Validation of analytical methods, regulatory and practical aspects !! FULL!!

02.06.21 AM; 04.06.21 AM + PM; 08.06.21PM; 11.06.21 AM + PM; 15.06.21 self working; 18.06.21 AM + PM

Prof. Serge Rudaz, UNIGE

Dr Julien Boccard, UNIGE

Prof. Serge Rudaz, UNIGE

Dr Julien Boccard, UNIGE

Dr Jean-Marc Roussel, Independant Consultant, Analytical Methods Development and Validation

The demonstration of the ability of an analytical method to quantify is of great importance to ensure quality, safety and efficacy of pharmaceuticals. Consequently, before an analytical method can be implemented for routine use, it must first be validated to demonstrate that it is suitable for its intended purpose.

The analyst refers to guidelines and regulatory documents, and therefore the validity of the analytical methods is dependent on the guidance, terminology and methodology, proposed in these documents. It is therefore of prime importance to have clear definitions of the different validation criteria used to assess this validity.

The harmonization of validation of analytical procedures was developed by numerous members of the scientific community to understand the objectives of a procedure and to propose protocols that will include these criteria and these objectives. The need to validate methods is obvious and the procedures for performing a rigorous validation program are now relatively well defined. Guides of validation (e.g. SFSTP) were elaborated to help the pharmaceutical industry as well as the various scientist involved in the domain to validate their analytical procedures (for bulk drug and pharmaceutical specialties) and biopharmaceutical procedures (procedures implied in pharmacokinetics studies and of bioequivalence), respectively. Because statistical evaluation of validation results and validation reporting is a major challenge for every analyst, a new statistical and experimental approach based on the accuracy profile was elaborated and evaluated on different types of applications.

This series of lectures and practices will help you to understand the actual definitions in method validation and to show you the latest statistical tools which can help you producing more reliable results faster and in a consistent manner. A comparative commentary of official documents regulating validation of analytical methods (ICH, FDA, EMEA, ISO, etc.) and the understanding in statistical requirements will help to consider some validations protocols and examples. Finally, insights estimating the measurement uncertainty will be given. Thus, even this aspect is not a direct part of method validation, a judicious use of the validation data may help to estimate the uncertainty that should associated with routine results. The latter is of utmost importance for all laboratories that need to provide quantitative results, in order to guarantee their quality and their compliance with the imposed specifications.

02.06.21 AM (JMR) 3hours of teaching:

1. Objective of the Validation (1 hour)

2. Documentation and regulatory bodies (1 hour)

3. Quality Assurance and Traceability (1 hour)

04.06.21 AM (SR) 3 hours of teaching:

4A. Selectivity and Robustness / 4B. Range (1 hour)

4C. Quantitative aspects (2 hours)

1hour reading : ICH - FDA Drugs

04.06.21 PM (JB): 3 hours of STAT

5. Variance and Anova (2 hours of practice)

6A. Formulation pharmaceutique : exemple1 - Part 1 ANOVA (1 hour of practice)

08.06.21 PM (SR) 3 hours of STAT

7. Profils d'exactitude Cours théorique (2 hours of teaching/practice)

6B. Formulation pharmaceutique : exemple (Suite) (1 hour of practice)

11.06.21 AM (SR/JB) 3 hours of teaching and STAT

8. FDA / EMA Biological Fluids (2 hours of teaching)

10A. The Methadone example Part 1 (1 hours of practice)

11.06.21 PM: 2 hours

10B. Alternative Calibration (2 hours)

1 hour of reading : FDA /EMA/ICH10

15.06.21 2 hours of Self Working (STAT)

12. The caffeine/Theophiline/theobromine example

Validation practice STAT incl Correction

1 hour of reading: Uncertainty

18.06.21 AM (JMR) 3 hours of teaching:

Generality of Uncertainty (1 hour)

Method uncertainty (From Validation or others) (1 hour)

Decision with Method uncertainty (1 hour)

18.06.21 PM (SR/JB): 3 hours (STAT)

12. The caffeine/Theophiline/theobromine example (2 hours of practice)

Discussion and Conclusion (1 hour)

Université de Genève, CMU, room TBD

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