EU-GMP Journey
Building toward international GMP expectations.
The journey
Building Toward International GMP Expectations
Grandene is undertaking a structured quality and manufacturing development program with the objective of aligning relevant operations with European Good Manufacturing Practice expectations.
The program is supported by specialist international consultancy and is intended to strengthen facility readiness, pharmaceutical quality systems, documentation, qualification, validation, training and inspection preparedness.
International consultancy
Working with Integria Pharma Hungary
Grandene is working with Integria Pharma Hungary Kft. on an EU-GMP consultancy program covering the defined manufacturing scope. The engagement supports the development of systems and practices required for a structured journey toward EU-GMP readiness.
Roadmap
Key workstreams
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01
GMP gap assessment and roadmap
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02
Facility and workflow review
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03
Quality-system development
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04
Documentation and SOP framework
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05
Qualification and validation strategy
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06
Personnel training
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07
Inspection-readiness preparation
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08
Continuous compliance improvement
For Grandene, EU-GMP readiness is not treated as a one-time project. It is part of a long-term commitment to disciplined pharmaceutical manufacturing and continuous quality improvement.
GMP & regulatory framework
Built toward recognised GMP standards
Grandene's facility, quality systems and documentation are being developed in line with the following GMP frameworks. Certification status is communicated only after formal approval by the relevant authority.
EU-GMP
European Union Good Manufacturing Practice
EAEU GMP
Eurasian Economic Union GMP requirements
Uzbek GMP
Good Manufacturing Practice of the Republic of Uzbekistan
International Collaboration
Creating pharmaceutical capability with purpose, precision and partnership.