Standard Operating Procedure for Quality Control Testing of Gels
1) Purpose
The purpose of this SOP is to define the procedures for performing quality control (QC) testing of gels to ensure they meet the required standards for safety, efficacy, and quality.
2) Scope
This SOP applies to all QC personnel involved in the testing of gels manufactured in the pharmaceutical production facility.
3) Responsibilities
Quality Control Manager: Oversee the QC testing process and ensure compliance with this SOP.
QC Analysts: Conduct the QC tests as per the procedures outlined in this SOP.
Production Staff: Provide necessary samples and support to the QC department for testing.
4) Procedure
4.1 Sample Collection
4.1.1 Collect gel samples from different batches as per the sampling plan.
4.1.2 Ensure samples are labeled correctly with batch number, date, and other relevant details.
4.2 Physical Testing
4.2.1 Appearance: Examine the gel for color, consistency, and homogeneity.
4.2.2 pH: Measure the pH of the gel using a calibrated pH meter.
4.2.3 Viscosity: Measure the viscosity using a viscometer as per the standard method.
4.3 Chemical Testing
4.3.1 Assay of Active Ingredient: Determine the concentration of the active ingredient using validated analytical methods (e.g., HPLC).
4.3.2 Preservative Content: Quantify the preservative content as per the specified method.
4.4 Microbial Testing
4.4.1 Total Aerobic Microbial Count (TAMC): Perform microbial testing to determine TAMC.
4.4.2 Total Yeast and Mold Count (TYMC): Conduct tests to determine TYMC.
4.4.3 Pathogen Testing: Test for specific pathogens such as E. coli, S. aureus, and P. aeruginosa.
4.5 Stability Testing
4.5.1 Conduct stability testing under specified conditions (e.g., temperature, humidity) to assess the gel’s shelf-life.
4.5.2 Record and analyze stability data at predefined intervals.
4.6 Documentation and Reporting
4.6.1 Document all test results in the QC test report format.
4.6.2 Review and verify the test data for accuracy and completeness.
4.6.3 Submit the QC test report to the Quality Control Manager for final approval.
4.7 Handling of Out-of-Specification (OOS) Results
4.7.1 If any test results are out of specification, follow the OOS SOP to investigate the cause.
4.7.2 Document the investigation findings and any corrective actions taken.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
OOS: Out-of-Specification
TAMC: Total Aerobic Microbial Count
TYMC: Total Yeast and Mold Count
HPLC: High-Performance Liquid Chromatography
6) Documents, if any
– QC Test Reports
– Batch Manufacturing Record
– Stability Testing Data
– OOS Investigation Reports
7) Reference, if any
– USP <61> Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests
– ICH Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products
– FDA Guidance for Industry: Quality Control Systems for Drug Product Manufacturing
8) SOP Version
Version 1.0