FDA announced on 15 April 2016 that it had issued draft guidance for industry on data integrity and compliance with current good manufacturing practices (cGMP). The guidance is open for comment for a period of two months. 

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the World Health Organization (WHO) have also recently drafted guidance documents on data integrity and good data and record management.

FDA has increasingly observed cGMP violations involving data integrity. This, the agency says, ‘is troubling because ensuring data integrity is an important component of industry’s responsibility to ensure the safety, efficacy and quality of drugs’. It adds that ‘these data integrity-related cGMP violations have led to numerous regulatory actions, including warning letters, import alerts and consent decrees’.

India-based Ranbaxy Laboratory (Ranbaxy) – now owned by Japan-based Daiichi Sankyo – was banned from supplying drugs to the US after numerous GMP violations were found at three India-based facilities. The violations led to a consent decree being signed in 2012, which cost the company US$500 million [1]. But Ranbaxy is not the only one, FDA has issued numerous warning letters and import bans to Indian companies [2-4]. Chinese active pharmaceutical ingredient (API) maker Zhejiang Hisun Pharmaceutical is also still under an import alert, which was initiated in September 2015 due to data integrity problems [5].

FDA’s draft guidance aims to reduce future problems by helping the pharmaceutical industry ensure data is consistent and accurate. It consists of 18 questions and answers addressing the quality of data, controlling access to data, audit trails and back-up of data, as well as how the FDA recommend data integrity problems be addressed.

Data Integrity and Compliance with CGMP
Date: April 2016
http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm495891.pdf

Comments and suggestions regarding the draft guidance should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance, i.e. from 15 April 2016. Electronic comments can be submitted to www.regulations.gov and written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

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References
1.    GaBI Online - Generics and Biosimilars Initiative. Ranbaxy consent decree with FDA submitted to court [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 May 6]. Available from: www.gabionline.net/Generics/News/Ranbaxy-consent-decree-with-FDA-submitted-to-court
2.    GaBI Online - Generics and Biosimilars Initiative. FDA issues more warnings to Indian firms [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 May 6]. Available from: www.gabionline.net/Policies-Legislation/FDA-issues-more-warnings-to-Indian-firms
3.    GaBI Online - Generics and Biosimilars Initiative. FDA issues warning letters to Indian firms [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 May 6]. Available from: www.gabionline.net/Policies-Legislation/FDA-issues-warning-letters-to-Indian-firms
4.    GaBI Online - Generics and Biosimilars Initiative. Further problems for Indian manufacturing sites [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 May 6]. Available from: www.gabionline.net/Policies-Legislation/Further-problems-for-Indian-manufacturing-sites
5.    GaBI Online - Generics and Biosimilars Initiative. FDA lifts import ban on Chinese API to prevent shortages [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 May 6]. Available from: www.gabionline.net/Generics/General/FDA-lifts-import-ban-on-Chinese-API-to-prevent-shortages

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