Standard Operating Procedure for Preservative Content Testing in Gels
1) Purpose
The purpose of this SOP is to define procedures for testing preservative content in gels to ensure efficacy and compliance with regulatory requirements.
2) Scope
This SOP applies to the Quality Control (QC) department responsible for performing preservative content testing on gels manufactured at the pharmaceutical manufacturing facility.
3) Responsibilities
Quality Control (QC): Perform preservative content testing according to defined procedures and standards.
Quality Assurance (QA): Oversee the implementation of preservative content testing procedures and ensure compliance with SOPs and regulatory guidelines.
R&D or Formulation Development: Provide formulation details and method validation support for preservative testing.
4) Procedure
4.1 Sample Preparation
4.1.1 Collect representative samples from finished gel batches with documented batch/lot numbers and production records.
4.1.2 Prepare samples according to validated procedures to ensure accuracy of preservative content analysis.
4.2 HPLC Method Setup
4.2.1 Set up the High-Performance Liquid Chromatography (HPLC) equipment with appropriate columns, mobile phases, and detector settings.
4.2.2 Calibrate and validate the HPLC system according to established protocols before analysis.
4.3 Preservative Content Analysis
4.3.1 Inject prepared samples into the HPLC system and run the analysis using validated method parameters.
4.3.2 Quantify preservative content based on peak areas or other validated analytical parameters.
4.4 Method Validation
4.4.1 Validate the HPLC method for preservative content testing to ensure accuracy, precision, and specificity.
4.4.2 Document validation protocols, results, and acceptance criteria for each preservative tested.
4.5 Interpretation of Results
4.5.1 Compare test results against predefined acceptance criteria and specifications.
4.5.2 Record and document preservative content for each tested sample.
4.6 Compliance Assessment
4.6.1 Evaluate preservative content test results for compliance with pharmacopoeial limits or company specifications.
4.6.2 Document compliance or non-compliance with preservative content requirements.
4.7 Reporting and Documentation
4.7.1 Prepare detailed test reports documenting test results, compliance status, and any deviations.
4.7.2 Maintain accurate records of all preservative content testing activities, including protocols, data sheets, and reports.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
HPLC: High-Performance Liquid Chromatography
6) Documents, if any
– Preservative Content Testing Protocols and Procedures
– HPLC Method Validation Reports
– Test Reports and Data Sheets
7) Reference, if any
– Pharmacopoeial monographs (e.g., USP, Ph. Eur.) on preservative testing requirements
– Company-specific formulation and testing standards
8) SOP Version
Version 1.0