Chemistry, manufacturing and controls; also referred to as pharmaceutical quality/CMC. The physical and chemical characteristics of drug products, ensure the quality from processing and analytical perspectives and consistency during manufacturing. CMC data are an important part of submissions to regulatory authorities.
Chemistry, Manufacturing and Controls (CMC) is an integral part of any pharmaceutical product application to FDA. CMC is critical to attaining a successful registration filing. CMC is applicable to the entire product lifecycle – it starts during the drug candidate selection phase, and continues through post-approval and beyond
}In streamlining efforts, structured electronic submission approach has been employed and FDA has identified and prioritized pharmaceutical quality/chemistry, manufacturing and controls (PQ/CMC) information that is intended to be submitted in the Module 2 & 3 of the Common Technical Document (CTD) as defined by the International Council for Harmonization's (ICH) M4 Common Technical Document (CTD).
}However, currently what is submitted in Module 3 of the (eCTD) is not necessarily comprehensive to cover all eCTD product quality information, only those concepts that were considered agreeable to structuring and would bring value to the quality review process.
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Masihuddin Jaigirdar
Pharmaceutics Expert (FDA & Industry Sector)
MJ Consultant
Silver Spring MD
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.MasihuddinMasihuddinMasihuddinMasihuddin
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