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
As we emerge into the New Year, it is as good a time as any to take stock of where we are as an industry and what we might expect in the months to come. There can be no doubt that 2010 was a watershed year.DOWNLOAD ARTICLE
In my last editorial I spoke about the challenges facing the FDA and industry with regard to the effectiveness of the current regulatory structure. If we were to take a step back and look at our performance as an industry along with the effectiveness of the FDA’s
regulations, I think we definitely have some work to do.
R&D must harness its inherent scientific horsepower and apply it through statistically unbiased experimental designs.DOWNLOAD ARTICLE