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CMC Documentation

Meaning

CMC Documentation, standing for Chemistry, Manufacturing, and Controls, constitutes the comprehensive body of scientific data submitted to regulatory agencies detailing every aspect of a therapeutic agent’s production, from raw material sourcing to final product testing. For peptide therapeutics in hormonal wellness, this documentation must prove the identity, purity, potency, and stability of the active pharmaceutical ingredient consistently across all manufactured batches. Rigorous CMC adherence ensures that the patient receives a product of unwavering quality and predictable biological effect. This forms the evidentiary backbone of regulatory approval.