I’m here in Seattle at the USP Science and Standards Symposium, which is focusing on all things biologic and biotech. Representatives from a majority of the pharmacopeia’s expert panels are here, as are a few FDA officials, and industry members from around the world–some 30 countries are represented in fact. Various new approaches by USP are aiming to help industry better understand, develop, test, and manufacture biological products, including biosimilars. Read more »

The European pharma industry has been very quiet in the summer months, but September has seen a flurry of action (and press releases to my inbox) as companies start gearing up for one of the most important European events for the pharma industry: CPhI Worldwide. The show starts on 25 October, and I hope you’ve made your travel arrangements to Frankfurt (Germany) because some flights and hotels are fully booked! This show is one of the most important in many European companies’ calendars.

I’ve been reading a lot about CPhI this week as companies prepare their media campaigns and with the start of October looming, I thought I’d take a brief look at where the behemoth event started and where it’s going. Read more »

Written by Ben Comer for Pharmaceutical Technology

R&D departments and payers need to communicate early in the drug development process: If pharma is a day late, then payers are likely to be a dollar short, according to panelists at the Galien Forum on Tuesday. Read more »

FDA’s Steve Wolfgang led a talk about supply chain concerns and regulatory considerations at today’s PDA-FDA Joint Regulatory Conference in Washington, DC. We all know that the percentage of drugs manufactured abroad is growing as are the number of foreign manufacturing establishments abroad. These changes and globalization in general have led to more complex supply chains and the greater need for scrutiny. Among some newer supply chain challenges industry has to worry about, noted Wolfgang: certificate of analysis laundering, shadow and show factories, dietary supplements spiked with APIs, diversion of legitimate product (e.g., cargo theft), and illegal distribution (e.g., internet sales of drugs). Wolfgang touched on other supply chain challenges as well in today’s session.

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This morning’s session at the PDA-FDA Joint Regulatory Conference in Washington, DC, honed in on common CMO-based questions about regulatory expectations, corporate responsibility, and sub-suppliers. Several audience members wanted to know what the agency has in mind in this area of contract manufacturing. Read more »

Several things are changing in regulatory inspections in the US and industry should be prepared. Zena Kaufman, division vp of global pharmaceutical operations at Abbott, highlighted what’s new in domestic inspections at the PDA-FDA 2011 Joint Regulatory Conference taking place this week in Washington, DC. Read more »

FDA’s Monica Caphart listed the top 10 domestic inspection observations today, in Washington, DC, at the PDA-FDA Joint Regulatory Conference. Number one on the list is the quality control unit, says Caphart, who is director of the Domestic Operations Branch within FDA’s Division Office of Regulatory Affairs. Below are the other top-10 citation areas: Read more »

Written by Karen Ginsbury

With the finalization of FDA’s Guidance [i] in January of this year, the process validation paradigm has undergone an irreversible change. Out with the old “three batches and a prayer and we’re done for the next 25 years” and in with the life-cycle concept of validation management. Read more »

In just a few weeks, the PDA-FDA Joint Regulatory Conference is taking place in Washington, DC. Between 800 and 1000 attendees are expected, including good representation from FDA. I spoke with Susan Schniepp, co-chair of the meeting, vice-president of quality for OSO Biopharmaceuticals, and a member of PharmTech’s Editorial Advisory Board, to see what participants can expect this year. Read more »

The International Conference on Harmonization (ICH) released a summary of its June 2011 meeting of the steering committee and expert working groups. The meeting was held in Cincinnati and chaired by FDA. Below is a recap of the key progress made regarding ICH’s quality and multidisciplinary working groups. Read more »