The Ultimate Resource for Pharmaceutical SOPs and Best Practices
This SOP describes the procedure for conducting solution stability studies to ensure that analytical solutions used during analysis maintain their stability and reliability over specified time intervals. These studies are essential to confirm the accuracy and consistency of assay and impurity testing in drug development and quality control environments.
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This SOP describes the method for calculating the signal-to-noise ratio (S/N) to evaluate the sensitivity of chromatographic methods. The S/N ratio is critical in defining the limit of detection (LOD) and limit of quantification (LOQ) during method validation in the analytical method development process.
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This SOP provides a standardized approach to estimating the detection limit (LOD) of an analytical method using the statistical method based on the standard deviation (SD) of the response and the slope of the calibration curve. This ensures a scientifically sound and reproducible way to determine method sensitivity.
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This SOP defines the procedure for the qualification, documentation, preparation, and utilization of Certified Reference Standards (CRS) within the Analytical Method Development (AMD) department. Proper use of CRS ensures accuracy, traceability, and regulatory compliance of analytical test results.
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This Standard Operating Procedure (SOP) outlines the detailed process for the development of stability-indicating methods (SIMs) used to detect and quantify the active pharmaceutical ingredient (API) and its degradation products in drug substances and products. The aim is to ensure method specificity, precision, and robustness in line with ICH Q1A and Q2(R1) guidelines.
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This SOP outlines the procedure for establishing and evaluating system suitability criteria for analytical methods developed and validated by the Analytical Method Development (AMD) department. System suitability ensures that analytical systems are performing optimally and that results are reliable and reproducible.
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The purpose of this SOP is to establish a standardized approach for documentation during the development of analytical methods to ensure Good Documentation Practices (GDP), traceability, reproducibility, and compliance with cGMP and regulatory expectations.
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This SOP describes the procedure for performing forced degradation studies (also known as stress testing) during analytical method development. These studies help establish the stability-indicating capability of a method by demonstrating that degradation products can be separated and quantified from the active pharmaceutical ingredient (API).
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This SOP provides a detailed procedure for qualification of analytical instruments used in method development, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). The objective is to ensure that instruments are properly installed, function as intended, and perform reliably over time under actual usage conditions.
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To define a standardized procedure for the procurement, qualification, handling, storage, and use of Certified Reference Standards (CRS) in the Analytical Method Development department to ensure data accuracy, reliability, and regulatory compliance.
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