Dissolution Instrument Qualification

ComplianceOnline, Online Event
2011-04-26

Why Should You Attend: Qualification and calibration of analytical instruments is a key component of CGMPs in each of the major regions. Calibration failures for dissolution instruments have plagued the industry for many years. This is not unexpected, since the dissolution test is more challenging than many other analytical tests, since it involves chemical and physical factors that are changing in a very rapid timeframe. In the last several years there has been a lot of change related to qualification of dissolution instruments.

Compendial chapters on dissolution have been harmonized globally, USP introduced a new format for acceptance criteria for the Performance Verification Test, added a Toolkit to aid executing the PVT, and FDA (and others) have indicated that Enhanced Mechanical Calibration (without the use of calibrator tablets) can be an acceptable approach for qualification of these devices.

This course is designed to provide participants with an understanding of the requirements for dissolution instrument qualification and to provide strategies that will enhance success and minimize resource requirements. The course will address compendial requirements and recent FDA statements about acceptable, alternative approaches.

We will discuss the recent changes regarding the format of the USP specification for the Performance Verification Test and USP and FDA statements regarding Mechanical Calibration. Common pitfalls will be explored, and recommendations made for building a sound dissolution instrument qualification program which may reduce calibration failures as well as questions from regulatory inspectors.

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

 Learning objectives:

• Understand the requirements for dissolution instrument qualification from a compendial and regulatory perspective.
• Understand the recent changes from both USP and FDA.
• Identify common pitfalls related to dissolution instrument qualification.
• Develop a program which will enhance compliance while reducing resource requirements.

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

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