Standard Operating Procedure for Light Exposure Testing for Gels
1) Purpose
The purpose of this SOP is to define procedures for conducting light exposure testing on gels to evaluate their stability under light exposure conditions, ensuring product quality and compliance with regulatory requirements.
2) Scope
This SOP applies to the Quality Control (QC) and Stability Testing departments responsible for performing light exposure testing on gels manufactured at the pharmaceutical manufacturing facility.
3) Responsibilities
Quality Control (QC): Conduct light exposure testing according to defined procedures and standards.
Stability Testing: Monitor and evaluate gel samples during light exposure to assess stability and shelf-life predictions.
Quality Assurance (QA): Oversee the implementation of light exposure testing procedures and ensure compliance with SOPs and regulatory guidelines.
4) Procedure
4.1 Preparation
4.1.1 Gather gel samples from representative batches with documented batch/lot numbers and formulations.
4.1.2 Ensure samples are labeled correctly and securely stored prior to testing.
4.2 Light Exposure Conditions
4.2.1 Define light exposure parameters based on regulatory guidelines and product specifications, including:
a) Light Source: Specify the type of light source (e.g., UV light, visible light).
b) Exposure Duration: Determine the duration of exposure
c) Intensity: Define the light intensity (e.g., lux) and distance from the light source.
4.3 Test Setup
4.3.1 Place gel samples in exposure chambers or cabinets equipped with controlled light sources.
4.3.2 Ensure proper monitoring and recording of light exposure conditions throughout the testing period.
4.4 Light Exposure Procedure
4.4.1 Initiate light exposure according to defined parameters, including exposure cycles and intervals.
4.4.2 Monitor samples for specified durations to simulate real-world storage and transportation conditions.
4.5 Sampling and Evaluation
4.5.1 Remove samples at defined intervals during and after light exposure cycles.
4.5.2 Perform analytical testing and evaluation of samples for changes in physical appearance, chemical stability, viscosity, and other relevant parameters.
4.6 Data Analysis and Reporting
4.6.1 Analyze test results to assess the impact of light exposure on gel stability and quality attributes.
4.6.2 Prepare detailed test reports documenting methodology, results, and conclusions from light exposure testing.
4.7 Non-Conformance and Corrective Actions
4.7.1 Document any deviations or out-of-specification results encountered during light exposure testing.
4.7.2 Initiate corrective actions to address root causes and prevent recurrence of stability-related issues.
4.8 Record Keeping and Archiving
4.8.1 Maintain comprehensive records of light exposure testing activities, including protocols, test results, and corrective actions.
4.8.2 Archive records in accordance with company policies and regulatory requirements.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
6) Documents, if any
– Light Exposure Testing Protocols and Procedures
– Test Reports and Data Sheets
– Stability Study Protocols and Reports
7) Reference, if any
– ICH guidelines on stability testing of pharmaceutical products
– Pharmacopoeial monographs (e.g., USP, Ph. Eur.) on stability testing conditions
– Company-specific stability testing protocols and guidelines
8) SOP Version
Version 1.0