🇬🇷 ValiPro: EOF (Greece) EU GMP Validation Services

Ensure Flawless Validation Documentation (eCTD Module 3) for EOF 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 EOF for both local Greek manufacturers and foreign sites supplying the market.

Key compliance pillars for market access in Greece include:

• National Authority (EOF): The Greek body responsible for granting Marketing Authorizations (MAA), conducting the scientific assessment of efficacy, safety, and quality (CMC), 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 EOF 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: MAA must be submitted in the Common Technical Document (CTD) format, specifically the eCTD format, with all validation data contained within Module 3 (Quality/CMC).

🌟 Why Validation is Crucial for EOF Compliance

Validation is the documented proof of quality. The EOF relies on this evidence both for the initial assessment of the medicine's quality in the registration dossier and for ongoing compliance verified during GMP inspections.

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

EOF inspectors enforce the principles of EU GMP Annex 15, requiring a scientific, risk-based, and lifecycle approach to validation:

• Process Validation Lifecycle: The modern, three-stage approach is mandatory. The EOF will verify that the process is consistently capable of producing a finished product meeting its predetermined specifications.

  1. Process Design

  2. Process Performance Qualification (PPQ)

  3. Continued Process Verification (CPV)

• Qualification: All critical equipment and utilities must be fully Qualified (DQ, IQ, OQ, PQ) according to defined, approved protocols.

• Cleaning Validation: Acceptance criteria for cleaning 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. Scientific Assessment of Quality (eCTD Module 3)

The Quality Module of the MAA dossier submitted to the EOF is scientifically assessed to ensure the manufacturing process is under control:

• Analytical Method Validation (AMV): All analytical testing methods (for finished product, stability, and control) must be validated according to ICH Q2(R1) principles, a standard often emphasized for generic drug applications involving bioequivalence studies.

• Bioequivalence Studies: For generic drugs, validation of the manufacturing process is essential to support the quality and consistent dosage that leads to the successful outcome of the bioequivalence studies.

3. EOF GMP Audits

The EOF conducts routine and targeted GMP inspections of Greek manufacturing sites and actively participates in the EU-wide system of GMP inspections for foreign sites.

• Audit Focus: Inspections focus on the Pharmaceutical Quality System (PQS), ensuring the Validated State of the facility is maintained through robust Change Control and Deviation Management.

• Falsified Medicines Directive (FMD): The EOF, in collaboration with the Hellenic Medicines Verification Organization (HMVO), rigorously enforces compliance with the Falsified Medicines Directive, ensuring systems (including data integrity/CSV for serialization) are validated.

🎯 Compliance Focus: Who We Support

We work with manufacturers targeting the Greek market:

• Generic Drug Manufacturers: Requiring robust, internationally compliant Process Validation and Analytical Method Validation to support quality claims in the MAA.

• Aseptic/Sterile Manufacturers: Requiring specialized validation protocols aligned with the new, stricter EU GMP Annex 1 (Manufacture of Sterile Medicinal Products).

• Foreign Manufacturers (Importers): Needing validation dossiers that meet the stringent EOF/EU GMP requirements to support the MAA and the Qualified Person's batch release responsibility.

🛠️ Our Process Validation Services for EOF Compliance

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

ServiceEOF / 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 EOF's scientific quality assessment.

🤝 Next Step: Secure EOF Validation Readiness

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

To receive a Technical Scope and Commercial Proposal tailored for your Greece 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 EOF