A Comprehensive Guide to the EudraGMDP Database and GMP Certification in the EU

Maintaining compliance with Good Manufacturing Practice (GMP) is a regulatory prerequisite for pharmaceutical manufacturers seeking to operate within or export to the European Union. The EudraGMDP database, maintained by the European Medicines Agency (EMA), is the official EU portal for tracking GMP certificates, inspection outcomes, and non-compliance declarations. This article provides a detailed overview of the EudraGMDP database, how GMP certification is documented, and how manufacturers and regulators use it to ensure transparency and accountability in the pharmaceutical supply chain.

What Is the EudraGMDP Database?

• A publicly accessible regulatory database that houses GMP and GDP (Good Distribution Practice) compliance information
• Managed by the EMA and populated by EU/EEA national competent authorities
• Provides information on:
  • GMP Certificates
  • Non-Compliance Statements
  • Inspection Planning
  • Manufacturing Authorizations
• Updated in real time as inspections and certifications are completed

Why Is EudraGMDP Important?

• Enhances transparency of GMP compliance status for facilities worldwide
• Allows regulatory agencies, Qualified Persons (QPs), and importers to verify current GMP status
• Enables marketing authorization holders (MAHs) to evaluate manufacturing partners
• Facilitates harmonization across EU Member States under the decentralized regulatory model

Accessing and Navigating the EudraGMDP Portal:

• Visit https://eudragmdp.ema.europa.eu
• Search options include:
  • Site name or address
  • Activity (e.g., manufacture of sterile products, API production)
  • Competent authority
  • GMP certificate or non-compliance statement type
• Results include PDF documents detailing scope, findings, and validity

What Is a GMP Certificate in the EU?

• Issued after successful inspection by an EU Member State’s competent authority
• Confirms the facility’s compliance with EU GMP Parts I (Finished Products), II (APIs), and applicable Annexes
• Typically valid for 2–3 years, subject to ongoing compliance
• Includes site activities, authorized dosage forms, and date of inspection

GMP Certificate Structure:

• Issuing Authority: NCA such as MHRA, BfArM, ANSM, AIFA, etc.
• Scope of Authorization: Lists activities and dosage forms covered
• Validity Period: Indicates whether inspection is recent or certificate is historic
• Remarks Section: Notes special conditions or linked licenses

What Is a Non-Compliance Statement?

• Issued when a facility is found critically deficient or poses risk to public health
• Lists specific GMP failures and actions recommended (e.g., certificate suspension)
• Appears on EudraGMDP and notifies all EU regulatory bodies and MAHs
• Triggers regulatory actions such as recalls, import suspension, and potential re-inspection

Implications for Manufacturers:

• Being listed with an active GMP certificate boosts trust and speeds regulatory approvals
• Non-compliance listings can block product release into EU markets
• Firms must maintain continuous inspection readiness and CAPA documentation
• Periodic internal audits should mimic EU inspection protocols to prevent compliance erosion

EMA’s Role in EudraGMDP Oversight:

• Centralizes data submission from all Member States and EEA partners
• Manages database updates and quality control for publicly available records
• Supports joint inspection reporting and MRA partner recognition (e.g., FDA, TGA)
• Coordinates non-compliance tracking across centralized marketing authorizations

How MA Holders and QPs Use EudraGMDP:

• QPs verify GMP status before batch release into the EU
• MAHs evaluate contract manufacturing organizations (CMOs) for compliance status
• Due diligence for supply chain audits and partner selection
• Helps prepare for renewals, variations, and GMP updates in submissions

Maintaining GMP Certification Status:

1. Track inspection dates and prepare for expected re-inspections (every 2–3 years)
2. Ensure change controls and deviations are logged and CAPAs closed on time
3. Align all internal procedures with EU GMP Part I, Part II, and applicable Annexes
4. Train cross-functional teams in handling inspections and maintaining documentation readiness
5. Prepare for visibility—regulatory bodies and industry stakeholders access your EudraGMDP listing

Best Practices for Utilizing the Database:

• Bookmark site profiles and set up alerts for changes in GMP status
• Regularly download your own GMP certificate to share with clients and partners
• Monitor competitors or suppliers for non-compliance flags
• Incorporate GMP certificate status into supplier qualification SOPs

Conclusion:

The EudraGMDP database is a cornerstone of pharmaceutical GMP transparency in Europe. It empowers regulators, companies, and Qualified Persons to make informed decisions on compliance and partnership. For manufacturers, maintaining a clean and current presence in the database is more than a formality—it is a public affirmation of quality and regulatory trustworthiness. By aligning with EU GMP standards and maintaining inspection readiness, firms can leverage EudraGMDP to accelerate global market access and safeguard product integrity.