FDA Compliant HPLC Qualification and Performance Testing

High Performance Liquid Chromatography is the most frequently used analytical tool for pharmaceutical and API testing laboratories. FDA and international agencies require HPLC equipment to be calibrated, qualified and tested to ensure accurate and reliable analytical results. Even though this is well known since long time, laboratories are unsure on what exactly should be tested initially and on an on-going basis.

The main challenge is to do the right testing in the right sequence. Attendees will learn how to develop qualification and test protocols from planning and setting specifications through installation, operational qualification to performance testing and reporting. .

For Easy Implementation, Attendees Will Receive:

• SOP: Qualification of High Performance Liquid Chromatographs
• SOP: Testing of High Performance Liquid Chromatographs
  

• FDA and equivalent international requirements
• Examples for recent 483s and Warning Letters
• HPLC qualification according to USP <1058>
• Calibration/qualification phases: design qualification, installation qualification, operational qualification, performance qualification
• Selecting parameters and acceptance limits for HPLC initial and on-going testing
• Recommended test sequence for highest efficiency
• Approach for existing systems
• Approach for automated systems (incl. firmware/computer systems)
• Requalification after equipment changes (move, repair, firmware upgrade, hardware upgrade)
• Documentation requirements.
  

• Laboratory managers and staff
• Analysts in quality control laboratories
• QA managers and personnel
• Regulatory affairs
• Training departments
• Documentation department