Last week, the U.S. Food and Drug Administration (FDA) issued a Draft Guidance addressing Data Integrity. The guidance, entitled Data Integrity and Compliance with CGMP, Guidance for Industry, is styled as a series of questions and answers, reports Jim Johnson of Hogan Lovells. He adds that it is the first guidance document the FDA has issued specifically concentrating on Data Integrity.
According to Johnson, while the guidance does not cover every issue companies may face with regard to Data Integrity, it does provide some initial insight into what FDA expects to see during an inspection.
Johnson has prior FDA experience, serving as an Associate Chief Counsel in the FDA's Office of the Chief Counsel from 2005 to 2011, where he prepared and brought numerous FDA enforcement actions based on complex GMP deficiencies, labeling violations, and unapproved new drug charges.