SOPs for Analytical Method Development V 2.0

This SOP outlines a standardized procedure for evaluating recovery rates of analytes and microorganisms during method development in analytical laboratories. It ensures that the test method accurately detects or quantifies the expected component without loss or interference.
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This SOP outlines the procedure for optimizing membrane filtration techniques used for microbiological and chemical analysis in pharmaceutical products, ensuring filtration efficiency, analyte recovery, and regulatory compliance.
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This SOP describes a validated procedure for testing the effectiveness of disinfectants used in pharmaceutical cleanrooms and laboratory environments against standard microbial strains on various surfaces and conditions, as per GMP and USP guidelines.
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This SOP outlines the methodology for developing and validating an Antimicrobial Effectiveness Testing (AET) method to evaluate the efficacy of antimicrobial preservatives in pharmaceutical products according to USP , EP, and JP guidelines.
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This SOP outlines the procedure for handling samples intended for microbiological testing in analytical method development, ensuring aseptic technique, chain of custody, appropriate storage, and compliance with GMP and GLP practices.
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This SOP outlines aseptic techniques to be followed during sample handling, testing, and media preparation within the Analytical Method Development (AMD) laboratory, to prevent contamination and maintain data integrity during microbiological analysis.
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To outline a standardized procedure for the identification and characterization of impurities in active pharmaceutical ingredients (API) using validated analytical techniques, ensuring compliance with ICH and regulatory expectations.
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This SOP outlines the methodology for identifying and characterizing process related impurities that arise during API synthesis, ensuring regulatory compliance, quality control, and safety through robust analytical practices.
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This SOP outlines the procedures for the isolation and detailed structural characterization of unknown impurities detected in APIs and finished pharmaceutical products, supporting impurity profiling, specification setting, and regulatory compliance.
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This SOP defines the process for applying Liquid Chromatography-Mass Spectrometry (LC-MS) to identify unknown degradation products in pharmaceutical substances and formulations, particularly during forced degradation and stability studies.
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