• DATLA NIKHILA
• AMEENPALLI BHAVANA
• Y Sarah sujitha

CMC is an acronym for chemistry, manufacturing, and controls which are crucial activities when developing new pharmaceutical products. CMC involves defining manufacturing practices and product specifications that must be followed and met in order to ensure product safety and consistency between batches. Chemistry, Manufacturing and Controls (CMC) of a medicinal product is the body of information that defines not only the manufacturing process itself but also the quality control release testing, specifications and stability of the product together with the manufacturing facility and all of its support utilities, including their design, qualification, operation and maintenance. This describes chemistry, manufacturing, and controls (CMC) post approval manufacturing changes that FDA generally considers to have a minimal potential to have an adverse effect on product quality. Under FDA regulations, post approval changes in the product, production process, quality controls, equipment, facilities, or responsible personnel that have a minimal potential to have an adverse effect on product quality must be documented by applicants in an annual report.

Quality assurance, quality control, pharmacovigiliance, Clinical data management.

"CMC-POST APPROVAL MANUFACTURING CHANGES TO BE DOCUMENTED IN ANNUAL REPORTS ", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.11, Issue 6, page no.g240-g302, June-2024, Available :http://www.jetir.org/papers/JETIRTHE2127.pdf

"CMC-POST APPROVAL MANUFACTURING CHANGES TO BE DOCUMENTED IN ANNUAL REPORTS ", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.11, Issue 6, page no. ppg240-g302, June-2024, Available at : http://www.jetir.org/papers/JETIRTHE2127.pdf