FDA & Data Integrity
Robert Marohn, Director of Quality Business Systems, Kite Pharmaceutical01.25.19
On December 13, 2018 the U.S. Food and Drug Administration (FDA) released the final version of its guidance released the final version of its guidance titled, “Data Integrity and Compliance with Drug CGMP: Questions and Answer.”1 The guidance is preceded by a statement released a day earlier from FDA Commissioner Scott Gottlieb, M.D., on “…the agency’s efforts to improve drug quality through data integrity and good manufacturing practice oversight.”2
The guidance and statement place an exclamation point on FDA’s focus on “ensuring data associated with drug manufacturing are complete, consistent, and accurate, and therefore reliable,” as emphasized by Commissioner Gottlieb. This article looks at the important elements of FDA’s final data integrity guidance, its impact to contract pharmaceutical organizations, and notable updates from FDA’s draft version of the guidance.
While FDA expects all data to be reliable and accurate, the introduction of the final guidance emphasizes that firms should “implement meaningful and effective strategies to manage their data integrity risks based on their process understanding and knowledge management of technologies and business models.” For more information on risk assessment and analysis, see Contract Pharma’s September 2017 feature, “Data Integrity: A Practical and Risk-Based Approach.”3
The guidance and statement place an exclamation point on FDA’s focus on “ensuring data associated with drug manufacturing are complete, consistent, and accurate, and therefore reliable,” as emphasized by Commissioner Gottlieb. This article looks at the important elements of FDA’s final data integrity guidance, its impact to contract pharmaceutical organizations, and notable updates from FDA’s draft version of the guidance.
While FDA expects all data to be reliable and accurate, the introduction of the final guidance emphasizes that firms should “implement meaningful and effective strategies to manage their data integrity risks based on their process understanding and knowledge management of technologies and business models.” For more information on risk assessment and analysis, see Contract Pharma’s September 2017 feature, “Data Integrity: A Practical and Risk-Based Approach.”3
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