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 »

“If QbD is the ocean of knowledge, then generics are just pulling out of the driveway. We haven’t even seen the beach yet,” said Aloka Srinivasan, PhD, a team leader at the FDA Office of Generics (OGD) and a speaker at today’s keynote session of the 3rd Annual Pharmaceutical Technology Conference in Philadelphia, PA. Read more »

We’ve all heard that quality by design and science/risk-based approaches to pharmaceutical manufacturing require a paradigm shift among industry. Well, that message was reinforced again today at the 3rd Annual Pharmaceutical Technology Conference in Philadelphia, PA. Read more »

I’m here at the 3rd Annual Pharmaceutical Technology Conference in Philadelphia, PA. Hot on the agenda is quality. Quality by design, quality via process validation, quality via life cycle production. Nick Cappuccino presented the first session of the morning on ICH Q8, 9, and 10 implementation. Dr. Cappuccino is a member of the ICH Quality Implementation Group. Read more »

Innovation, innovation, innovation .. and a call to focus on science and quality-by-design (QbD) principles. Such was much of the talk yesterday at this year’s AAPS National Biotechnology Conference in Seattle. Speakers discussed the tools the biotechnology industry will need for future innovation and how the industry must center on QbD principles, using lessons learned from small-molecule development and even nonregulated industries. Read more »

Relationship building and the benefit of deepening collaborative business models between excipient manufacturers and pharmaceutical companies in support of formulation development and manufacturing in a quality-by-design (QbD) paradigm and enhancing supply-chain practices was a key takeaway from ExcipientFest Americas, which was held in San Juan, Puerto Rico, this week. ExcipientFest Americas is operated by the Drug, Chemical and Associated Technologies Association (DCAT). ExcipientFest Americas is an exhibition and educational program that addresses technical considerations in excipient selection and formulation development as well as sourcing and supply-chain issues for excipients. Read more »

I participated in an ISPE webinar yesterday with FDA’s Grace McNally regarding the agency’s recently released draft guidance, Process Validation: General Principles and Practices. The guidance is meant to serve as a revision to the 1987 Guideline on General Principles of Process Validation. Read more »

At this year’s AAPS Annual Meeting and Exposition, Pharmaceutical Technology editors conducted video interviews with industry leaders recorded live at PharmTech’s booth on the exhibit floor. Click on the titles below to watch the vidcasts.

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Pharmaceutical Technology took a step into the future with our first Vidcast series from the annual meeting and exposition of the American Association of Pharmaceutical Scientists (AAPS) in Atlanta this week. In doing so, I had the opportunity to discuss the future of drug delivery and formulation with leading experts. Read more »

Yesterday I completed my first vidcast at the AAPS Annual Meeting in Atlanta, Georgia. I had the pleasure of discussing quality by design (QbD) as it applies to analytical methods with one of the top experts in this area: Dr. Moheb Nasr, director of FDA’s Office of New Drug Quality Assessment. Read more »