WHO-GMP/ EU-GMP: The Important Difference
It consists of the international /universal standards of product quality /safety.
It is the basic requirement for all manufacturers to implement GMP.
EU-GMP focuses on essential GMP controls along with country-specific regulations.
This includes additional regional regulatory qualifications.
WHO-GMP manufacturing –
It is the global authority that forms the backbone of the regulatory framework.
The core principles remain consistent across the globe.
It is a basic requirement that ensures product safety and quality.
The GMP goals include –
- Safeguards patient safety
- Ensures product quality
- It forms the base of regulatory approvals
- Reduces the risk of product recall.
EU-GMP manufacturing –
It is European Union Good Manufacturing Practices.
This includes the specifications for the sale of drugs in Europe.
Along with the basic GMP principles, EU-GMP includes variations in regulatory frameworks.
It is the difference in methodology –
- Variation in audits
- Documentation structure
- Quality systems
What are WHO-GMP regulations?
The GMP guidelines ensure consistent product quality in accordance with the intended use.
It includes-
- Process of manufacturing
- Raw material
- Training facilities
- Documentation
- Distribution
What are EU-GMP regulations?
These regulations apply to manufacturers, exporters, and distributors.
These are mandatory requirements for the sale of medicines in Europe.
These lay strong emphasis on –
- Pharmaceutical quality systems
- Risk management
- Documentation /traceability
- Trained professionals
Is the WHO-GMP standard of manufacturing enough for global export?
WHO-GMP is applicable in many countries.
However, the highly regulated market requires additional inspections and approvals.
The countries where only WHO-GMP is eligible –
It is highly beneficial for low-income countries, ensuring product quality.
It is acceptable in countries in Africa, the Middle East, and parts of Asia.
It also forms the basis of drug qualification by the UN and International health agencies.
The countries that require additional approvals –
The additional regulatory frameworks are required in –
UK, USA, and European markets.
These are the stringent markets.
They individually assess the manufacturing facilities.
They enforce distinct local documentation based on the region.
Which is the WHO-GMP /EU-GMP certified pharmaceutical manufacturer?
Aprazer Healthcare is the leading pharmaceutical company from India.
It specializes in manufacturing GMP-compliant drugs.
We are the leading drug supplier to the international market.
Our regulatory team has expertise in drug approvals in different targeted markets, technical standards, and documentation demands.
Implementing cutting–edge technical flow, our manufacturing units are compliant with EU regulatory norms, providing complete documentation and regulatory support.
Our fully automated systems hold a zero-tolerance stance on data gaps, favoring EU-GMP steep technological requirements.
