In a time that we find ourselves so busy, who has time to attend a conference? That was my initial thought, but when asked to speak at the conference, it became clear that this would be a unique opportunity to better understand the regulatory landscape while surrounded by members of India pharma and in the presence of key FDA regulators. The meeting was co-chaired by Carmelo Rosa, PsyD., Director, Division of International Drug Quality, FDA/CDER, and Frances Zipp, President and CEO, Lachman Consultant Services. For three full days, the packed audience heard from the FDA and pharmaceutical industry experts as they discussed basic quality systems and ICH Q10. The conference delivered sessions focused on manufacturing, regulatory landscape, validation, emerging technologies, native culture, and data integrity both in the laboratory and in the manufacturing cycle. The audience, presenters, and regulators engaged in very candid, open, transparent discussions. A largely Indian audience was quite responsive, asked many questions, and remained sincerely engaged during the entire conference.
Day Three of the conference was focused on cultural issues with an emphasis on regulations and the regulatory process becoming sustainable within the culture of India pharma. There were numerous frank discussions regarding overall behavior at all levels of the organization, from the shop floor to the executive level. One of the presenters remarked that subordinate behaviors have deep roots in Indian culture. This impacts all aspects of pharmaceutical manufacturing. The awareness of these behaviors and the underlying cultural norm was well received by the audience (and included standing applause).
The regulatory and industry experts presented many interesting topics; of note was the emphasis on data integrity (DI) beyond the laboratory application. DI is a concern in all levels of the manufacturing cycle, from development through clinicals, and on to submissions and commercial manufacturing. While the DI issues are similar, the framework beyond the laboratory is different. The detection and remediation of issues signaling DI vulnerability throughout the manufacturing cycle will require new thinking, expertise, processes, and technology to understand and help alleviate these concerns.
