Good Manufacturing Practice (GMP) is a system ensuring that products are consistently produced and controlled according to quality standards. In the EU, GMP for medicinal products is governed by Directive 2003/94/EC and detailed in EudraLex Volume 4. Ovalab holds GMP certification from SÚKL (Certificate 74726/2023) for testing of human medicinal products.
Key Facts About GMP
- EU legal basis: Directive 2003/94/EC lays down principles and guidelines of GMP for medicinal products for human use and investigational medicinal products.
- EudraLex Volume 4: Contains the EU GMP Guide with Chapters 1–9 covering quality management, personnel, premises, documentation, production, quality control, outsourced activities, complaints, and self-inspection.
- Annexes: 20 annexes address specific topics including sterile manufacturing (Annex 1, revised 2022), biological products, and computerized systems (Annex 11).
- Quality control laboratories: Chapter 6 of EudraLex Vol. 4 specifies requirements for QC labs, including ISO/IEC 17025 principles for analytical testing.
- Inspections: National competent authorities (e.g., SÚKL in Czech Republic) conduct regular GMP inspections and issue certificates recognized across the EU via the EudraGMP database.
Implementation at Ovalab
Ovalab holds GMP certification issued by SÚKL (State Institute for Drug Control), Certificate 74726/2023, covering quality control testing of human medicinal products. The laboratory operates in compliance with EudraLex Volume 4, Chapter 6, ensuring validated analytical methods, qualified personnel, and full documentation traceability. Combined with ISO/IEC 17025:2017 accreditation (ČIA 537/2025), Ovalab meets the highest EU standards for pharmaceutical testing.
Frequently Asked Questions
What is the difference between GMP and ISO/IEC 17025?
GMP focuses on manufacturing and quality control processes for medicinal products, governed by EU Directive 2003/94/EC. ISO/IEC 17025 specifically addresses laboratory testing competence. Ovalab holds both certifications, covering manufacturing QC and independent analytical testing.
Who enforces GMP in the Czech Republic?
SÚKL (Státní ústav pro kontrolu léčiv / State Institute for Drug Control) is the national competent authority responsible for GMP inspections and certification of pharmaceutical facilities in the Czech Republic.
What does EudraLex Volume 4 cover?
EudraLex Volume 4 is the EU GMP Guide containing 9 chapters and 20 annexes. It provides interpretation of the principles in Directive 2003/94/EC, covering quality management, personnel, premises, documentation, production, quality control, outsourced activities, and self-inspection.
Is GMP certification required for pharmaceutical testing laboratories?
Yes. Laboratories performing quality control testing of medicinal products for release must hold GMP certification. This is separate from ISO/IEC 17025 accreditation and is specifically required under EU pharmaceutical legislation (Directive 2001/83/EC).
How does Ovalab maintain GMP compliance?
Ovalab undergoes regular SÚKL inspections, maintains validated analytical methods per Ph. Eur. monographs, operates with qualified personnel, and ensures full batch documentation and data integrity in compliance with EudraLex Volume 4 and Annex 11 (computerized systems).