The Ultimate Resource for Pharmaceutical SOPs and Best Practices
This Standard Operating Procedure (SOP) outlines the processes for the qualification, approval, handling, labeling, documentation, and storage of primary Reference Standards (RS) and Working Standards (WS) in the Analytical Method Development (AMD) laboratory.
Click to read the full article.
The purpose of this SOP is to define the procedures for ensuring proper documentation, review, storage, and audit trail management of chromatographic data generated from analytical instruments such as HPLC, UPLC, and GC systems used in Analytical Method Development (AMD). The procedure emphasizes adherence to ALCOA+ principles to maintain data integrity.
Click to read the full article.
The purpose of this SOP is to define the standardized approach for conducting filter compatibility studies during analytical method development. This ensures that selected filters do not adsorb or retain active pharmaceutical ingredients (API) or excipients, thus preserving the integrity of the analytical results.
Click to read the full article.
This Standard Operating Procedure (SOP) outlines a validated method for preparing calibration curves using external standards for quantitative analytical method development and validation. Calibration curves are essential for determining the concentration of unknown samples by correlating peak response with known concentrations of standard solutions.
Click to read the full article.
The purpose of this SOP is to define the procedure for conducting accuracy studies during analytical method validation. Accuracy is a critical validation parameter used to determine how close the test results are to the true values by spiking known quantities of the analyte into the matrix.
Click to read the full article.
This SOP defines the methodology for conducting precision studies during the validation of analytical methods. It focuses on repeatability and intermediate precision to assess the closeness of agreement between independent test results under prescribed conditions.
Click to read the full article.
The purpose of this SOP is to provide a structured procedure for establishing, evaluating, and documenting system suitability criteria in analytical methods developed for qualitative and quantitative analysis of pharmaceutical substances and products.
Click to read the full article.
To define a systematic approach for selecting suitable analytical techniques for quantitative and qualitative method development of drug substances and products. The selection ensures compliance with regulatory standards and suitability for intended application.
Click to read the full article.
To establish a comprehensive and systematic approach for optimizing chromatographic parameters during the development of analytical methods, specifically HPLC and GC, ensuring precise, accurate, and reproducible results.
Click to read the full article.
To define a standardized procedure for conducting linearity and range evaluation during analytical method development. This ensures the method can accurately and precisely measure the analyte response over a specified concentration range, in accordance with ICH Q2(R1) guidelines.
Click to read the full article.