🇳🇱 ValiPro: MEB/IGJ (Netherlands) EU GMP Validation Services
Ensure Flawless Validation Documentation (eCTD Module 3) for MEB 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 IGJ and the quality assessment standards of the MEB for manufacturers supplying the Dutch market.
Key compliance pillars for market access in the Netherlands include:
National Authorities: The MEB assesses the validation data in the registration dossier. The IGJ inspects the site and issues the GMP Certificate (entered in the EudraGMDP database).
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).
Validation Requirements: The required standard is the lifecycle approach to validation (ICH Q8, Q9, Q10), ensuring continuous control of the manufacturing process.
Dossier Submission: MAA must be submitted in the eCTD format (via CESP), with all quality and validation data contained within Module 3 (Quality/CMC).
🌟 Why Validation is Crucial for MEB/IGJ Compliance
The MEB requires sufficient proof of the medicine's quality and the consistency of its production process in the MAA. The IGJ confirms this on-site via inspection, relying heavily on the executed validation program.
1. Mandatory Qualification and Validation (EU GMP Annex 15)
The IGJ strictly enforces the principles of EU GMP Annex 15, which mandates a documented, lifecycle approach to validation:
Process Validation Lifecycle: The modern, three-stage approach is required, and the IGJ will verify evidence of all stages:
Process Design: Documenting process understanding and the control strategy.
Process Performance Qualification (PPQ): Confirmation of commercial-scale consistency.
Continued Process Verification (CPV): Ongoing monitoring to assure the validated state is maintained. Retrospective validation is no longer considered an acceptable approach.
Qualification: All critical facilities, utilities, and equipment must be qualified (DQ, IQ, OQ, PQ). This includes critical utilities like Water Systems (which must meet Water for Injection (WFI) quality standards for sterile processes) and HVAC systems.
Cleaning Validation: Acceptance criteria must be scientifically justified and documented in a risk assessment, with limits often based on a toxicological evaluation using Permitted Daily Exposure (PDE) limits.
2. Quality Dossier Assessment by the MEB (eCTD Module 3)
The MEB assesses whether the submitted dossier provides assurance on the quality of the medicine and its production process:
Analytical Method Validation (AMV): All analytical testing methods (for release and stability) must be validated according to ICH Q2(R1) principles to ensure reliable quality control results.
Biotechnology Products: For active substances derived from biotechnology, the MEB (following EMA guidance) requires validation data covering process characterization and process verification as part of the submission (ICH Q11).
Site Clearance: For manufacturers included in an MAA, the MEB requests the IGJ to issue a site clearance (a form of advice) regarding the manufacturer's GMP status, relying on the inspection results.
3. IGJ GMP Inspections
The IGJ conducts periodic GMP inspections at all medicinal product manufacturers in the Netherlands and also conducts inspections outside the EU for sites supplying the Dutch market.
Audit Focus: Inspections center on the Pharmaceutical Quality System (PQS), ensuring the Validation Master Plan (VMP) is executed, and that deviations, out-of-specifications (OOS), and changes (Change Control) related to validated systems are handled appropriately.
Aseptic Compliance: For sterile manufacturers, the IGJ verifies compliance with the highly detailed requirements of the revised EU GMP Annex 1 (Manufacture of Sterile Medicinal Products).
🎯 Compliance Focus: Who We Support
We work with manufacturers targeting the Dutch market:
Aseptic/Biotech Firms: Requiring specialized validation protocols for sterile products, aligned with the new, stricter EU GMP Annex 1.
Foreign Manufacturers (Importers): Needing robust validation documentation to support the MAA and the Qualified Person's (QP's) batch release responsibility in the EU.
Local Dutch Manufacturers: Seeking comprehensive VMPs and execution protocols to maintain the highest level of compliance for routine IGJ inspections and ensure their GMP Certificate remains valid.
🛠️ Our Process Validation Services for MEB/IGJ Compliance
We provide complete, scientifically sound, and EU-compliant validation documentation ready for MEB submission and IGJ audit defense.
ServiceMEB/IGJ / 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.Cleaning Validation (PDE/ADE)Calculation of health-based limits (PDE/ADE) and execution of Cleaning Validation protocols to meet the stringent Annex 15 requirements.eCTD Module 3 Technical SupportStructuring and organizing validation summaries and data for inclusion in the eCTD Module 3 to pass the MEB's scientific quality assessment.
🤝 Next Step: Secure MEB/IGJ Validation Readiness
Ensure your validation documentation is robust, aligns with the mandatory EU GMP and ICH guidelines, and is ready to support your Dutch registration and GMP license application.
To receive a Technical Scope and Commercial Proposal tailored for your Netherlands 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 the MEB