Standard Operating Procedure for Light and UV Monitoring
1) Purpose
This SOP outlines the procedures for monitoring light and ultraviolet (UV) radiation levels in pharmaceutical manufacturing areas to ensure product stability and compliance with regulatory requirements.
2) Scope
This SOP applies to all areas within the pharmaceutical facility where light and UV monitoring are critical to maintaining product quality and stability.
3) Responsibilities
The Facilities or Engineering department is responsible for monitoring light and UV radiation levels. Quality Assurance (QA) oversees compliance with this SOP and regulatory requirements.
4) Procedure
4.1 Monitoring Locations
- Identify critical areas and equipment requiring light and UV monitoring based on product sensitivity and regulatory guidelines.
- Install calibrated monitoring devices (e.g., UV meters, light sensors) at designated locations.
4.2 Monitoring Parameters
- Define monitoring parameters including intensity, wavelength range, and exposure duration based on product requirements and regulatory standards.
- Calibrate monitoring devices regularly according to validated procedures.
4.3 Monitoring Frequency
- Establish monitoring frequencies based on product stability testing requirements and environmental conditions.
- Record light and UV radiation readings at scheduled intervals (e.g., daily, weekly).
4.4 Data Analysis and Reporting
- Analyze monitoring data to assess compliance with specified light and UV exposure limits.
- Generate reports documenting monitoring results and any deviations from established limits.
4.5 Equipment Maintenance
- Maintain and calibrate monitoring equipment according to manufacturer specifications and validated procedures.
- Document equipment maintenance activities and ensure traceability of calibration certificates.
4.6 Alarm System (if applicable)
- Implement an alarm system to alert personnel of light and UV radiation levels exceeding acceptable limits, if applicable.
- Define procedures for responding to alarms and taking corrective actions.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
UV: Ultraviolet
6) Documents, if any
Light and UV Monitoring Plan, Calibration Records, Monitoring Reports
7) Reference, if any
Regulatory guidelines such as ICH Q1B Photostability Testing of New Drug Substances and Products, USP General Chapter Light and UV Radiation, FDA Guidance for Industry: Q1A(R2) Stability Testing of New Drug Substances and Products
8) SOP Version
Version 1.0
