SOPs for Analytical Method Development V 2.0

This SOP provides a comprehensive approach for validating the Bacterial Endotoxin Test (BET) method using gel clot, kinetic-chromogenic, or kinetic-turbidimetric LAL techniques to detect endotoxins in pharmaceutical products.
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To define a standardized procedure for the successful transfer of sterility testing methodology from the Analytical Method Development (AMD) department to the Quality Control (QC) laboratory for routine execution in compliance with GMP and pharmacopeial standards.
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To define the procedure for the development and validation of analytical methods used to detect and quantify extractables from pharmaceutical packaging components, in compliance with regulatory and pharmacopeial standards.
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This SOP outlines the procedure for developing and validating analytical methods to detect, identify, and quantify leachables that migrate from container closure systems into pharmaceutical products under storage or stress conditions.
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To define the procedure for the development and validation of swab sampling methods for detecting chemical residues or microbial contamination from equipment and surface areas in support of cleaning validation and routine monitoring programs.
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To establish a validated procedure for developing rinse sampling methods that allow detection and quantification of residual active ingredients, cleaning agents, or microbial contaminants from pharmaceutical manufacturing equipment surfaces after cleaning operations.
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To describe a validated procedure for developing Total Organic Carbon (TOC) analytical methods for the detection and quantification of carbon-based residues on pharmaceutical manufacturing equipment surfaces as part of cleaning validation and verification programs.
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To establish a validated procedure for developing High Performance Liquid Chromatography (HPLC) methods for detecting and quantifying residual active pharmaceutical ingredients (APIs) on equipment surfaces post-cleaning as part of the cleaning validation program.
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To define the procedure for developing a visual inspection method to confirm the absence of visible residues on pharmaceutical manufacturing equipment surfaces following cleaning operations, as part of the cleaning validation program.
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To define the procedure for calculating the Maximum Allowable Carryover (MACO) limit for Active Pharmaceutical Ingredients (APIs) or cleaning agents on manufacturing equipment surfaces to ensure patient safety and prevent cross-contamination.
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