SOPs for Analytical Method Development V 2.0

The purpose of this SOP is to define the procedures for assessing the morphology of active pharmaceutical ingredients (APIs), excipients, and formulated products using validated microscopic techniques, including optical microscopy and Scanning Electron Microscopy (SEM), in the Analytical Method Development (AMD) laboratory.
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This SOP outlines the procedure for developing and optimizing Microbial Limit Test (MLT) methods to detect and quantify microbial contamination in non-sterile pharmaceutical products, in accordance with pharmacopeial guidelines (USP, IP, EP).
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This SOP defines the optimized procedure for determining the Total Viable Count (TVC) of aerobic microorganisms (bacteria and fungi) present in pharmaceutical products using plate count techniques, supporting regulatory compliance and quality control objectives.
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This SOP describes the procedure for developing a validated sterility test protocol to detect viable contaminating microorganisms in sterile pharmaceutical products using the membrane filtration and direct inoculation methods in accordance with pharmacopeial standards.
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This SOP outlines the procedure for developing a validated method for the Bacterial Endotoxins Test (BET) using the gel-clot, turbidimetric, and chromogenic techniques to detect and quantify endotoxins in parenteral products and water for injection (WFI).
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This SOP outlines the procedure for performing suitability testing (also known as method verification) of microbial limit tests to ensure that the product under evaluation does not inhibit microbial recovery, in accordance with USP and guidelines.
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This SOP outlines the procedure for the development and validation of test methods to detect specified pathogenic microorganisms in non-sterile pharmaceutical products as per regulatory requirements in USP , IP, and EP.
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This SOP defines the procedure for preparation, validation, and usage of environmental monitoring plates (settle plates and contact plates) for microbial monitoring of cleanroom environments and controlled areas in pharmaceutical manufacturing and analytical areas.
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This SOP outlines the procedure for developing a protocol for Growth Promotion Tests (GPT) of microbiological culture media to verify its ability to support the growth of suitable microorganisms, as per pharmacopeial guidelines.
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This SOP defines the method for estimation of microbial bioburden in pharmaceutical water systems, including Purified Water (PW) and Water for Injection (WFI), using membrane filtration and standard plate count techniques in accordance with pharmacopeial guidelines.
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