The Pharmaceutical Industry Association of Puerto Rico (PIA-PR) hosted the 16th FDA Regulatory Conference with nine speakers that presented top priorities for pharmaceutical manufacturing across the globe, new technologies as voice recognition and how to effectively transition from paper to mobile, among other key topics.
The meeting kicked off with a recognition to Puerto Rico employees. Alonza Cruise, director of the Federal Drug Administration’s Office of Pharmaceutical Quality Operations (OPQP), said FDA is committed to Puerto Rico which “remains strong and we will continue to partner and help the (local) industry.”
Cruise pinpointed to the importance of the Mutual Recognition Agreements (MRA) with European Union (EU) members and how a new Site Selection Inspection List (SSIL) is working. The FDA scope of work, which includes assessment of 28 EU member states, have already assessed 14, and now they can accept each other for surveillance inspections. The SSIL risk model is helping FDA do more reviews, and they are increasing the size of the assessment teams for surveillance inspections.
Lieutenant Commander John W. Diehl, compliance branch director of FDA’s OPQP, Division II, stressed the importance of data integrity. For him “quality control is the gatekeeper. You need to ensure that products meet specifications. Do testing yourself. Don’t rely on previous tests. Evaluate your suppliers.”
Diehl presented details on a new FDA’s “ORA Program Alignment,” implemented in 2017 that changed from geographical to a program-base structure for FDA’s employees to specialize in a particular commodity and better respond to today’s challenges. “We are still in infancy, but we need to keep pace with the industry and technologies. We are learning more to be in tune with what you (pharmaceuticals) are doing.”
Rod Hoffman, senior business analyst at AstraZeneca Pharmaceuticals, presented a voice directed technology case study from a manufacturing plant in Australia. Hoffman said this improvement have helped them achieve a right-first-time approach, more efficiency, data integrity and are perceiving less distractions from operators.
The technology from Honeywell known as Vocollet is able to pass real time and textual instructions to operators’ headsets for them to confirm step by step voice responses, and send the information to a PAS/X platform, which remains as the primary and only electronic record since No data is stored in the Voice solution.
David Twohig, a partner in Enterprise System Partners, presented the transition from paper to electronic batch record. He outlined the steps needed: From paper to parameter classification (what is really important) to business risk assessment (focus