UNIT 6 : Pharmaceutical Quality, CMC Controls, and Stability Studies
This unit explains pharmaceutical quality concepts with emphasis on Chemistry, Manufacturing, and Controls (CMC) and stability requirements. It covers GMP principles, manufacturing controls, specifications, and ICH stability expectations.
Definition
Pharmaceutical quality is the assurance that a medicinal product is consistently produced and controlled to meet predefined specifications for safety, efficacy, and performance.
Regulatory authorities view pharmaceutical quality as a lifecycle responsibility rather than a one-time approval requirement. Quality data must demonstrate that the product remains consistent from development through commercial manufacturing and throughout its shelf life.
Key Points
Quality is built into the product, not tested into it
CMC data is central to regulatory approval
Quality failures directly impact patient safety
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