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© WHO – PSM Validations –part 5 Workshop on GMP and Quality Assurance of TB products Kuala Lumpur Malaysia, 21 – 25 February 2005 Maija Hietava M.Sci.Pharm Quality Assurance and Safety: Medicines, Medicines Policy and Standards, Health Technology and Pharmaceuticals Cluster Tel: Fax: World Health Organization Supplementary Training Modules on Good Manufacturing Practices
© WHO – PSM Analytical validation Introduction l Why is analytical monitoring necessary? l What is the purpose of analytical validation?
© WHO – PSM Validation Objectives To introduce the concepts of : l Protocol development l Instrument qualification l Analytical procedure l Extent of validation l Method transfer
© WHO – PSM Validation of analytical procedures requires: l Qualified and calibrated instruments l Documented methods l Reliable reference standards l Qualified analysts l Sample integrity Validation
© WHO – PSM Validation protocol for analytical method l Statement of purpose and scope l Responsibilities l Documented test method l List of materials and equipment l Procedure for the experiments for each parameter l Statistical analysis l Acceptance criteria for each performance parameter Validation
© WHO – PSM Qualification of the instrument l Supplier, model and supplier´s manual l Modifications l Installation and operational qualification l Calibration programs l Maintenance schedules Validation
© WHO – PSM Characteristics of analytical procedures (1) l Accuracy l Precision l Repeatability l Reproducibility Validation
© WHO – PSM Validation Relationship between accuracy and precision Accurate AND Precise
© WHO – PSM Characteristics of analytical procedures (2) l Ruggedness l Robustness l Variability caused by: ä Day-to-day variations ä Analyst-to-analyst ä Laboratory-to-laboratory ä Instrument-to-instrument ä Chromatographic column-to-column ä Reagent kit-to-kit ä Instability of analytical reagents Validation
© WHO – PSM Characteristics of analytical procedures (3) l Linearity and range l Specificity l Sensitivity l Limit of detection l Limit of quantitation Validation
© WHO – PSM LOQ, LOD and SNR l Limit of Quantitation l Limit of Detection l Signal to Noise Ratio noise Peak A LOD Peak B LOQ Baseline Validation
© WHO – PSM Different classes of analytical tests l Class A: To establish identity l Class B: To detect and quantitate impurities l Class C: To determine quantitatively the concentration l Class D: To assess the characteristics Validation
© WHO – PSM * A degree of bias may be allowed Characteristic A B quant. B Limit test CD Accuracy X XX* Precision X XX RobustnessXXXXX Linearity and range X XX SpecificityXXXXX Limit of detection X Limit of quantitation X Validation
© WHO – PSM Extent of validation l New methods require complete validation l Pharmacopoeial methods require partial validation (or verification) l Significant changes mean partial revalidation ä equipment changes ä formula changed ä changed suppliers of critical reagents Validation
© WHO – PSM Analytical method transfer l Method transfer protocol and procedure ä precision ä accuracy ä ruggedness l Written and approved specific test method l Proficiency check l Formal acceptance by new laboratory Validation
© WHO – PSM Validation Typical validation of HPCL assay (1) l System suitability (performance check) ä system precision ä column efficiency ä symmetry factor ä capacity factor
© WHO – PSM Validation Typical validation of HPLC assay (2) l Method validation ä specificity ä accuracy ä precision ä linearity ä robustness
© WHO – PSM Biological assays l Can be difficult to "validate" l "Validity" on a case by case basis l Strictly adhere to the Biological Testing monographs in pharmacopoeias Validation
© WHO – PSM Microbiological testing requiring validation l Microbial limit testing l Microbial count l Sterility testing l Preservative effectiveness testing l Environmental monitoring program l Biological testing Validation
© WHO – PSM Sterility testing validation requirements l Media growth promotion, sterility, pH l Product validation l Stasis testing l Environmental monitoring l Negative controls l Challenge organisms Validation
© WHO – PSM Question no 34 l What is the validation parameter showing that results of analysis are almost all in line?? Validation
© WHO – PSM Validations – part 1 Workshop on GMP and Quality Assurance of TB products Kuala Lumpur Malaysia, 21 – 25 February 2005 Maija Hietava M.Sci.Pharm.
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