🇦🇹 ValiPro: BASG/AGES (Austria) EU GMP Validation Services
Ensure Flawless Validation Documentation (eCTD Module 3) for BASG 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 BASG/AGES for both local Austrian manufacturers and foreign sites supplying the market.
Key compliance pillars for market access in Austria include:
National Authority (BASG/AGES): BASG awards the Marketing Authorization. AGES MEA evaluates the Quality dossier and conducts GMP/GDP inspections.
Manufacturing Standard (EU GMP/PIC/S): All manufacturing, importation, and testing activities must comply with the EU Guidelines to Good Manufacturing Practice.
Validation Requirements: Strict adherence to the lifecycle approach to validation, with mandatory compliance with EU GMP Annex 15 (Qualification and Validation).
Dossier Submission: Marketing Authorization Applications (MAA)—whether national, MRP/DCP, or supporting a centralized procedure—must be submitted in the eCTD format (electronically via BASG/AGES eService), with validation data residing in Module 3 (Quality/CMC).
🌟 Why Validation is Crucial for BASG/AGES Compliance
AGES MEA conducts both the scientific assessment of the Quality dossier and the on-site GMP inspections. Both activities center on documented validation to prove the manufacturing process is robust and the product is consistently safe and effective.
1. Mandatory Qualification and Validation (EU GMP Annex 15)
AGES MEA inspectors follow the PIC/S model, using EU GMP Annex 15 as the core standard. This mandates a lifecycle, risk-based approach to validation:
Process Validation Lifecycle: The modern, three-stage approach (ICH Q8, Q9, Q10) is required:
Process Design: Documented scientific understanding of the process.
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.
Qualification: All critical equipment and utilities must be fully Qualified (DQ, IQ, OQ, PQ). The process often includes a mandatory electronic submission of an Inspection of a Design Qualification (DQ) to the agency.
Cleaning Validation: Acceptance criteria must be scientifically justified, typically using Permitted Daily Exposure (PDE) limits derived from toxicological assessment, aligning with the strict requirements of Annex 15.
2. Marketing Authorization Submission (eCTD Module 3)
The Quality Module (Module 3) of the eCTD dossier submitted to BASG/AGES must contain technically robust validation data:
Analytical Method Validation (AMV): All analytical testing methods (for finished product release and stability) 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, reviewed via the ASMF or CEP.
Computer System Validation (CSV): Any computerized system impacting GMP data (e.g., LIMS, MES, SCADA) must be validated according to EU GMP Annex 11.
3. BASG/AGES GMP Audits
AGES MEA conducts routine GMP inspections of domestic sites and issues GMP certificates in the EudraGMDP database.
Audit Focus: Inspections focus on the Pharmaceutical Quality System (PQS) and verifying that the manufacturer's Validation Master Plan (VMP), protocols, and reports are executed, complete, and maintained to PIC/S standards.
QP Responsibility: The Qualified Person (QP) responsible for batch release must rely on satisfactory validation data to confirm the product was manufactured according to the MA. Auditors verify this reliance.
🎯 Compliance Focus: Who We Support
We work with manufacturers targeting the Austrian market:
Aseptic Manufacturers: Requiring specialized validation protocols for sterile products, aligned with the revised, stricter EU GMP Annex 1 (Manufacture of Sterile Medicinal Products), which became fully applicable in August 2024.
Foreign Manufacturers (Importers): Needing validation dossiers that meet the stringent BASG/AGES EU GMP requirements for the Marketing Authorization Application (MAA).
Local Austrian Manufacturers: Seeking comprehensive VMPs and execution protocols to maintain the highest level of compliance for routine AGES MEA inspections.
🛠️ Our Process Validation Services for BASG/AGES Compliance
We provide complete, scientifically sound, and EU-compliant validation documentation ready for BASG/AGES submission and audit defense.
ServiceBASG/AGES / 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 AGES MEA's scientific assessment.
🤝 Next Step: Secure BASG/AGES Validation Readiness
Ensure your validation documentation is robust, aligns with the mandatory EU GMP and ICH guidelines, and is ready to support your Austrian registration and GMP license application.
To receive a Technical Scope and Commercial Proposal tailored for your Austria 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 BASG/AGES