Quality Control and Quality Assurance for Sunlamp Products and UV Lamps
This guidance provides recommendations for quality control and quality assurance programs for manufacturers of sunlamp products and ultraviolet lamps. It aims to help manufacturers comply with both the Good Manufacturing Practices (GMP) requirements and the Federal performance standard for sunlamp products (21 CFR 1040.20).
Recommended Actions
- Establish and document a comprehensive quality assurance program
- Implement preproduction evaluation procedures including:
- Design review
- Component evaluation
- Prototype testing
- Develop and implement production testing procedures:
- Qualitative tests (labels, functions, etc.)
- Quantitative tests (irradiance, timer accuracy, etc.)
- Sampling plans if not testing 100%
- Create documentation system for:
- Test procedures and results
- Component specifications
- Production processes
- Quality control records
- Establish audit procedures and schedule (minimum yearly)
- Implement training program for quality assurance and production personnel
- Develop procedures for handling non-conforming products
- Create system for maintaining records for required retention periods (5 years for radiation control records)
- Establish calibration program for test equipment
- Develop procedures to verify compliance with labeling requirements
Key Considerations
Non-clinical testing
- Preproduction evaluation and testing of product design and prototypes
- Testing of components and materials from other manufacturers
- Production testing including qualitative and quantitative tests
- Testing for irradiance ratio limits
- Timer accuracy testing
- Testing of protective eyewear transmittance
Human Factors
- Evaluation of protective eyewear for adequate visibility of controls and labels
- Assessment of control locations for user accessibility
- Verification that users can manually terminate radiation emission
Labelling
- Required warning labels with specific content about UV radiation hazards
- Identification labels with manufacturer info and date of manufacture
- Certification labels stating compliance with standards
- Instructions for use with exposure schedules and safety information
Safety
- Maximum exposure time limits based on minimal erythema dose (MED)
- Timer accuracy requirements (±10% of maximum interval)
- Irradiance ratio limits for UV radiation
- Requirements for protective eyewear transmittance
Other considerations
- Quality assurance program documentation requirements
- Personnel training requirements
- Audit procedures and frequency
- Record keeping requirements
Relevant Guidances
- Applicability of Sunlamp Performance Standards to UVA Tanning Products (Revoked)
- Recordkeeping Requirements and Exemptions for Portable Home Sunlamp Products and UV Lamps
- Regulatory Requirements and Enforcement Actions for Defective Sunlamp Products Manufactured Before May 7, 1980
- Exemptions from Reporting Requirements for Limited Production of Sunlamp Products for Commercial Use
- Inspection and Field Testing Requirements for Sunlamp Products and UV-Emitting Devices
- Compatibility Criteria for Replacement UV Lamps in Sunlamp Products
Related references and norms
- MIL-STD-105D: Sampling Procedures and Tables for Inspection by Attributes
- MIL-STD-414: Sampling Procedures and Tables for Inspection by Variables for Percent Defective
Original guidance
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