EU Commission Directive 2017/1572 - GMP Principles and Guidelines for Medicinal Products for Human Use

What it says

This Directive lays down the principles and guidelines of good manufacturing practice for medicinal products for human use, covering the pharmaceutical quality system, personnel, premises and equipment, documentation, production, quality control, outsourced activities, complaints and recalls, and self-inspection, with the detailed EU GMP Guide serving as its supporting guidance.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• It is the legal text that the EU GMP Guide chapters elaborate, so an inspection finding against the Guide traces back to a principle set here.
• It applies to manufacturers of medicinal products for human use in the EU and to products imported from outside it.
• It places responsibility for the quality system on the manufacturer, including the quality management obligations that Chapter 1 of the Guide describes.

What inspectors look for

• Whether the pharmaceutical quality system covers each of the principle areas the Directive sets out.
• Whether outsourced activities are controlled through written agreements and oversight.
• Whether complaints, recalls and self-inspection processes are operating and produce documented follow-up.

Related regulations