Case Study

A QA/QC laboratory will purchase 15 automated HPLC systems for pharmaceutical operation in a Good Manufacturing Practice (GMP) environment. The High performance liquid chromatography (HPLC) systems with UV/Visible detector will be used for active ingredient and impurity analysis. Now you are quality control (QC) manager in the company and try to propose the suitable qualification for the new HPLC system before routine used. Please complete the following task:

2. Identify the analytical test or documentation required for qualification of HPLC system with UV/Vis detector with a brief standard procedure.

a) Installation qualification (10%) (Hint: Show the installation procedure and document required)

b) Operation qualification (20%) (Hint: List 4 tests required for the OQ with explaining the aim of the tests and brief procedures)

c) Performance qualification (10%) (Hint: List 5 testing parameters for the PQ)