PharmTech’s March issue will feature an update on process analytical technologies that will include a focus on validation. As part of my research for the March feature, I would like to know your answer to the following question.

How has the FDA process validation guidance, Guidance for Industry: Process Validation: General Principles and Practices, changed validation in pharmaceutical manufacturing?

Please send your answers to shaigney@advanstar.com or post them directly here in the comments section.

Thank you!

A new year has started in the world of pharmaceutical manufacturing and technology, and 2013 looks to bring plenty of innovation. PharmTech’s January issue highlights what the pharma industry can expect in the upcoming year.

Look for a discussion with FDA on the changing scope of regulatory science and its effect on drug reviews, site inspections, and approvals as well as academia’s role in the future of pharmaceutical manufacturing. We will also have a look at the future of CMOs and ISPE’s view on the future of the quality laboratory.

We would also like to know what you think the new year will bring! Please leave your comments on what your company’s goals and innovative projects are for the new year, and be sure to let us know what you would like to see us cover in the year to come!

Continuous manufacturing is now becoming a trend as its advantages are being increasingly recognized. At the PDA/EMA joint conference, which took place earlier this month, Martin Wunderlich from F. Hoffmann-La Roche presented an industry case study on solid drug product manufacturing based on this concept. He explained how a continuous wet granulation process for one of the company’s product (referred to as ‘product X’ hereafter) was developed using a quality-by-design (QbD) approach and a control strategy based on process analytical technology (PAT), as well as the technical challenges involved in the development of the process. Read more »

On the second day of the PDA/EMA joint conference, we had a choice of three different topics, all running simultaneously: GMP inspection practice, process and validation, and challenges for EU harmonisation. I somehow found myself listening to Lina Ertle from the French national agency for medicines and health products (ANSM), who gave an update on process validation guidelines. Read more »

How to optimize continuous processing and make it work in pharmaceutical manufacturing is a crucial issue. Real-time devices for continuous feeding processes, among many other topics, were discussed at a seminar I attended last week. The seminar, “Advances in Pharmaceutical Processing”, was sponsored by K-Tron, which supplies material handling and feeding systems. Read more »

Want to know what the future of pharma science looks like? AAPS knows. They recently awarded several graduate students for their work in research and development, pharma analysis, drug delivery, bio- and nano-technology, and more. PharmTech had the chance to talk with some of the winners and their stories appear in the December issue of PharmTech. You can get a sneak preview of the students’ winning research via a video podcast on PharmTech.com and the PharmTech Player.

The 2012 European Outsourcing Awards—what some call the “Outsourcing Oscars”—were presented on October 10, 2012 during the CPhI Worldwide/iCSE show and included awards to Vetter for a high-speed filling line and to Catalent for updates to its controlled-release facility. Read more »

The East Coast, including PharmTech’s offices, is largely boarding up and shutting down in preparation for Hurricane Sandy.  But the FDA is still keeping vigilant. Just before the weekend, on Friday, Oct. 26, 2012, FDA released a copy of a Form 483 issued to the New England Compounding Center (NECC), which has been under investigation for violating the Federal Food, Drug, and Cosmetic Act.

“The inspection report for NECC has not been completed and is not being shared at this time,” says the release. FDA is still working with the US Centers for Disease Control and Prevention and Massachusetts partners regarding fungal meningitis outbreak and those patients who received NECC’s compounded preservative-free methylprednisolone acetate (80mg/ml), an injectable steroid, according to the release.

For back story, see the video on PharmTech.com/PharmTechTV regarding the compounding center and its connection to the recent fungal meningitis outbreak.

The recent presidential and vice-presidential debates have highlighted the need for strategies for economic growth in the US, including the roles innovation and trade play in stimulating the US economy. Eli Lilly Chairman, President and CEO John C. Lechleiter recently weighed in on the issue with respect to the pharmaceutical industry in offering his perspective on the importance of including data exclusivity provisions for biologics as found in US law for the Trans-Pacific Partnership (TPP), a regional free trade pact in Asia under negotiation.

Read more »