🇭🇺 ValiPro: OGYÉI (Hungary) EU GMP Validation Services

Ensure Flawless Validation Documentation (Module 3) for Marketing Authorization and Pass OGYÉI's 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 OGYÉI, ensuring that manufacturing processes (for both local Hungarian production and imported drugs) are compliant with EU standards.

Key compliance pillars for market access in Hungary include:

• National Authority (OGYÉI): The Hungarian licensing and enforcement body for medicinal products, operating under the EU regulatory system.

• Manufacturing Standard (EU GMP): Compliance with the EU Guidelines to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, which includes the PIC/S Guide.

• Validation Requirements: Strict adherence to EU GMP Annex 15 (Qualification and Validation) and the ICH Quality guidelines (Q8, Q9, Q10) for a lifecycle approach to validation.

• Dossier Submission: All marketing authorization applications (MAA) must be submitted in the Common Technical Document (CTD) format, with validation data residing in Module 3 (Quality/CMC).

🌟 Why Validation is Crucial for OGYÉI Compliance

Validation is the core element of the Pharmaceutical Quality System (PQS) that OGYÉI auditors examine to verify that a drug is consistently manufactured to its registered specifications.

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

The EU GMP Annex 15 is the definitive standard for validation activities in Hungary. OGYÉI auditors will expect comprehensive documentation of the validation lifecycle:

• Validation Master Plan (VMP): A VMP is required to define the manufacturer's validation policy and strategy based on Quality Risk Management (QRM).

• Qualification Lifecycle: Equipment and critical utilities must be formally Qualified through:

  • Design Qualification (DQ): Documented evidence that the design meets GMP requirements.

  • Installation Qualification (IQ): Documented evidence that the system is installed correctly.

  • Operational Qualification (OQ): Documented evidence that the system operates as intended within specified limits.

  • Performance Qualification (PQ): Documented evidence that the system performs consistently under routine operating conditions.

• Process Validation Lifecycle: The validation must cover the three stages of the modern process validation lifecycle: Process Design, Process Performance Qualification (PPQ), and Continued Process Verification (CPV).

2. Marketing Authorization Submission (CTD Module 3)

For both national and EU-centralized procedures reviewed by OGYÉI, the dossier must contain scientifically sound validation reports:

• API Compliance: For Active Pharmaceutical Ingredients (APIs), the validation must align with ICH Q7 (API GMP), including rigorous API Process Validation and Cleaning Validation.

• Method Validation: All in-house analytical testing methods (for finished product release and stability) must be validated according to ICH Q2(R1) (Validation of Analytical Procedures).

• Computer System Validation (CSV): Any computerized system used in manufacturing, testing, or documentation control (e.g., LIMS, MES, SCADA) must be validated according to EU GMP Annex 11.

3. OGYÉI GMP Audits

OGYÉI conducts routine and pre-licensing GMP inspections on domestic sites and may participate in inspections of foreign sites manufacturing products for the EU.

• Audit Focus: Inspections focus on the Quality System and the demonstrable control over critical processes. The validation files (VMP, Protocols, and Reports) are the primary evidence reviewed.

• Deficiency Classification: Deficiencies found are classified as Critical, Major, or Other, with Critical or Major findings often relating directly to deficient validation (e.g., lack of cleaning validation data, unqualified water system).

🎯 Compliance Focus: Who We Support

We work with manufacturers targeting the Hungarian market:

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

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

• API Suppliers: Ensuring their API production and cleaning processes are validated to ICH Q7 standards for drug master file (DMF) referencing.

🛠️ Our Process Validation Services for OGYÉI Compliance

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

ServiceOGYÉI / 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.API Validation (ICH Q7)Specialized validation for API manufacturers, including strict Cleaning Validation and Change Control Validation documentation.Module 3 Technical SupportStructuring and organizing validation summaries and data for inclusion in the CTD Module 3 to pass OGYÉI's scientific assessment.

🤝 Next Step: Secure OGYÉI Validation Readiness

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

To receive a Technical Scope and Commercial Proposal tailored for your Hungary 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 OGYÉI