Author Archive

Inspections on the Rise. Get Prepared.

Just about a year ago, in July 2011, FDA published a roadmap for addressing the challenges of globalization. The roadmap, “Pathway to Global Product Safety and Quality,” was based on four core building blocks: with a global coalition of regulators, build and strengthen the product safety net around the world; develop a global data-information system; expand intelligence gathering and use, focused on risk analytics and modernized IT; leverage and prioritize resources based on risk. Read more »

Atypical Visible Particles: Can Users and Makers Find Common Ground?

Angie DrakulichIn April 2012, industry experts discussed the issue of atypical visible particles in pharmaceutical raw materials, including excipients, at the joint International Pharmaceutical Excipient Council’s (IPEC) Regulatory Conference and ExcipientFest-Americas Conference in San Juan, Puerto Rico. This topic is key because a primary cause of drug recalls during the past year has been the presence of visible particles, that is off-colored particles or black or tan specs, in pharmaceutical products. The presence of visible particles affects both excipients manufacturers and users with regard to standard expectations for mitigating the atypical visible particles and with regard to decision-making about raw material acceptance criteria. Read more »

Received a 483? The Clock is Ticking.

If your company has ever received a 483 from FDA, you likely had a ton of questions about how to respond, how to make things right, and fast.  With new agency enforcement policies in action since 2009, companies are expected to respond to 483s within 15 business days.  What’s the best format for reporting back to FDA? How will a company know if its response is thorough enough? David Elder, who works in strategic compliance consulting at PAREXEL International, answers these questions in a recent issue of Pharmaceutical Technology. Elder is a former senior official with FDA.

“It has always been in a company’s interest to respond in writing to an FDA–483, List of Inspectional Observations, issued at the conclusion of their inspection. In so doing, the inspected company demonstrates to FDA that it understands the inspectional observations and that it is committed to implementation of corrective and preventive action. A thoughtful, complete, and timely response establishes credibility with FDA.” Read the rest of his response here.

PharmTech Biomanufacturing Partnerships Conference: Key Outsourcing Thoughts

Angie DrakulichThis week, industry members and experts gathered in Philadelphia for two days of informal presentations and discussion regarding biopharmaceutical manufacturing partnerships. The event, hosted by PharmTech and CBI, addressed many common challenges facing the outsourcing sector while also offering potential solutions. Below are a few soundbites from the second day’s discussions (see here for the first day summary). Read more »

Biopharma Manufacturing Partnerships

Angie DrakulichTomorrow opens the Biopharmaceutical Manufacturing Partnerships conference in Philadelphia, in coordination with CBI and Pharmaceutical Technology magazine. Experts are expected to speak on number of key outsourcing issues including effective due diligence, good procurement practices, QbD implementation, tech transfer strategies, and emerging business models.

I’ll be there as will be Patricia Van Arnum, our executive editor. Hope to see you there, and if you can’t make it, stay tuned for reports from the live show.

USP Highlights Excipient Performance

Angie DrakulichIt’s no secret that excipients are not manufactured specifically for pharmaceutical use. In fact, pharma appears pretty low on many excipient makers’ lists of clients. But their importance in drug formulation and in ensuring final product quality has been gaining recognition over the past few years, unfortunately due to some specific events of contamination and adulteration. Because of growing concern in how excipients function and perform, the US Pharmacopeia has developed a new general information chapter on this topic, chapter <1059>. Read more »

The Potential of Big Data

Angie DrakulichIt’s been a few months since the Obama administration launched the Big Data Research and Development Initiative, aimed at pooling large collections of data to gain knowledge and insight into everything from national security to the environment to biomedical research.

Various divisions of the US Department of Health and Human Services are involved in the project, including the National Science Foundation and the National Institutes of Health (NIH), both of which are seeking ways to manage and analyze data collections. As a kickoff to the initiative, NIH placed the human genome project data set into the Amazon cloud for free. Read more »

Healthcare Reform and Next Battles for Industry

This guest blog was written by Christie Bloomquist is a partner in health practice at Hogan Lovells, a global legal practice firm based in Washington DC.

I’ll admit it, I had trouble sleeping this week, knowing that we’d finally know what the Supreme Court thought about the Constitutionality of key Affordable Care Act (ACA) provisions.  Mostly, I wondered if the law that I had spent the last few years of my life working on during its debate in Congress and throughout implementation would be the same at the end of the day as it was at the beginning and what this would mean for the pharmaceutical industry.  Call me nerdy, but I suspect that I wasn’t alone in my tossing and turning all week.

And now that the speculation is over, what’s clear is that the Supreme Court’s decision means status quo for the industry.  Pharmaceutical manufacturers will continue to do what they’ve been doing for over 2 years – implementing ACA.  They’ll continue to process discounts in the Part D coverage gap, they’ll continue to work through the expansion of the Medicaid drug rebate program, they’ll continue to pay the industry excise fee, they’ll continue to think ahead to the implementation of a pathway for biosimilars – and, most importantly, they’ll continue to do all of these things while pursuing innovation of life-improving medicines. Read more »

LIVE from BIO 2012: Capital and Tax Policies Burden Biotech, but Optimism Remains

Angie DrakulichHere in Boston, the crowds are bustling at the BIO 2012 Convention and Exhibition. Today, BIO unveiled survey results that polled about 170 biotech industry leaders and 800 US voters, conducted by Hart Research and Public Opinion Strategies. Approximately 63% of biotech industry leaders said that they feel “very optimistic” about the future of biotech and its ability to develop new products that will meet global needs. A similar survey was conducted in 2007 showing that 79% of industry leaders were optimistic about biotech’s future. So there is a dip in optimism here, but considering the economic downturn of the past couple of years, such a change is not surprising. Read more »

USP Heavy Metal Chapter Revisions on the Way; New Screening Methods to be Implemented

Angie DrakulichThe revised US Pharmacopeia revised chapters on elemental impurity limits and procedures (<232> and <233>) are set to become official by the end of the year, and companies are beginning to think about implementation, which will be required by May 2014 (see back story).

According to the latest update from the USP website, the new chapters will be published in the Second Supplement to USP 35–NF 30 (official Dec. 1, 2012). Conformance with these chapters will be required by May 1, 2014. In the interim, all references to USP General Chapter <231> Heavy Metals will be removed from monographs in the compendia.

The International Conference on Harmonization (ICH) Working Group on Elemental Impurities is simultaneously working to develop a harmonized approach for controlling these impurities, including risk-assessment recommendations and safety limits for specific metals, that meet testing and regulatory filing requirements at the global level. USP has noted that its expert panel is not waiting for the final recommendations from the ICH Q3D Expert Working Group but does note that the limits in the new General Chapter <232>, except for mercury, are in line with those in the stage 2 draft of the Q3D guideline. “At a future date, the Expert Panel intends to revisit General Chapter <232> relative to the Step 4 outcome of ICH Q3D deliberations,” says the USP elemental impurities webpage.

PharmTech is hosting and moderating a free educational webinar about the revised USP chapters on June 14, 2012, with a specific focus on new testing procedures and practices for detecting elemental impurities. Instrumentation, key challenges, best practices, and will be addressed.

Register for the free webinar

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