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Medical Device Cleanroom GMP and FDA Standards
Personnel must follow strict gowning procedures, undergo training on cleanroom protocols, and minimize movement within the cleanroom to prevent contamination.
Key Requirements:
- Strict gowning procedures for all personnel
- Comprehensive cleanroom protocol training
- Minimized movement to reduce contamination risk
- Regular health monitoring of personnel
Equipment Qualification and Validation
All equipment used in the cleanroom must be properly qualified and validated to ensure it performs as expected and doesn’t introduce contaminants.
Installation Qualification (IQ)
Verifies equipment is properly installed according to specifications.
Operational Qualification (OQ)
Confirms equipment operates as intended within specified parameters.
Performance Qualification (PQ)
Demonstrates consistent performance under routine production conditions.
Documentation and Record Keeping
Comprehensive documentation is crucial for demonstrating compliance with GMP and FDA regulations. This includes standard operating procedures (SOPs), equipment maintenance logs, personnel training records, and validation protocols.
| Document Type | Purpose | Retention Period |
|---|---|---|
| Standard Operating Procedures | Define cleanroom processes | Permanent |
| Equipment Logs | Track maintenance and calibration | Device lifetime + 2 years |
| Training Records | Document personnel qualifications | 5 years |
| Validation Protocols | Verify process effectiveness | Device lifetime + 2 years |
Cleaning and Sanitization
Regular cleaning and sanitization procedures are essential to maintain a clean environment. This includes the use of appropriate cleaning agents and validated cleaning procedures.
