I Don’t Mean to Be Critical
The FDA guidance on process validation issued in January 2011 has turned the quality and product development worlds upside down.
Process Validation and the New Compliance Challenge
The issuance of the new FDA Process Validation Guidance in January of this year is a significant event for several reasons.
The Winds of Change: FDA Flexes Its Muscles
To a regulatory and compliance professional, FDA citations are a part of the landscape. Granted, no one welcomes such a situation, but ensuring regulatory compliance is the core of what we do on a daily basis.
The Performance Conundrum
In my last editorial I spoke about the challenges facing the FDA and industry with regard to the effectiveness of the current regulatory structure.
The Devil Is In The Details
Consolidation on a massive scale amongst the elite of the U.S. pharmaceutical industry raises questions about how to remain competitive.
Meeting The Global Compliance Challenge
There can be no doubt that the last decade for the pharmaceutical and biotech industry has been full of extraordinary change.
The China Quality Challenge
After a recent trip to China, I returned more impressed than ever with the rapid level of development within the major markets there.
Facility Design As A Training Platform
It is safe to say the pharmaceutical and biotech market today bears little resemblance to the market of the last twenty years.
Lean Sustainability: Extending the Operational Excellence Paradigm
There can be no mistaking that we are entering a new era in the pharmaceutical and biotech marketplace.
Harmonization Challenges In Designing An Ex-U.S. Manufacturing Facility
The grave quality issues related to the willful adulteration of Heparin by a key API supplier for Baxter, the Melamine adulteration of baby formula for the world market, and the recent drug import restrictions on Ranbaxy in India have raised serious concerns about the viability of China and India to consistently compete in the U.S. and European markets.
Predicting The Future: a Model for Integrating Facility and Strategic Planning
With a typical production and maintenance lifetime measured in decades, the decision to devote capital resources to build a development or manufacturing facility is a significant investment that carries long reaching implications for any business.
Integrating Business Continuity as Part of Strategic Planning
Business Continuity Planning has emerged as a central component to overall corporate well-being that all sectors of business recognize.
The Impact of the FDA’s Adoption of Risk Management on the Design and Qualification of Aseptic Facilities
The FDA is reinventing its approach to quality and compliance and is driving the industry in the direction of a more concrete and cohesive argument for process understanding.