As major blockbuster drugs come off patent, the scramble among generics to capture these new markets is just beginning. We can expect the U.S. market to experience continued change and consolidation with cost cutting remaining at the top of the priority list for big pharma.DOWNLOAD ARTICLE
Poised for a new year of challenges and opportunities, we ask what distinguishes 2012 from its preceding year? The word that comes to mind is clarity. Not in the sense of stock market predictability, nor the emergence of clear industry direction, but the clarity that comes from a better understanding of the relationship between government regulation, market demand and industry thinking.DOWNLOAD ARTICLE
It has been nearly eight years since ICH first rolled out its concept paper on Pharmaceutical Development defining the framework for Quality by Design (QbD) and nearly seven since the FDA first embraced the concept in its 2004 guidance on Risk based cGMPs.DOWNLOAD ARTICLE
The FDA guidance on process validation issued in January 2011 has turned the quality and product development worlds upside down. As the industry attempts to translate the principles of the guidance to action a great debate is taking shape surrounding the identification and definition of critical process parameters.DOWNLOAD ARTICLE
The challenge all quality professionals face is answering the question, “How much is enough?” Historically we have had the benefit of very prescriptive FDA guidances or industry best practice to fall back on for our validation programs. Today however, we find ourselves in a brave new world where we are the architects of our own reality and potentially our own demise.DOWNLOAD ARTICLE
The issuance of the new FDA Process Validation Guidance in January of this year is a significant event for several reasons. Fundamentally, the definition of what constitutes acceptable process validation differs dramatically from the conventional definition first put forth in the 1987 guidance.DOWNLOAD ARTICLE
In January 2011, the FDA issued its newest guidance for Process Validation for industry and it is quite a departure from the previous guidance released in 1987. The old approach of developing products and hoping that testing would provide enough information to
predict and control the process is no longer the order of the day.
In January 2011, the FDA issued its new guidance regarding Process Validation. Based upon experience
gathered by the agency since 1987, the new guidance reflects the principles of the 2004 FDA initiative,
Pharmaceutical cGMPs for the 21st Century – A Risk-Based Approach.
Most organizations within our industry have resigned themselves to the concept that operational excellence must be part of any strategic plan to remain competitive.DOWNLOAD ARTICLE