Data Integrity Working Group

PROBLEM STATEMENT  

Data Management and Control (referred to collectively as “data integrity”) are required as integral parts of the GxP environment. All GxP activities performed must be recorded; accurate, complete and consistent. Data is commonly used as source data for regulatory filings and expectations for data security and accuracy extend from the original data through to its reported interpretation. With these expectations, how does the level of control and oversight align with normal development timelines, for example, is the same level of data management and control required for early pre-formulation analytical studies as that required to support primary stability studies or does the level of oversight mature as studies transition from early pre-development through GLP to commercial GMP. 

 

MISSION/OBJECTIVES

Identify and define acceptable data integrity practices within industry regarding GxP expectations in early development that allow for appropriate flexibility and are consistent with existing guidance's and statutes. Identify and define the progression of data integrity expectations that is aligned with the maturity and knowledge of developmental studies and required to support CMC documentation. White Paper to complement 2012 IQ 5 part Pharmaceutical Technology series.