🇳🇴 ValiPro: DMP (Norway) EU GMP Validation Services

Ensure Flawless Validation Documentation (eCTD Module 3) for DMP Registration and Pass Mandatory GMP Audits 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 Norwegian DMP for both local manufacturers and foreign sites supplying the Norwegian market.

Key compliance pillars for market access in Norway include:

• National Authority (DMP): The Norwegian Medical Products Agency assesses medicines and issues national Marketing Authorisations (MA) and licenses the manufacturing, import, and wholesale of medicines.

• Regulatory Alignment: Norway accepts MA decisions from the Centralised Procedure (CP), Decentralised Procedure (DCP), and Mutual Recognition Procedure (MRP), meaning compliance with the EU GMP is mandatory.

• Manufacturing Standard (EU GMP/PIC/S): All facilities must comply with the EU Guidelines to Good Manufacturing Practice and, specifically, Annex 15 (Qualification and Validation).

• Dossier Submission: Applications for MAA must document the medicinal product's quality, safety, and efficacy, with quality data (validation) residing in Module 3 (Quality/CMC) of the eCTD format.

🌟 Why Validation is Crucial for DMP Compliance

The DMP requires comprehensive validation to ensure the documented quality, safety, and efficacy of any product sold in Norway. This is verified during the registration review and on-site GMP inspections.

1. Mandatory Qualification and Validation (EU GMP Annex 15)

The Norwegian DMP inspection unit adheres to the principles laid out in EU GMP Annex 15 (Qualification and Validation). This mandates a lifecycle, risk-based approach to validation:

• Qualification Lifecycle: All critical equipment and utilities must be fully Qualified through the four stages: Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

• Process Validation Lifecycle: The lifecycle approach (ICH Q8, Q9, Q10) is mandatory:

  1. Process Design: Documented understanding of the manufacturing process.

  2. Process Performance Qualification (PPQ): Execution of commercial-scale batches to confirm process consistency.

  3. Continued Process Verification (CPV): Ongoing monitoring to assure the process remains in a validated state throughout the product life cycle.

• Aseptic Processes (Annex 1): For sterile products, compliance with the highly detailed requirements of the revised EU GMP Annex 1 (Manufacture of Sterile Medicinal Products) is essential, including validation of Aseptic Process Simulations (Media Fills).

2. Marketing Authorization Submission (eCTD Module 3)

The Quality Module of the eCTD dossier submitted to the DMP must contain detailed validation reports:

• Analytical Method Validation (AMV): All in-house analytical testing methods must be validated according to ICH Q2(R1) to ensure reliable QC results.

• API Validation: Active Pharmaceutical Ingredient (API) production must be validated according to ICH Q7 (API GMP) principles, including process and cleaning validation.

• Language Requirements: While the application must generally be written in English, the Norwegian language is mandatory for product information and labelling. Validation reports must support the quality claims for the product as marketed in Norway.

3. DMP GMP Audits

The DMP conducts routine GMP inspections of domestic sites and participates actively in the EU/EEA inspection system for foreign sites.

• Audit Focus: The inspections focus on the effectiveness of the Pharmaceutical Quality System (PQS), with a key check on the Validation Master Plan (VMP), the execution of validation protocols, and the management of deviations.

• PIC/S Alignment: The DMP follows globally recognized inspection standards, with a heavy focus on the completeness and maintenance of the validated status of the facility and its processes.

🎯 Compliance Focus: Who We Support

We work with manufacturers targeting the Norwegian market:

• Foreign Manufacturers (Importers): Requiring validation dossiers that meet the stringent DMP/EU GMP requirements for the Marketing Authorization Application (MAA).

• Local Norwegian Manufacturers: Needing comprehensive VMPs and execution of Qualification/Validation protocols to pass routine DMP GMP inspections.

• Biotech and Injectables: Requiring specialized validation protocols for sterile products, aligned with the new, stricter EU GMP Annex 1.

🛠️ Our Process Validation Services for DMP Compliance

We provide complete, scientifically sound, and EU-compliant validation documentation ready for DMP submission and audit defense.

ServiceDMP / 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.ICH Q7 API ValidationSpecialized validation for API manufacturers, including strict Cleaning Validation and Change Control Validation documentation.eCTD Module 3 Technical SupportStructuring and organizing validation summaries and data for inclusion in the eCTD Module 3 to pass the DMP's scientific assessment.

🤝 Next Step: Secure DMP Validation Readiness

Ensure your validation documentation is robust, aligns with the mandatory EU GMP and ICH guidelines, and is ready to support your Norwegian registration and GMP license application.

To receive a Technical Scope and Commercial Proposal tailored for your Norway 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 DMP