GMP

Good Manufacturing Practice

GMP exists because you cannot test quality into a product. Finished-product testing samples a tiny fraction of a batch and cannot detect most of what can go wrong — cross-contamination, a mix-up, a degraded intermediate, an unrecorded deviation. So the regulations govern the conditions of manufacture instead: premises and equipment, personnel and training, documentation, materials control, production, quality control, complaints and recalls, self-inspection, and outsourced activities.

The "c" in cGMP is doing real work. Current means the expectation moves with what is technologically and scientifically achievable — a control that was acceptable a decade ago may not be today. That is why the regulations themselves are written broadly while guidance, inspection practice, and industry standards carry the detail.

The regimes converge more than they differ. The US codifies GMP in 21 CFR 210/211 for finished pharmaceuticals; the EU in EudraLex Volume 4 with its annexes; PIC/S PE 009 harmonises the inspection standard across 50-plus authorities; ICH Q7 covers active pharmaceutical ingredients; and WHO GMP underpins many emerging markets. A site built to EU or PIC/S standards is largely aligned everywhere, with local documentation and language requirements being the usual gap.

• —Quality is built in through controlled conditions — it cannot be tested in at the end.
• —Scope: premises, equipment, personnel, documentation, materials, production, QC, complaints/recalls, self-inspection, outsourcing.
• —"Current" means the bar rises as science and technology advance.
• —US 21 CFR 210/211 · EU EudraLex Vol. 4 + annexes · PIC/S PE 009 · ICH Q7 for APIs · WHO GMP.
• —The quality unit must be independent and have the authority to reject — structurally, not nominally.
• —Written procedures, followed and recorded contemporaneously, are the evidentiary backbone.

US: 21 CFR Parts 210 and 211 (and 21 CFR 4 for combination products); EU: EudraLex Volume 4 (EU GMP Guide) Parts I–III and its annexes; PIC/S PE 009 (GMP Guide); ICH Q7 for active pharmaceutical ingredients; WHO GMP (TRS series).