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Links
GMP links omkring: måleteknik, metrologi, kalibrering, standarder mv.....
METROLOGY LINKS
FDA LINKS
ANDRE LINKS
1. American Society for Quality (ASQ)
2. American Society of Mechanical Engineers
3. DIA —Drug Information Association
5. International Society for Pharmaceutical Engineering (ISPE)
7. PDA —Parenteral Drug Association
FDA
2. Regulatory Requirements for Medical Device Calibration Programs
3. Measure for Measure: Where Does It Say That? – ASQ
5. Validation and Calibration Definitions and Terminology
6. Pay Close Attention To Equipment Calibration Certificates, FDA Says
7. GMP 11 Good Measurement Practice for Assignment and … – NIST
8. GMP-compliant Maintenance & Calibration
9. PTS – GMP Compliant Calibration Programs
10. Tutorial – 21 CFR Part 11 – Electronic Records/Electronic Signatures
11. Process Validation: General Principles and Practices
12. Inspections – Food and Drug Administration
13. Process Validation: Practical Aspects of the “New” FDA Guidance