Top 10 CFR Reference
- 21 CFR 211.22(d)16-Procedures not in writing, fully followed
- 21 CFR 211.192119-Investigations of discrepancies, failures
- 21 CFR 211.100(a)116-Absence of Written Procedures
- 21 CFR 211.160(b)115-Scientifically sound laboratory controls
- 21 CFR 211.110(a)89-Control procedures to monitor and validate performance
- 21 CFR 211.67(b)73-Written procedures not established/followed
- 21 CFR 211.68(a)69-Calibration/Inspection/Checking not done
- 21 CFR 211.25(a)65-Training–operations, GMPs, written procedures
- 21 CFR 211.67(a)65-Cleaning / Sanitizing / Maintenance
- 21 CFR 211.100(b)64-SOPs not followed / documented
