🇩🇰 ValiPro: DMA (Denmark) EU GMP Validation Services
Ensure Flawless Validation Documentation (Module 3) for DMA Registration and Pass Mandatory GMP Inspections by Adhering to PIC/S GMP and ICH Guidelines.
ValiPro provides expert Process Validation services specifically tailored to meet the strict EU GMP requirements enforced by the Danish Medicines Agency for both local manufacturers and foreign sites supplying the Danish market.
Key compliance pillars for market access in Denmark include:
National Authority (DMA): The Danish Medicines Agency is responsible for granting marketing authorizations, manufacturer's licenses, and conducting GMP inspections in Denmark.
Manufacturing Standard (EU GMP/PIC/S): All manufacturing and importation activities must comply with the EU Guidelines to Good Manufacturing Practice and, specifically, Annex 15 (Qualification and Validation).
ICH Alignment: The DMA aligns its technical expectations (Quality/CMC) with the International Council for Harmonisation (ICH) guidelines, including the lifecycle approach to validation (ICH Q8, Q9, Q10).
Dossier Submission: All applications for Marketing Authorization (MAA) must be submitted electronically in the eCTD format via CESP, with validation data residing in Module 3 (Quality/CMC).
🌟 Why Validation is Crucial for DMA Compliance
Denmark's robust regulatory system requires clear, scientifically sound, and audit-ready documentation to prove product consistency and quality. Validation is the foundation of this proof.
1. Mandatory Qualification and Validation (EU GMP Annex 15)
The DMA's inspection unit, following the PIC/S model, uses Annex 15 as the definitive checklist for reviewing validation status.
Qualification Lifecycle: All critical equipment and utilities must be fully Qualified (DQ, IQ, OQ, PQ). Special emphasis is placed on the validation of computerized systems (CSV) under EU GMP Annex 11.
Process Validation Lifecycle: The modern, lifecycle approach to validation is mandatory:
Process Design: Documented understanding of the manufacturing process based on Pharmaceutical Development (ICH Q8).
Process Performance Qualification (PPQ): Execution of commercial-scale batches to confirm process consistency.
Continued Process Verification (CPV): Ongoing monitoring to assure the process remains in a validated state throughout the product life cycle.
Cleaning Validation: Must be scientifically justified, typically using Health-Based Exposure Limits (HBEL) or Permitted Daily Exposure (PDE) values to set stringent, toxicologically sound acceptance criteria.
2. Marketing Authorization Submission (CTD Module 3)
The DMA performs a rigorous scientific assessment of the Quality Module (Module 3) of the CTD/eCTD dossier. Validation data must support every claim regarding the process and controls.
3.2.P.3 Manufacturing Process: Detailed documentation of the manufacturing process, supported by a summary of Process Validation protocols and results.
3.2.S.2.5 Process Validation and/or Evaluation (API): For Active Pharmaceutical Ingredients (APIs), the validation documentation must align with ICH Q7 (API GMP) principles, including process and cleaning validation.
Analytical Method Validation (AMV): All analytical procedures used for testing the drug substance and drug product must be fully validated according to ICH Q2(R1).
3. DMA GMP Audits (Inspections)
The DMA conducts routine and pre-licensing GMP inspections on Danish facilities and contributes to the EU system for inspecting foreign manufacturers.
Audit Focus: Inspections focus on the robustness of the Pharmaceutical Quality System (PQS) and verifying that the VMP and associated validation protocols and reports are executed, complete, and maintained.
Electronic Submission Requirements: Denmark requires electronic submission in eCTD format via CESP. The technical validation of the dossier ensures that the documents, including validation files, comply with ICH/EMA technical specifications.
🎯 Compliance Focus: Who We Support
We work with manufacturers targeting the Danish market:
Biotech and Injectables: Requiring specialized validation protocols for sterile products, aligned with the revised, stricter EU GMP Annex 1 (Manufacture of Sterile Medicinal Products).
Foreign Manufacturers (Importers): Needing validation dossiers that meet the stringent DMA/EU GMP requirements for the Marketing Authorization Application (MAA) and Importer's License.
Local Danish Manufacturers: Seeking support to maintain the highest level of Continued Process Verification (CPV) and audit readiness for DMA inspections.
🛠️ Our Process Validation Services for DMA Compliance
We provide complete, scientifically sound, and EU-compliant validation documentation ready for DMA submission and audit defense.
ServiceDMA / EU GMP / PIC/S FocusPIC/S VMP & PVDevelopment of a Validation Master Plan (VMP) and Process Performance Qualification (PPQ) protocols aligned with EU GMP Annex 15.Aseptic Processing ValidationSpecialized validation for sterile manufacturers, including Aseptic Process Simulation (Media Fills), aligning with the new EU GMP Annex 1.CSV & Annex 11 ComplianceComputer System Validation (CSV) for all QC/QA and manufacturing software/systems, ensuring adherence to EU GMP Annex 11.CTD Module 3 Technical SupportStructuring and organizing validation summaries and data for inclusion in the eCTD Module 3 to pass the DMA's scientific assessment.
🤝 Next Step: Secure DMA Validation Readiness
Ensure your validation documentation is robust, aligns with the mandatory EU GMP and ICH guidelines, and is ready to support your Danish registration and GMP license application.
To receive a Technical Scope and Commercial Proposal tailored for your Denmark project, simply provide:
Product: Active Pharmaceutical Ingredient (API) or Finished Formulation (e.g., sterile injectable, tablet)
Application Type: National MAA / Decentralized Procedure (DCP) / Mutual Recognition Procedure (MRP)
Manufacturing Process: Overview of critical steps and control strategy
Timeline: Target submission date for DMA