Submitting Regulatory Applications Connects to Quality

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice president, Technical at Parexel, discuss submitting biologics license applications and working with suppliers. These two topics have a few things in common, most importantly common steps to ensure product quality.

“[The] best way to make sure that you're giving [FDA] what they need is to really talk with them. I think calling up the center, getting your advocate, [and telling them] here's what I'm intending to file early on in your process is where you need to be to understand. Because I would think that this is geared towards not a more common biological but more of a novelty,” says Schniepp in the episode.

Schmitt agrees with getting clarification and addressing gaps in knowledge. “Now, of course, you can ask the agency. [Hopefully you have] some in-house expertise, but again, it is sensible to understand. Where are the gaps? Where would you perhaps need external expert support? [And] as we said with all the other questions before, you need to have a quality system that makes sure that whatever external support [you choose], you select those who are most suitable for your needs and can provide you with some quality expertise.”

Click the video above to watch Sue and Siegfried answer the following questions:

• “My company is preparing a BLA to provide to FDA for approval. How can we be sure we’ve given the agency everything it needs?”
• “How do I assess the quality culture of a current or new contract provider?”

Important terms and acronyms

BLA—biologics license application

ICH—International Council for Harmonisation

WHO—World Health Organization

This week's experts

Susan J. Schniepp is distinguished fellow at Regulatory Compliance Associates and a member of Pharmaceutical Technology®'s Editorial Advisory Board.

Siegfried Schmitt is vice president, Technical at Parexel and a member of Pharmaceutical Technology®'s Editorial Advisory Board.

Ask the Expert Video Series

Welcome to the Ask the Expert video series. This series is an extension of the PharmTech Group’s long-running print column in which industry experts answer common quality and regulatory questions from the industry. This new video series will expand on topic areas to include development and manufacturing concerns to help those working in the industry better understand bio/pharmaceutical requirements. Have a question you would like answered? Send it to PTProjects@mmhgroup.com, and it may appear in a future episode or print column.

We hope you enjoy the discussion!