🇧🇪 ValiPro: FAMHP (Belgium) EU GMP Validation Services
Ensure Flawless Validation Documentation (eCTD Module 3) for FAMHP 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 FAMHP for both local Belgian manufacturers and foreign sites supplying the EU market via Belgium (often a Qualified Person/batch release site).
Key compliance pillars for market access in Belgium include:
National Authority (FAMHP): The Belgian body responsible for granting Marketing Authorizations (MAA), manufacturer's and import licenses, and enforcing GMP through inspections.
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).
ICH Alignment: The FAMHP expects adherence to the lifecycle concepts defined in the ICH Quality Guidelines (Q8, Q9, Q10), ensuring a modern, risk-based approach to validation.
Dossier Submission: Applications for MAA must be submitted electronically in the eCTD format (often via CESP), with all quality and validation data contained within Module 3 (Quality/CMC).
🌟 Why Validation is Crucial for FAMHP Compliance
The FAMHP conducts thorough scientific reviews during the MAA process and high-standard GMP inspections. Validation is the essential evidence supporting the quality claims of the drug product.
1. Mandatory Qualification and Validation (EU GMP Annex 15)
The FAMHP inspection unit enforces compliance with the principles laid out in EU GMP Annex 15 (Qualification and Validation):
Process Validation Lifecycle: The lifecycle approach is mandatory, requiring three distinct stages. Retrospective validation is no longer acceptable.
Process Design: Establishing process understanding and control strategy.
Process Performance Qualification (PPQ): Executing 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.
Qualification: All critical equipment and utilities (e.g., Water Systems, HVAC, Sterilizers) must be fully Qualified through DQ, IQ, OQ, and PQ.
Cleaning Validation: Must be based on a toxicological assessment using Permitted Daily Exposure (PDE) limits, as mandated by Annex 15, moving beyond older arbitrary limits.
2. Marketing Authorization Submission (eCTD Module 3)
The Quality Module of the eCTD dossier submitted to the FAMHP must contain technically robust validation data:
Analytical Method Validation (AMV): All analytical testing methods (for release and stability) must be validated according to ICH Q2(R1) (or the upcoming Q2(R2)/Q14) principles.
API Validation: Active Pharmaceutical Ingredient (API) production must be validated according to ICH Q7 (API GMP) principles.
Aseptic Processes (Annex 1): For sterile products, compliance with the revised, stricter EU GMP Annex 1 (Manufacture of Sterile Medicinal Products) is essential, including validation of Aseptic Process Simulations (Media Fills).
3. FAMHP GMP Audits and QP Responsibility
The FAMHP conducts routine GMP inspections of domestic sites and issues GMP certificates in the EudraGMDP database.
Batch Release: For non-EU manufacturers, the Qualified Person (QP) in Belgium (or another EU state) responsible for batch release must confirm, based on validation data and the Quality System, that the product complies with GMP and the MA.
Audit Focus: Inspections focus on the robustness of the Pharmaceutical Quality System (PQS), the effectiveness of Change Control, and the maintenance of the Validated State of the facility and processes.
🎯 Compliance Focus: Who We Support
We work with manufacturers targeting the Belgian market:
Aseptic/Biotech Firms: Requiring specialized validation protocols for sterile products, aligned with the new, stricter EU GMP Annex 1.
Foreign Manufacturers (Importers): Needing validation dossiers that meet the stringent FAMHP/EU GMP requirements to support the MAA and the QP's batch release responsibility.
Local Belgian Manufacturers: Seeking comprehensive VMPs and execution protocols to maintain the highest level of compliance for routine FAMHP inspections.
🛠️ Our Process Validation Services for FAMHP Compliance
We provide complete, scientifically sound, and EU-compliant validation documentation ready for FAMHP submission and audit defense.
ServiceFAMHP / 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 FAMHP's scientific assessment.
🤝 Next Step: Secure FAMHP Validation Readiness
Ensure your validation documentation is robust, aligns with the mandatory EU GMP and ICH guidelines, and is ready to support your Belgian registration and GMP license application.
To receive a Technical Scope and Commercial Proposal tailored for your Belgium 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 FAMHP