🇸🇮 ValiPro: JAZMP (Slovenia) EU GMP Validation Services

Ensure Flawless Validation Documentation (eCTD Module 3) for JAZMP Registration and Pass 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 JAZMP for both local Slovenian manufacturers and foreign sites supplying the market.

Key compliance pillars for market access in Slovenia include:

• National Authority (JAZMP): Responsible for evaluating the Quality (CMC) dossier for Marketing Authorization Applications (MAA) and conducting comprehensive GMP inspections to issue/renew the GMP Certificate.

• Manufacturing Standard (EU GMP/PIC/S): All facilities must comply with the EU Guidelines to Good Manufacturing Practice (EudraLex, Volume 4), particularly Annex 15 (Qualification and Validation).

• MRA Equivalence: Slovenia's inclusion in the EU-US MRA means the standard of evidence for validation is of high international repute, facilitating easier trade with other MRA partners.

• Dossier Submission: MAA must be submitted in the eCTD format, with all quality and validation data contained within Module 3 (Quality/CMC).

🌟 Why Validation is Crucial for JAZMP Compliance

Validation is the core evidence JAZMP uses to determine if a manufacturer can consistently produce a safe, effective, and high-quality product.

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

JAZMP inspectors strictly enforce the principles of EU GMP Annex 15, which mandates a documented, lifecycle approach to validation:

• Process Validation Lifecycle: The modern, three-stage approach is mandatory:

  1. Process Design: Documented understanding of the critical process parameters and critical quality attributes.

  2. Process Performance Qualification (PPQ): Execution of commercial-scale batches to confirm process consistency.

  3. Continued Process Verification (CPV): Ongoing monitoring to assure the process remains in a validated state throughout the product life cycle.

• Qualification: All critical equipment, utilities (e.g., Water Systems, HVAC, cleanrooms), and facilities must be fully Qualified (DQ, IQ, OQ, PQ). JAZMP's pharmaceutical inspectors issue the GMP Certificate based on the fulfilment of these conditions.

• Cleaning Validation: Acceptance criteria must be scientifically justified, typically based on a toxicological evaluation using Permitted Daily Exposure (PDE) limits, aligning with the Annex 15 requirements for shared facilities.

2. Quality Dossier Assessment (eCTD Module 3)

The Quality Module of the eCTD submission to JAZMP must be complete and accurate:

• Quality Assurance System: The MAA process, as well as the manufacturing authorization, requires a commitment from the applicant to manufacture medicinal products in accordance with GMP guidelines and an updated Quality Assurance System description.

• Analytical Method Validation (AMV): All methods used for quality control, including those for state quality control testing, must comply with ICH Q2(R1) principles, which ensure the reliability of the quality testing data.

3. JAZMP GMP Audits

JAZMP's Inspection Division conducts routine and targeted inspections, with the GMP Certificate typically valid for three years from the date of inspection.

• Audit Focus: Inspections focus on the robustness of the Pharmaceutical Quality System (PQS), the compliance of all processes with the Validation Master Plan (VMP), and the integrity of the data supporting validation (Data Integrity / CSV, often addressed under EU GMP Annex 11).

• Aseptic Compliance: For sterile manufacturers, inspections strictly verify adherence to the revised, highly prescriptive EU GMP Annex 1 (Manufacture of Sterile Medicinal Products).

🎯 Compliance Focus: Who We Support

We work with manufacturers targeting the Slovenian market:

• Aseptic/Sterile Manufacturers: Requiring specialized validation protocols for sterile products, aligned with the new, stricter EU GMP Annex 1.

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

• Local Slovenian Manufacturers: Seeking comprehensive VMPs and execution protocols to maintain the highest level of compliance for routine JAZMP inspections.

🛠️ Our Process Validation Services for JAZMP Compliance

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

ServiceJAZMP / 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 JAZMP's scientific quality assessment.

🤝 Next Step: Secure JAZMP Validation Readiness

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

To receive a Technical Scope and Commercial Proposal tailored for your Slovenia 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 JAZMP