Data integrity breaches continue to challenge the pharmaceutical industry, but regulatory agencies and industry are partnering together to raise awareness and solve these issues.
Over the past two years, pharmaceutical manufacturers operating in India have received over twelve U.S. FDA warning letters alleging, in part, deficiencies related to data integrity. As a result of the continued struggles with data integrity in this market, the FDA partnered with the Drug Information Association to host a Multicentre International Data Integrity Workshop, a series of conferences aimed at increasing the knowledge of manufacturers to identify and resolve these issues.
In an effort to demonstrate a unified approach and to assist in promoting an open dialogue, the hosts worked with PDA, the Indian Drug Manufacturers’ Association, the Organisation of Pharmaceutical Producers of India, and industry to present the two-day workshop at three cities across India during the first two weeks of November 2014. The target cities were Mumbai, Hyderabad, and Bangalore based upon their geographic locations and due to the number of manufacturers in those areas. The response was overwhelming as small and large companies signed up to attend.
The first session began with opening remarks by Peter Baker, Assistant Country Director, FDA India Office, to introduce the workshop and set the stage for the remaining discussions. Baker informed the audience of the top areas of concern for data integrity, which include quality control inspection and testing, batch records, equipment qualification and use, and training. He discussed the importance of documentation, but stressed that the data is much more important and added that industry should focus on their daily practices.
Carmelo Rosa, Division Director of Office of Compliance, Office of Manufacturing and Product Quality, CDER, FDA, provided a solid background on data integrity and made the case for change by highlighting the number of data integrity warning letters issued by FDA and stressing the importance of global corrective actions. He emphasized that this issue is not only found in India, but is an industry-wide issue. Rosa informed the group of FDA’s emphasis on responses to issues identified in an inspection and their expectation of implementing systemic corrective and preventive actions.
As data integrity is not only an issue for the U.S. market, Thomas Hecker, PhD, GMP Inspector, EDQM provided the group with a European perspective based upon regulations, standards, and guidance documents. Hecker’s presentation highlighted applicable sections of 21 CFR Part 11, EU GMP Annex 11, and ICH Q7 and how the three documents can work together to meet regulatory agency expectations.
While data integrity covers a broad topic in both electronic and paper form, Robert Tollefsen, National Expert Investigator, Drugs and Computers, Office of Regulatory Affairs, FDA, focused on validation, collection, and storage of electronic data in his presentation. He provided attendees with an overview of the requirements for a successful validation. In his second presentation, Tollefsen discussed the importance of management, culture and oversight in not only identifying and correcting data integrity breaches, but in prevention.
Industry presentations by Hospira, Johnson & Johnson, and Novartis provided the audiences an opportunity to hear from their peers. Meera Khullar, Vice President, Quality, Hospira, presented on the development of an operator and analyst training program. Her presentation went beyond data integrity into the elements of a successful and compliant training program.
Anil Sawant, Vice President, Enterprise Regulatory Compliance, Johnson & Johnson, presented on establishing a management culture that goes beyond the identification and correction steps and into the proactive process of prevention.
Novartis representatives Mairead Goetz, Head of Compliance, Group Compliance and Audit, presented in Mumbai, Sudhir Goudar, Regional Head APAC, Group Compliance and Audit, presented in Hyderabad, and C. Gregory Williams, Head of Audit, Group Compliance and Audit, presented in Bangalore, on the topic of internal audits and how companies can establish their programs to identify data integrity issues. The presentations highlighted how to establish an audit program.
Three interactive workshops were conducted covering establishment of an effective training program, establishing an effective audit program, and establishing a data integrity risk analysis process. The workshops required all the attendees to participate in small work groups and then report to the larger group about their findings.
The success of these workshops highlighted a strong collaboration between regulatory agencies and industry. Baker stated that, based upon that success, additional workshops will be planned in the future. Protecting against breaches of data integrity is not only a hot topic with the FDA today, but forms the basis by which industry protects our patients in providing safe and effective medicines across the globe.
About the Author
C. Gregory Williams is active in various industry groups, including PDA, AAMI, and Rx-360, and is currently the Head of Audit in the Group Compliance and Audit department of Novartis.