Data Integrity Master Class with full-day pre-course session Raw Data
Im Auftrag der ECA Academy

Pre-course Session "Raw Data"

FDA GMP in 21 CFR 211 requires “complete information” for manufacturing records and “complete data” for laboratory records. In contrast, Chapter 4 of EU GMP on documentation contains in the Principle three sentences that are in apparent contradiction to the United States regulations:

In the days of harmonisation of regulations how can we reconcile these differences? This situation is compounded by the failure of EU GMP to define the term “raw data” in the regulations to help industry plan their approach to meeting these regulatory requirements.

Data Integrity Master Class

Even Data Integrity is one of the basic GMP principles since years multiple Data Integrity citations were reported by FDA und European inspectors during the last 3 years. Many US Warning Letters and EU Non-Compliance Reports deal with serious Data Integrity violations. Data Integrity questions have been and will continue be the focus of many GMP inspections.

As a consequence international authorities – FDA, EMA, PIC/S, WHO, MHRA - published draft documents to describe  the regulatory expectations of  Data Integrity.

Although all guidelines are not intended to impose additional regulatory burden to the regulated companies, a lot of uncertainty predominates the pharmaceutical industry how to implement these requirements into the daily Business.