ISO 17025 – Pharma GMP

Global & ISO-Based GMP Standards: A Step-by-Step Guide to Harmonizing FDA, EU/PIC/S and ISO Frameworks

digi — Wed, 05 Nov 2025 06:21:36 +0000

Global & ISO-Based GMP Standards: A Step-by-Step Guide to Harmonizing FDA, EU/PIC/S and ISO Frameworks Global & ISO-Based GMP Standards — Step-by-Step, Inspection-Ready Guide Global GMP operations rarely run on a single rulebook. A modern site must satisfy FDA cGMP (21 CFR 210/211), EU/UK GMP (EudraLex Vol. 4 and Annexes), and often PIC/S guidance—while leveraging...

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...

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...