The Ultimate Resource for Pharmaceutical SOPs and Best Practices
This SOP defines the procedure for determining the end point of wet granulation using Near Infrared Spectroscopy (NIR). The goal is to identify the optimal moisture level and ensure batch-to-batch granule consistency by integrating real-time PAT tools into process control decisions.
Click to read the full article.
This SOP defines the step-by-step procedure for the development, optimization, and validation of a dissolution method intended for pharmaceutical dosage forms comprising coated beads within hard gelatin or HPMC capsules. It ensures reproducible drug release profiling, detection of burst release or incomplete release, and meets regulatory expectations for modified-release formulations.
Click to read the full article.
This SOP outlines the procedure for developing and validating a method to assess the uniformity of mass of solid oral dosage forms such as tablets, hard gelatin capsules, and soft gelatin capsules. This ensures dosage consistency, regulatory compliance, and batch acceptance based on pharmacopeial specifications.
Click to read the full article.
The purpose of this SOP is to define the standardized procedure for preparing a linearity data table as part of analytical method development and validation. It includes steps for sample preparation, data recording, regression analysis, and documentation to demonstrate the method’s ability to produce results that are directly proportional to the concentration of analyte across a specified range.
Click to read the full article.
This SOP defines the procedure for calibration of High-Performance Liquid Chromatography (HPLC) systems to ensure accurate and reliable performance in support of analytical method development and validation activities. Proper calibration maintains data integrity and complies with current Good Manufacturing Practices (cGMP).
Click to read the full article.
This SOP defines the standardized process for qualifying analytical instruments to ensure that they are installed correctly, operate as intended, and consistently perform within established parameters. The procedure aligns with regulatory requirements such as GMP, ICH, and 21 CFR Part 11.
Click to read the full article.
This SOP defines the step-by-step process for verifying analytical procedures prior to their adoption in routine quality control testing. The objective is to confirm that the method is suitable for its intended use under actual laboratory conditions.
Click to read the full article.
The purpose of this SOP is to establish a systematic procedure to identify and assess potential interference from blank solutions and placebo matrices in analytical method development. It ensures that the analytical method is specific and suitable for the intended use without false positives or overlapping peaks.
Click to read the full article.
The purpose of this SOP is to provide detailed instructions for the calibration of UV-Visible spectrophotometers to ensure accurate wavelength, photometric, and stray light performance for reliable analytical testing in method development.
Click to read the full article.
The purpose of this SOP is to outline the qualification process and periodic performance verification procedures for analytical balances to ensure they provide accurate, consistent, and reliable weight measurements as per GMP and ICH guidelines.
Click to read the full article.