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

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

Instructor Profile:

Greg Martin, is President of Complectors Consulting which provides consulting and training in the area of Pharmaceutical Analytical Chemistry.  He has particular interest in QbD/Lean approaches to dissolution testing, impurity methods, method lifecycle (development/validation/transfer) and instrument qualification, and is passionate about using good science and sound logic to achieve high quality results, consistent with cGMPs, while minimizing resources.  Mr. Martin has over 25 years experience in the pharmaceutical industry and was Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company for a number of years.  In addition, he has volunteered for the USP for over 10 years, and currently serves as Vice Chair of the General Chapters – Physical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Weights and Balances and Use of Enzymes for Dissolution Testing of Gelatin Capsules.  He is also Chair-elect of the AAPS In Vitro Release and Dissolution Testing Focus Group.  He serves on the Editorial Advisory Board of the Journal of Validation Technology and Journal of GXP Compliance.

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