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Planning a Validation Strategy -  end of module assignment part 1 – extra notes:

Part 1 of the Assignment is to review the IBM report of the Metamorphosis of Manufacturing and answer 2-questions:

·         Question 1 – The IBM report was written in 2005, and the ICH Guidelines Q7, Q8, Q9 and Q10 were the major changes to the regulatory framework since then that the IBM report did not anticipate.  Write about how the ICH Guidelines have changed the manufacture of medicines from being “an art to a science” to get the marks for Question 1 (and keep your answer to within 2-3 pages or else you will lose marks).

·         Question 2 – Read the Summary of the report in detail (1-page) about how the metamorphosis of manufacturing was envisaged would happen in the future (after 2005) and then go to section of the FDA website about the ICH guidelines (link below) and read the summaries of the ICH Q7, Q8, Q9, Q10 to write about how it is actually happening today – and compare this to the Summary of the IBM Report. This will get the marks for Question 2 (and keep your answer to within 2-3 pages or else you will lose marks). www.fda.gov/drugs/guidances-drugs/international-council-harmonisation-quality

When writing your answer remember that:

·         Pharmaceutical companies are in the business of “manufacturing safe medicines for the public at an affordable cost not entailing excessive regulatory oversight” (as per the FDA and other regulatory agencies).  This is effectively a common Mission Statement for all the companies working in this sector. 

·         The ICH Guidelines details how the FDA and the other regulatory agencies will interpret this Mission Statement when they come to audit a Pharma company.  Their regulatory audit is a scientific measure (and not just the opinion of the auditor) as to how well the needs of the Patients are met by the decisions that the companies make about how to develop, manufacture and sell their medicines.

·         The IBM Report said in 2005 (which predates the ICH Guidelines) that the Pharma industry needed to take a critical look at the quality and compliance performance of their GMP systems in order to move the industry “from an art to a science”, e.g. if you were explaining to someone who is not familiar with the Pharma manufacturing industry about how they can be confident that medicines they buy are safe to use, you could say that “medicines are manufactured under controlled conditions that are the same every time so that medicines produced will be the same quality every time.  In this way if an FDA audit deems that the medicines have been consistently manufactured in compliance with the GMPs and the portion of medicines tested are determined to be safe, then all of the medicines that have been manufactured are deemed to be safe for sale to the public.