Dissolution Instrument Qualification to Meet Requirements and Minimize Product OOS Dissolution Results

This 2-hr Dissolution Instrument Qualification webinar will discuss recent FDA requirements for dissolution instrument qualification and provide practical suggestions to avoid pitfalls in performance of the tests, minimize Performance Verification Test and product failures.

Why Should You Attend:

This interactive course is designed to provide the participant with a knowledge of the requirements for dissolution instrument qualification, an area which has been changing rapidly over the last few years. Both the use of USP Performance Verification Tablets and mechanical approaches will be discussed, as well as the requirements presented in the USP and in a recent FDA Guidance. Pitfalls in the performance of the tests as well as instrument issues which are not addressed by the Qualification procedures will be addressed. Finally, some of the practical suggestions that can minimize both PVT and product failures will be presented. There will be ample opportunity for participant questions.

Learning Objectives:

• Upon completion of this course the learner should
• Identify the approaches to dissolution instrument qualification and the requirements expressed by USP and by FDA.
• Perform the qualification procedures with techniques that will minimize qualification failures.
• Evaluate and document the qualification results, and understand the potential impact of marginal results.
• Understand some of the issues which are not addressed by the current qualification procedures.
• Be aware of some of the practical considerations that can affect routine dissolution testing results, even with well qualified instruments.

Areas Covered in the Seminar:

• Basis for Qualification.
• Calibration and qualification of equipment requirements bin GMP guidelines for FDA and EMA.
• USP General Chapter < 1058> Analytical Instrument Qualification.
• USP General Chapter < 711> Dissolution refers to Performance Verification Test.
• Approaches to Dissolution Instrument Qualification.
• More challenging due to chemical, physical and temporal factors affecting results.
• Mechanical specifications available for vessels, stiffing units and assembled instrument.
• USP Reference Tablets allow holistic evaluation of apparatus.
• Recent Changes.
• FDA Guidance and FIP Position Paper on Mechanical Qualification.
• USP changes in acceptance criteria from individuals to mean and RSD.
• Common Pitfalls.
• Training.
• Desecration.
• Vessel geometry.
• Procedure details: filter qualification, dropping tablets, etc.
• Responding to failures.
• Recommendations.
• Make informed decisions about how instruments will be qualified, and by whom.
• Training.
• Document detailed procedures, methods, response to failures.
• Questions and discussion.

Who Will Benefit:

This webinar will provide valuable assistance to all drug companies/manufacturing sites.Those that would benefit most would be:

Chemists (Research, Quality Control, CRO) involved with residual solvents testing and their managers,

• Regulatory affairs/CMC personnel responsible for documenting compliance with residual solvents requirements
• Laboratory managers and staff
• Analysts
• QA/QCU managers and personnel
• Training department
• Documentation department
• Consultants