Quality Assurance & cGMP

This section deals with the systems that ensure products are consistently produced and controlled to quality standards.

• QA vs. QC vs. cGMP: Interns must distinguish between Quality Control (testing the product), Quality Assurance (managing the process), and cGMP (the legal standard for manufacturing).

• Qualification & Validation: This involves proving that equipment works correctly (Qualification) and that processes reliably produce the intended result (Validation). It includes specific concepts like Equipment, Operational, and Process Qualification.

• Calibration: Ensuring that measuring instruments (like scales and pH meters) are accurate and precise.