Streamlining The Regulatory Submission Through The Transition Of Chemistry Manufacturing And Control (Cmc) On Dossier Submission
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Abstract
The Chemistry, Manufacturing, and Controls (CMC) for a medicinal product is a body of knowledge which describes the manufacturing process itself, as well as quality control release testing, requirements, and product stability. The complexity of Chemistry Manufacturing & Control (CMC), a crucial step in the drug development process, rises with time. Manufacturing of the finished drug product and bulk drug material, as well as the establishment of standards, release criteria, stability programmes, and analytical techniques,are all included in CMC. The strategy must take into account important CMC milestones and decision points as well as regulatory CMC objectives, challenges, the present regulatory environment, and any pertinent precedents. Poor planning frequently results in CMC errors, and it can cause significant, highly visible delays in bringing promising medications to market. This information is needed for Module 3 of FDA new drug applications (NDAs) Proposals
Researchers Make an effort to improve the clarity, reliability, and thoroughness of NDA applications. Assuring the quality of the final product at every stage of development is CMC's main goal. However, by concentrating on the right areas, frequently prevent problems from becoming expensive or time consuming delays.
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References
Genpact. CMC regulatory affairs: An introduction to CMC and compliance,
https://www.genpact.com/insight/an-introduction-to-cmc-regulatory-compliance (Accessed 8 January 2016)
Translational Medicine Group. Chemistry Manufacturing & Controls,
https://tmg.mgh.harvard.edu/services/chemistry-manufacturing-controls.
Kim R. Hejnaes, Tom C. Ransohoff. Chemistry, Manufacturing and Control.
https://www.sciencedirect.com/science/article/abs/pii/B9780081006238000505 (accessed 2018).
Element. Understanding Chemistry, Manufacturing and Controls,
https://www.element.com/nucleus/2022/understanding-chemistry-manufacturing-and- controls (Accessed 5February 2022).
Propharma. Chemistry, Manufacturing and Controls Advice and Management,
https://www.propharmagroup.com/regulatory-affairs/chemistry-manufacturing-and-controls- cmc-advice-and- management/
Inpharmatics. Understanding Regulatory Submissions and the role of Regulatory CMC Project Mangement,
https://dsinpharmatics.com/understanding-regulatory-submissions-and-the-role-of-regulatory-cmc-project- management/
Regulatory Focus. CMC Regulatory Strategy, https://www.raps.org/news- and-articles/rf- quarterly/rfqpdfs/2022/q3/22-9_rfq-3_antonelli_article.aspx (Accessed September 2022).
Debbie Jordan. An overview of the Common Technical Document (CTD) regulatory dossier, file:///C:/Users/shaik/Downloads/2047480614z2e000000000207.pdf (Accessed 2014)
U.S Food and Drug Administration. pharmaceutical quality/chemistry, manufacturing & controls(pq/cmc),
https://www.fda.gov/industry/fda-data-standards-advisory-board/pharmaceutical- quality chemistry-manufacturing-controls-pqcmc (Accessed 30 March 2022)
Inpharmatics. Top five cmc clinical holds, https://dsinpharmatics.com/wp- content/uploads/2019/01/top-5-reasons-for-cmc-clinical-holds.pdf
U. S Food and Drug Administration. Study data Technical Rejection Criteria,
https://www.fda.gov/media/160966/download (Accessed 27 April 2022)