Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to improve drug quality through vigilant oversight of datga integrity and good manufacturing practice (2018). FDA Statement December 12, 2018.

"This new guidance, Data Integrity and Compliance With Drug CGMP: Questions and Answers is an update to our 2016 draft guidance. The guidance covers the design, operation, and monitoring of systems and controls to maintain data integrity. The agency revised the guidance in response to public comments requesting additional details on our thinking on current best practices. The revised recommendations are aimed at helping manufacturers address identified data integrity lapses, implement best practices to address gaps that can create risks to data integrity, and ensure consistent awareness and commitment to ensuring data integrity. The principles are relevant to manufacturing employees and management."

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Data Integrity Resources - [UNDER CONSTRUCTION]

1. Data Integrity and Compliance With Drug CGMP: Questions and Answers - December 2018,   read it here.
2. Data Integrity and Compliance With CGMP - April 2016, read it here.
3. Data Integrity (EMA - August 2016), read it here.
4. PIC/S Guidance - Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments - November 2018, read it here.
5. Guidance on Good Data and Record Management Practices. WHO Technical Report Series, No. 996, 2016, Annex 5, read it here.
6. MHRA GMP Data Integrity Definitions and Guidance for Industry March 2015, read it here.