What Is GMP? Good Manufacturing Practice
GMP (good manufacturing practice) sets rules for consistent, controlled production of medicines and food. Learn key principles and the role of records.
Definition
GMP, or good manufacturing practice, is the set of regulations and guidelines that ensures medicines, food and similar products are produced consistently and controlled to quality standards. Documented procedures and records are central. Actarion supports GMP with controlled digital work instructions and an audit trail per execution.
Why does it matter on the shop floor?
- Batch records contain gaps and late entries.
- Training evidence is scattered across systems.
What is GMP?
GMP is a quality system for manufacturing, laid down in regulations such as EU GMP (EudraLex Volume 4) and US 21 CFR Parts 210/211.
GMP requires qualified staff, validated processes, controlled documents and complete records. 'If it is not documented, it did not happen' is a well-known GMP principle.
Key elements
- 1Approved procedures and instructions.
- 2Trained, qualified personnel.
- 3Complete, traceable records.
Example from the shop floor
In a tablet plant, each batch follows approved instructions. Every step, deviation and line clearance is recorded and reviewed before release.
How does Actarion help?
- Actarion provides version-controlled instructions and a time-stamped log per step.
- Digital, step-by-step work instructions generated from your SOPs with AI.
- AR guidance on tablets and AR glasses, with an audit trail per execution.
Frequently asked questions
cGMP means 'current' GMP, the term used by the US FDA.
Yes, GMP principles also apply in food and feed, alongside HACCP.
Yes, if the system meets data integrity requirements such as EU GMP Annex 11.
