Data Integrity requirements for Pharmaceuticals

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 to be the focus of many GMP inspections.

As a consequence international authorities - FDA, EMA, PIC/S, WHO, MHRA - published draft and final 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. The learning objectives are firstly, understand the data integrity requirements of a GMP regulated laboratory in pharmaceutical organisations and contract labs and secondly, how laboratory personnel can ensure compliance and be able to defend their positions.

Second person review is a critical process that needs to be thorough and effective to ensure that data issues are picked up and resolved. Hence, this course is designed in such a way that, the students will understand basics in data integrity and audit trail review, further they will understand very small difference between good documentation Practices requirements and data integrity requirements. There is specialised session to focus the data integrity requirements for analytical laboratories and Microbiology laboratories.

Note that this course will focus only on hybrid and electronic systems and will not consider paper-based data integrity.