Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Assuring data integrity for CMC regulatory submissions using custom digital tools ***

Dr. Bernhard Richard (Abschlußjahr: 2024)

Summary
Language: English
The term 'data integrity' describes the expectation that communicated data for regulatory submissions are reliable, as they are the basis for manifold decisions of manufacturers and regulators that may affect pharmaceutical product quality, safety and efficacy. Potential data integrity breaches do therefore pose considerable risks for patients and have to be appropriately addressed by anyone concerned with pharmaceutical development and manufacturing.
Data integrity has to be maintained with appropriate measures, such as data integrity checks. Various tasks in the pharmaceutical industry, for instance in CMC management, do commonly deal with large and complex data of potentially heterogenous origin, which increases data integrity risks when data are manually and repeatedly prepared for regulatory communication. This issue can be addressed with programmed solutions, employing languages such as R.
In this work, the validation of R and custom digital (R) tools for data cleaning and analysis is discussed. The 'Custom R Tool Validation Framework' is proposed, which allows for assurance of data integrity, while rendering post-hoc integrity tests obsolete. Specific tools and templates provided in this work pair up with the Custom R Tool Validation Framework to jointly provide significant benefits in terms of maintaining data integrity, documentation and work efficiency. Their use is demonstrated and the underlying reasoning is discussed, along with their fit to the Pharmaceutical Quality System and the international pharmaceutical regulatory environment.
Pages: 95
Appendices: 2, pages: 20