In January 2011 we saw another significant document issued by the FDA to provide updated thinking on Process Validation. The document entitled Process Validation: General Principles & Practices is a further extension of the progressive thinking that’s embodied in the ICH documents, Q8,Q9 & Q10 dealing with Pharmaceutical Development, Quality Risk Management & Pharmaceutical Quality Systems respectively.
In building on those ideas the new guidance is requesting an updated three point process which covers a Process Design phase, followed by Process Qualification & Process Verification phases.
In real terms what this, means is an emphasis on upfront thought about the whole process you’re developing to make your favorite products, focusing on building a robust platform of data upon which to design a sustainable qualification program.
Phase two is an emphasis on a “World Class Approach” to testing and control of all the critical process attributes that allow one to demonstrate control and complete process capability metrics for the manufacturing process one is launching.
This is a comprehensive all –inclusive approach that covers;
• Tests and studies to perform
• Criteria to assess the outcomes
• The timing of the various activities
• The responsibilities of the various parties and departments involved
• The documents needed to support & run the various activities.
Phase three is the continuous verification section/phase where one tests the reliability and sustainability of the qualified process on a continues basis through the collection of real-time process data rather than relying on three PQ runs as the industry performed for over 30 years.
This process has been welcomed by industry because it demonstrates the real capability of an industry manufacturing process, rather than the previous mechanism which pharmaceutical consultants and others have for years been drawing attention towards, and stressing the weaknesses of.
Planning and Risk Assessment is a significant piece of Process Validation today and pharmaceutical consultants experienced in Process and Quality Management System Analysis can help product companies to develop a Lean winning strategy that will meet the demands of the regulatory climate.
Over the coming years it will be interesting to observe how this affects the quality of manufacturing performance and related regulatory compliance for Life science manufacturing processes.