Standard Operating Procedure for Assay of Active Ingredient in Gels
1) Purpose
The purpose of this SOP is to establish procedures for the quantitative determination of the active ingredient content in gel products to ensure potency and consistency.
2) Scope
This SOP applies to all personnel involved in the assay of active ingredients in gel products within the pharmaceutical manufacturing facility.
3) Responsibilities
Quality Control (QC) Analyst: Perform assay testing according to this SOP.
Formulation Scientists: Provide input on method development and optimization.
Quality Assurance (QA) Team: Review and approve assay procedures and results.
4) Procedure
4.1 Sample Preparation
4.1.1 Prepare samples according to specified extraction or dilution procedures.
4.1.2 Ensure samples are representative and adequately mixed before testing.
4.2 Assay Method
4.2.1 Use validated analytical methods (e.g., HPLC, UV-Vis spectroscopy) for assay testing.
4.2.2 Perform assays under controlled conditions and according to defined parameters.
4.3 Calibration
4.3.1 Calibrate analytical instruments using certified reference standards.
4.3.2 Verify instrument performance and accuracy before each assay session.
4.4 Data Analysis
4.4.1 Analyze assay results against established acceptance criteria and specifications.
4.4.2 Calculate and report the concentration of the active ingredient in each sample.
4.5 Reporting and Documentation
4.5.1 Document assay testing procedures, results, and calculations.
4.5.2 Maintain complete and traceable records of assay testing for batch records and regulatory compliance.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
HPLC: High-Performance Liquid Chromatography
UV-Vis: Ultraviolet-Visible Spectroscopy
6) Documents, if any
– Assay Testing Records
– Method Validation Reports
– SOP for Instrument Calibration
7) Reference, if any
– USP General Chapter <621> Chromatography
– ICH Q2(R1): Validation of Analytical Procedures
– Company-specific assay testing guidelines
8) SOP Version
Version 1.0