This new series of four articles takes a look at the UK’s Medicines and Heathcare products Regulatory Agency (MHRA) guidance for industry on data integrity. The focus of these articles is an interpretation and critique of the second version of the MRHA data integrity guidance for laboratories working to European Union GMP regulations, such as analytical development in R&D and quality control in pharmaceutical manufacturing. In doing so, some of the main differences between the first and second versions of the document will be highlighted and discussed.
Part 1: Overview
Topics in this introductory article include the global data integrity problem, drowning in integrity definitions and an overview of the MHRA data integrity guidance overview — setting the scene, and a discussion of the wrong definition of data and integrity criteria. There is a discussion of “1 in 28” member states of the European Union; why is the UK not coordinating with the rest of the European Union?
• Read Part 1: http://bit.ly/1eDIehP
Part 2: Data Governance System
In the second part, we look at the MHRA requirement for a data governance system — is there a basis for this when interpreting EU GMP Chapter 1? The main elements for a data governance system are presented and discussed — we also com- pare with an extreme example of a data governance system set up by a company following a consent decree with the FDA.
• Read Part 2: http://bit.ly/1eDIj4X
Part 3: Data Criticality and Data Life Cycle
This section of the guidance first looks at data generation: data integrity risk and criticality via different ways of generating data from observation to an electronic computerized system using electronic signatures. In addition, we consider the components of a laboratory data lifecycle and look at some of the issues surrounding this.
• Read Part 3: http://bit.ly/1FeFLzR
Part 4: System Design, Definitions and Overall Assessment
In this final part of the series, we look at the section on system design and discuss the key definitions that constitute the bulk of the guidance document. The series finishes with an overall assessment of the guidance document: the good parts and the poor parts.
• Read Part 4: http://bit.ly/1RvwETY
R.D. McDowall is Director, R D McDowall Limited. He may be reached at editor@ScientificComputing.com.