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Applying FDA's Final ICH Q13 Continuous Manufacturing Guidance, Preparing for October's eSTAR Requirement + Warning Letter Breakdown

We take a close look at FDA's final Q13 continuous manufacturing guidance, explore eSTAR preparation before the October requirement, and draw GMP lessons from a recent Warning Letter.

Welcome to Insider issue #14.

And welcome to the 182 new life science professionals who joined last month.

This month, in the pharma space, we dive into the deep end of the International Council for Harmonisation (ICH) guidance on continuous manufacturing (CM) of pharmaceutical and biologic products. As the pharmaceutical industry braces itself to embrace this innovative manufacturing model, we bring you a comprehensive look into the benefits, challenges, and key considerations for a smooth transition from traditional batch manufacturing to CM.

In our device feature, we explore the FDA's commitment to improving the 510(k) electronic submission process, a move that's set to become mandatory by October 2023. We walk you through the ins and outs of the Electronic Submission Template and Resource (eSTAR) system, looking at its potential benefits, limitations, and critical points that your team needs to consider for successful submissions.

Lastly, our warning letter breakdown section analyzes a recent case of a US contract manufacturer of OTC products falling short of Good Manufacturing Practices (GMP). We dissect the specifics of this case to highlight key lessons that manufacturers can learn from to avoid similar compliance pitfalls.

We've also compiled a list of key self-assessment questions and action-planning tips to help you identify areas of potential improvement. For personalized advice or further assistance in any of these areas, feel free to get in touch with our team of expert consultants.

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