The question is that
You are a member of the Quality Assurance/Validation Team in a Pharmaceutical company that has been manufacturing a wide range of products for the European and US Markets for the last 15 years.
The Quality Department is recently reviewing the approach taken by the company to Process Validation. As a member of the QA/Validation team you have been asked to carry out research on “Continuous Process Verification as an alternative approach to Process Validation”. To this end you are required to carry out a detailed review of the above topic with particular focus on the company.
You will then be required to submit a 1000-1500 word paper on the topic, outlining the implications for companies and making recommendations on the possible integration into company procedure. It is planned long-term to use the paper in the training of new employees who will work on Process Validation in the company.
You should spend some time researching the assignment using the following:
-Relevant Regulatory and Guidance Documents including EMA Draft Guideline on Process Validation 2012, FDA Process Validation Guidance 2011, ICH Q8 Pharmaceutical Development and FDA Guidance on PAT 2004 (references detailed in lecture 6)
-Internet
-library
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