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Qualification of the Dissolution Apparatus

June
19 /2018
Fee $495.00
Length One Day Course
Category Lecture & Hands On
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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.

Who Should Attend?

Chemists (Research, Quality Control, CRO) involved with dissolution testing and their managers, Regulatory affairs/CMC personnel responsible for documenting compliance with dissolution requirements, Laboratory managers and staff, Analysts, QA/QCU managers and personnel, Training department, Documentation department, and Consultants responsible for assuring dissolution instruments are qualified and suitable for use in a GMP laboratory.

Course Overview

  1. Basis for Qualification
    1. Calibration and qualification of equipment requirements in GMP guidelines for FDA and EMA
    2. USP General Chapter <1058> Analytical Instrument Qualification
    3. USP General Chapter <711> Dissolution refers to Performance Verification Test
  2. Approaches to Dissolution Instrument Qualification
    1. Why is it challenging?
    2. USP Performance Verification Test Tablets allow holistic evaluation of apparatus
    3. FDA Enhanced Mechanical Calibration
  3. Recent Changes
    1. FDA Guidance and FIP Position Paper on Mechanical Qualification
    2. USP changes in acceptance criteria from individuals to mean and RSD
    3. Comparison of Mechanical Requirements: USP vs FDA
  4. Common Pitfalls in Qualifying Dissolution Apparatus
    1. Training
    2. Deaeration
    3. Vessel geometry
    4. Procedure details: filter qualification, dropping tablets, etc
    5. Responding to failures
  5. Recommendations: Plan ahead; train; anticipate failures
    1. Make informed decisions about how instruments will be qualified, and by whom
    2. Training
    3. Document detailed procedures, methods, response to failures
  6. Practical Demonstrations
    1. Mechanical measurements
    2. Performance Verification Tablets
  7. Attendee questions

Learning Objectives

  • 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

Course Accomplishments

Upon completion of this course the learner should:

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

 

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