Analytical Method Development and Validation
Venue: Window Conference Venue
|Event Date/Time: Dec 07, 2009||End Date/Time: Dec 08, 2009|
Course Dates: 7 & 8 December 2009
Course Venue: Window Conference Venue, London UK
Cost: Â£1160.00 + VAT Â£174.00 (Total Â£1334.00)
Analytical methods must be validated to provide reliable data for regulatory submissions. These methods are essential for a number of purposes, including testing for QC release, testing of stability samples, testing of reference materials and to provide data to support specifications.
This course provides a comprehensive coverage of the method development and validation requirements that are essential to progress a pharmaceutical compound, at each stage of product development.
Upon completion of this course, delegates will have learned what is necessary to develop and validate methods for drug substance and drug product to comply with international regulatory guidelines.
Outline of course
* Requirements for a stability-indicating analytical method
o Anticipation of likely degradation products
+ From experience with compound
+ From forced degradation (stress testing) of drug substance, as per ICH guidance
+ What problems may be anticipated with likely degradation products?
+ Are degradation products likely to be enantiomers or diastereoisomers?
* Analytical method development
o Specificity: peak purity determination (Diode array and MS detectors)
o Reminder of the importance of resolution, separation factor (selectivity), capacity factor and column efficiency).
o Selecting the column for analysis
o Selecting the mobile phase (optimise pH etc)
o Gradient/isocratic operation appropriate?
o Calculation of mass balance and its significance
o Avoiding false identification, particularly in drug product analysis
o Consideration of ICH Q3A/B (identification of deg prods > identification threshold)
o Other attributes to be monitored during the stability study?
* Validation of stability-indicating analytical method
o To ICH Q2(R1)
o Intro/reminder of parameters to be validated
o Extent of validation
o Acceptance criteria
o Validation procedures and protocols
o Dealing with validation failures
* Transfer of stability-indicating analytical method
o In-house or external transfer
o Which parameters should be compared between originator and second lab?
o Comparative testing or re-validation?
o Reference standards and samples
o The process and communication
o Transfer protocols and acceptance criteria
o Typical pitfalls in method transfer
o What if the acceptance criteria are not met?
* Stability study documentation
o Designing the ideal stability study
o The stability protocol
o The stability report
The course will include interactive workshops
Dr Roland Collicott