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ICH Proposes Harmonization of Drug Substance Manufacturing Processes

This article was originally published in The Gold Sheet

Executive Summary

On April 11, 2008, ICH proposed in a Q11 concept paper that the manufacturing process for drug substances be harmonized. ICH notes that "because of a lack of guidance in the area of drug substance development and manufacturing manufacturers, no general developed harmonized approaches to demonstrating process understanding, particularly regarding sources of variability in product quality, are currently available. Additionally, region-specific requirements are conveyed to the applicants by the authorities on a case-by-case basis. In general, there is currently little consensus or agreement across the industry and the regulatory bodies with respect to manufacturing process information and justification that should be included in the dossier." During discussions at the ICH-Q Drug Substance Roundtable meeting held in Washington in September 2007, participants agreed that many of the principles and concepts that have been addressed in ICH guidelines Q8, Q9 and Q10 are also applicable to the development and manufacture of drug substances. Some examples of technical elements that were recognized as having a "strong need for harmonization" include the selection of materials and components for drug substance manufacture; identification and justification of key manufacturing steps; process controls; process parameters; choice of analytical procedures and acceptance criteria as elements of a total control strategy designed to ensure product quality and consistency; the capacity of processes to reduce or remove impurities and product-related substances; and the evaluation of process robustness. The first meeting of the expert working group is expected to be held later this month. The document is currently in Step 1, which is the consensus-building stage. It is anticipated that the paper will be approved as a Step 2 document in the fourth quarter of 2009 and will receive a step 4 signoff in the fourth quarter of 2010

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