Pharmaceutical manufacturing is evolving as the industry adopts the science- and risk-based approach inherent in FDA’s quality-by-design (QbD) initiative. QbD has raised the bar in augmenting process understanding to ensure consistent product quality, and equipment manufacturers, ingredient suppliers, and manufacturers are responding with innovation in their products and services.

Shows such as INTERPHEX 2013 enable attendees to come together to share scientific innovation and discuss the trends and topics affecting the industry. One such topic is the QbD initiative and its impact on the pharmaceutical industry. Pharmaceutical Technology is hosting a panel discussion on implementing QbD during the INTERPHEX sessions, taking place Wednesday, April 24, at 10:15 am. Manufacturing Editor Jennifer Markarian will be moderating a special panel featuring Dr. John Lepore, senior director of Chemical Process Development and Commercialization for Global Pharmaceutical Commercialization at Merck and Co.; Chris Moreton, vice-president pharmaceutical sciences at FinnBrit Consulting; and Jonathon Thompson, technical sales consulting supervisor at Invensys.  The panel will share their insight and practical experience in implementing QbD, including strategies for defining a design space, adaption of manufacturing processes, the feasibility for real-time release testing, and the keys to continuous process verification. The panel will also discuss the benefits and challenges of QbD implementation.

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Pharmaceutical Technology will be moderating a panel discussion, “Lessons Learned: Successes and Challenges in Implementing Quality by Design,” on Wednesday Apr. 24 from 10:15 to 11:15 at INTERPHEX in New York City. You can listen to a podcast about the panel discussion that is posted on PharmTech’s homepage.

Dr. John Lepore, senior director of Chemical Process Development and Commercialization for Global Pharmaceutical Commercialization at Merck and Co., will provide expertise on application of design space and control strategies for API manufacturing. Dr. Chris Moreton, FinnBrit Consulting, will share his expertise in how to incorporate excipients into the design space. Jonathon Thompson, senior manager of Compliance Services Consulting at Invensys Operations Management will use his experience to discuss challenges in adapting the manufacturing process from a control perspective. Together, the panel will consider the benefits of adapting QbD and the challenges yet to be addressed. I hope to see you there.

Representatives from Merck, Pfizer, and Novartis shared their recent efforts in applying quality-by-design (QbD) concepts to analytical methods, and Todd Cecil from USP explained the related new draft USP chapter in a symposium at Pittcon on Monday, March 18, 2013. The session, “Understanding Analytical Method Variance and the Impact for QbD Filing for Pharmaceutical Products,” was sponsored by the American Chemical Society’s Division of Analytical Chemistry (ACS ANYL) and the American Association of Pharmaceutical Scientist’s  Analysis and Pharmaceutical Quality Section (AAPS APQ). Read more »

Are equipment innovations keeping up with manufacturers’ needs? What do industry members think about quality by design and process analytical technology? The editors at Pharmaceutical Technology and Pharmaceutical Technology Europe are currently running a survey of trends in finished drug product manufacturing and innovation in pharmaceutical equipment and manufacturing to gain feedback on these and other questions. Are you involved with machinery and equipment for solid dosage or parenteral products? Click here to take the survey. Read more »

Guest blog written by Nancy Berg, President and CEO, ISPE.

At the inaugural joint FDA/ISPE conference on CGMP earlier this year, the FDA’s Dr. Janet Woodcock delivered a strong message to the pharmaceutical industry: the efforts to adopt Quality by Design (QbD) principles within pharmaceutical manufacturing must be a top priority for the industry. She put the onus on industry and regulators to find ways to work together more effectively, to engage in productive conversations, and to dissolve roadblocks to QbD and the issues that lead to counterfeiting, shortages, and other threats to safe, high-quality medicines. Read more »

Guest blog by Justin O. Neway, PhD., Vice President & Chief Science Officer, Aegis Analytical, jneway@aegiscorp.com

More than a year has passed since the FDA issued its guidance, “Process Validation: General  Principles and Practices,” which describes process validation in three stages – Process Design, Process Qualification and Continued Process Verification. Companies are making progress with how to incorporate these guidelines cost effectively for science-based decision making that improves quality–the consequences of poor quality are too costly. Read more »

The pharmaceutical industry has sometimes been slow to embrace ideas that promise great practical benefits. The industry’s ingrained aversion to risk is partly to blame, but it’s usually not the whole story. Take the quality-by-design (QbD) initiative, which posits that the better a company understands a product’s quality attributes, the more likely that product will be safe and efficacious. The industry has generally supported this initiative, and Pfizer has brought it into the spotlight. Read more »

In my first blog post on the 4th PDA Europe Workshop on Monoclonal Antibodies, I touched upon some of the issues discussed around the QbD paradigm, the assessment of critical quality attributes and what this actually means to industry and regulators alike. There was plenty of discussion and debate, with one or two people questioning whether a QbD approach was even practicable. Read more »

Ok, so there wasn’t really a war on at the 4th PDA Europe Workshop on Monoclonal Antibodies, though there was plenty of mildly heated discussion. I simply could not resist the Lucas reference.

Conducted in Basel (Switzerland) in mid-June, the workshop was fully attended, but relatively small, such that it could “foster a feeling of closeness and networking”, according to Richard Levy, senior vice president, scientific and regulatory affairs at the Parenteral Drug Association (PDA). And indeed it did; the numerous coffee breaks were a great opportunity for industry peers and regulators to mix and continue discussions initiated in presentations. Perhaps any bigger, and the sense of relaxed community would be lost… Read more »

Reading PharmTech’s October article on Critical Challenges to Implementing QbD gave me the impression that we might have the road map to Moksha or Nirvana. Unfortunately that was not meant to be. Somehow there is a belief that PAT in pharmaceutical industry is the roadmap to QBD, pharmaceutical industry salvation. In this article, blame of not achieving “pharmaceutical industry salvation” has been attributed to unfamiliarity with the used equipment and corporate culture. I do not believe either of these is completely true. Read more »