The Ultimate Resource for Pharmaceutical SOPs and Best Practices
To describe the procedure for determining the linearity and range of analytical methods during method validation to confirm that the method can accurately measure analyte concentrations across a defined range in compliance with ICH Q2(R2).
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To define a systematic procedure for evaluating the precision and repeatability of an analytical method during method validation as per ICH Q2(R2) guidelines.
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This SOP describes the procedures for evaluating ruggedness and robustness of analytical methods developed within the Analytical Method Development department to ensure method reliability and performance under variable conditions, in alignment with GMP and ICH Q2(R1) guidelines.
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This SOP outlines the procedure to determine the Limit of Detection (LOD) and Limit of Quantification (LOQ) of analytical methods developed in the Analytical Method Development department. The goal is to ensure methods meet sensitivity and quantification requirements as per ICH Q2(R1).
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This SOP describes the procedure for conducting solution stability studies during analytical method development. The purpose is to evaluate the stability of analytes in sample solutions, diluents, and mobile phases under laboratory conditions and to determine suitable storage durations and conditions, in compliance with GMP and ICH Q2(R1) requirements.
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This SOP outlines the procedure for verifying pharmacopoeial analytical methods (e.g., USP, IP, BP, Ph.Eur.) to confirm their suitability for intended use in the Analytical Method Development (AMD) laboratory, in compliance with ICH Q2(R1), GMP, and WHO TRS 996.
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This SOP defines the standardized procedure for conducting intermediate precision studies for analytical methods developed in the Analytical Method Development department. The objective is to assess the impact of variability in analysts, instruments, and days on method performance, in accordance with ICH Q2(R1).
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This SOP defines the procedure for establishing and validating system suitability criteria for analytical methods used in Analytical Method Development. The criteria ensure that analytical systems are performing consistently to produce reliable and reproducible data before and during analytical runs.
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This SOP describes the procedure for revalidation of analytical methods to ensure their continued suitability for intended use following changes to method parameters, equipment, or manufacturing processes. It ensures that all revalidation activities align with ICH Q2(R1), WHO guidelines, and GMP expectations.
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This SOP outlines the procedure for the formal transfer of validated analytical methods from the Analytical Method Development (AMD) department to the Quality Control (QC) department. The goal is to ensure that the method performs reliably under routine laboratory conditions and complies with GMP and ICH Q14/Q2(R2) guidelines.
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