Good Manufacturing Practice (GMP)
The manufacturing quality framework underlying most device and pharmaceutical regulatory approvals worldwide.
Overview
What GMP is and why it matters
Good Manufacturing Practice (GMP) refers to the systems and procedures ensuring products are consistently produced and controlled to quality standards. GMP requirements are embedded within most national device and pharmaceutical regulatory frameworks (FDA's Quality System Regulation, EU GMP, WHO GMP, Brazil's BGMP) rather than existing as one single global certificate.
Requirements
What you'll need
- Facility and equipment qualification
- Documented manufacturing procedures and batch records
- Personnel training and hygiene controls
- Quality control testing and product release procedures
- Change control and deviation management
- Periodic regulatory inspections
Typical timeline
6–18 months
Timeline depends heavily on existing facility maturity and which market's GMP framework applies.
Estimated cost
$20k–$200k
Facility upgrades to meet GMP standards, where needed, can be the single largest cost item in a market-entry budget.
Where this applies
Applicable countries
Related
Regulatory Pathways
FAQ
Frequently asked questions
Is GMP the same everywhere?+
No — GMP is a set of principles implemented differently by each regulator (FDA, EU, WHO, and country-specific authorities like Brazil's ANVISA each maintain their own GMP framework and inspection regime).
Reviewed launch planning
Ready to start your GMP project?
GHMAP structures your certification path, evidence gaps, and next actions — then connects you with a qualified consultant if you need one.
Professional review remains part of the workflow.