Welcome to Insider issue #27.
And a very warm welcome to the 582 new life science professionals who joined last month. If you haven’t already upgraded to a paid subscription to unlock our in-depth analysis issues like this one, you can do so here.
In our pharma feature, we explore the FDA's increased use of Remote Regulatory Assessments (RRAs) for low-risk manufacturing facilities. This initiative, part of the FDA's Pre-Approval Inspection program, leverages remote assessments to maintain regulatory oversight while streamlining the approval process. We cover key factors the FDA considers when choosing between on-site inspections and RRAs and offer practical recommendations for manufacturers to prepare for these assessments.
Our device/medtech feature highlights the FDA’s updated draft guidance on the Q-Submission program for medical device submissions. This guidance provides a comprehensive overview of how companies can request feedback and meetings with the FDA, clarifies the scope of Q-sub types and offers detailed recommendations for effectively navigating the submission process.
Lastly, our warning letter breakdown examines a recent FDA warning to a Jordanian pharma firm for significant violations at its manufacturing facility. The letter highlights critical deficiencies in facility design, aseptic processing, environmental monitoring, data integrity, and quality control. We distill the major violations and provide actionable lessons for quality teams to enhance compliance and prevent similar issues.
A big thanks to this month’s expert contributors, Jesse Hart, MSOPM, Dharmesh Patel, PMP, GWCPM, CSSGB, and Judson Russell.
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