Data integrity relates to any type of ‘data’, and the degree to which a collection of data is complete, consistent, and accurate. Data can exist in a variety of forms – as numbers or text on paper or as bits and bytes in electronic form. No single type of data is exempt from data integrity concerns, and such concerns have been part of a growing focus from regulators across pharmaceuticals and healthcare.1 Each regulatory agency has issued data integrity guidance, the most recent, at the time of writing, coming from the U.S. FDA which issued the document titled “Data Integrity and Compliance with Drug cGMP: Questions and Answers” in December 2018.2 In many instances data integrity is nothing new, with many of the principles and requirements stretching back to the 21 CFR Part 11 requirements of the late 1990s,3 but the regulatory expectations are certainly higher. This article assesses some of the data integrity implications applicable to cleanrooms, as used in GMP facilities. The main focus, as an illustrative example and given their centrality for cleanroom assessments, is with particle counters. Reference is also made to viable microbiological monitoring and other areas where cleanroom data is captured, such as the recording of room pressure differentials and gown usage.

Click Here For Complete Article Text

• Data

• Data Acquisition

• Data Improvement

• Regulation & Policy/Environmental Assessment

• American Pharmaceutical Review

• 3/21/2019

• Article