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Subscribe NewsletterFDA Compliant HPLC Qualification and Performance Testing
Product Id
:
600110
Overview: Learn how to select, conduct and document the right tests in the right sequence.
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.
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.
Areas Covered in the Session:
- 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
Who Will Benefit:
- QA managers and personnel
- Analysts and lab managers
- Analysts
- Regulatory affairs
- Training departments
- Documentation department
- Consultans