FDA 21 CFR 211.160 – Pharma GMP

Don’t Clean Centrifuges While Sample Runs Are In Progress

digi — Sat, 25 Oct 2025 16:43:05 +0000

Don’t Clean Centrifuges While Sample Runs Are In Progress Don’t Perform Centrifuge Cleaning During Active Sample Runs Remember: Never clean centrifuges while samples are being processed — it risks imbalance, contamination, and invalid results in GMP testing environments. Why This Matters in GMP Centrifuges are precision instruments used to separate components based on density. Cleaning...

Never Leave Unused QC Reagents Unsegregated in GMP Laboratories

digi — Thu, 23 Oct 2025 18:12:17 +0000

Never Leave Unused QC Reagents Unsegregated in GMP Laboratories Don’t Leave Unused QC Reagents Unsegregated in GMP Laboratories Remember: Always segregate unused quality control reagents — improper storage can cause testing mix-ups, data errors, and compliance issues. Why This Matters in GMP QC reagents are essential to analytical testing, but if left unsegregated or improperly...

Discard Test Tubes with Illegible Markings to Prevent GMP Errors

digi — Wed, 08 Oct 2025 00:18:52 +0000

Discard Test Tubes with Illegible Markings to Prevent GMP Errors Don’t Use Test Tubes With Illegible Markings in GMP Laboratories Remember: Never use test tubes with unreadable labels or markings — unclear sample identity leads to invalid results and GMP data integrity breaches. Why This Matters in GMP Test tubes are used across microbiology, analytical...

Never Use Sampling Devices Past Expiry in GMP Testing

digi — Mon, 06 Oct 2025 00:27:51 +0000

Never Use Sampling Devices Past Expiry in GMP Testing Don’t Use Sampling Devices Beyond Their Expiry Date in GMP Labs Remember: Never use expired sampling tools — material degradation may compromise sample integrity and invalidate analytical results. Why This Matters in GMP Sampling devices — such as scoops, pipettes, syringes, filters, swabs, and sample bags...

Ensure External Calibration Certificates Are Traceable and GMP-Compliant

digi — Mon, 15 Sep 2025 14:37:02 +0000

Ensure External Calibration Certificates Are Traceable and GMP-Compliant Verify External Calibration Certificates for Traceability and Regulatory Compliance Remember: Always ensure external calibration certificates are traceable to national standards — they form the backbone of measurement accuracy in GMP labs. Why This Matters in GMP In pharmaceutical manufacturing and QC labs, equipment accuracy is essential for...

Set Up Automatic Alerts for Time-Sensitive GMP Activities

digi — Sun, 31 Aug 2025 05:26:10 +0000

Set Up Automatic Alerts for Time-Sensitive GMP Activities Implement Automated Alerts for Time-Critical GMP Activities Remember: Always use automated reminders for GMP time-bound activities — they help prevent non-compliance caused by missed sampling, calibration, or documentation events. Why This Matters in GMP Pharmaceutical operations are governed by numerous time-sensitive tasks — including equipment calibration, stability...

Maintain Calibration Traceability to National Standards in GMP Labs

digi — Sat, 30 Aug 2025 03:49:35 +0000

Maintain Calibration Traceability to National Standards in GMP Labs Ensure All Calibration Is Traceable to National or International Standards Remember: Always calibrate GMP instruments using standards traceable to national or international references — it ensures accuracy and meets regulatory expectations. Why This Matters in GMP Accurate measurement and reliable instrumentation are fundamental to pharmaceutical quality...