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Contract Laboratory Services (CLS) > Pharmaceuticals Analysis >> Method Development, Validation & Transfer >>> Method Validation

CLL designs the method–validation protocols depending on the regulatory body to which the submission is to be made, and the nature of the method (Analytical, Bio-analytical, Bio-pharmaceutical, Clinical). However some of the key steps are:

• Accuracy,
• Repeatability,
• Precision,
• Intermediate Precision,
• Reproducibility Precision  (Inter - Analyst/ Instrument/ Laboratories),
• Selectivity,
• Specificity,
• LoD, LoQ,
• Linearity,
• Range,
• Robustness,
• Response Factor
• Stability for all materials (Short-Term - Bench-Top + Auto-sampler, Long-Term, Freeze-Thaw Cycles), Sample Suitability,
• Method Comparability

INSTRUMENTS:     30 HPLCs (Detectors: MS/MS, UV, ECD, FLD, PDA, RI);      AAS, IC, FTIR, UV-VIS  15 GCs ((Detectors: MS, FID, ECD, TID, PID) – Headspace / Purge & Trap

SPECIFICATIONS: ICH, USP, TGA, EMEA, MHRA, USFDA-CDER, CBER, Client Guidelines

For Method Development & Validation Services, please email validations@choksilab.com .