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Volker Roeder
Volker Roeder
Home | FDA Guidance — New Document Published for Data Integrity & cGMP
May 17, 2016

FDA Guidance — New Document Published for Data Integrity & cGMP

The FDA’s new Draft Guidance is its response to the increase of data integrity violations registered by the regulatory authority over the last years within the framework of cGMP inspections. On many occasions, it sanctioned manufacturers of pharmaceuticals by issuing warning letters or import bans. Last year, the British supervisory authority MHRA published the GMP Data Integrity Definitions and Guidance so hotly debated in the industry. In March of this year, the industry association ISPE also voiced its opinion on corporate data integrity by means of its concept paper. With the new Draft Guidance, the FDA is now also underlining the high priority of data integrity for US American inspections.

The “Guidance for industry” is not legally binding. The recommendations, however, reflect the current expectations of the authority in terms of manufacturers of pharmaceuticals with regard to data integrity in the production process.

From a content point of view, the document is divided into two key sections:

  • Detailed reference to data integrity requirements in 21 CFR 211, 21 CRF 212 and to the principles concerning electronic signatures and records as per 21 CFR Part 11.
  • Recommendations on ensuring data integrity in a question and answer format, starting with definitions for relevant terms such as data integrity, metadata and audit trail

In the Guidance, the FDA answers a total of 18 questions and answers, including the following questions:

grity and CGMP Compliance


The “Data Integrity and Compliance with cGMP for Industry” Draft Guidance offers an excellent summary of applicable US American GxP requirements in the area of cGMP data integrity and electronic records. For assessing the current inspection practices, we also recommend reading Warning Letters and Problem Reports (Form 483) published by the authority in the last two years as regards data integrity.

Click here to view the full FDA Draft Guidance for Data Integrity and Compliance with cGMP.