidances issued for all GxP areas, not only GMP. In this session, we will discuss the main issues and what we can do to resolve them, taking a look at the latest regulations and recent inspection findings.