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🇨🇿 ValiPro: SÚKL (Czech Republic) EU GMP Validation Services

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

Key compliance pillars for market access in the Czech Republic include:

• National Authority (SÚKL): The Czech body responsible for granting Marketing Authorizations (MAA), manufacturer's licenses, and supervising the execution of GMP and GDP (Good Distribution Practice).

• 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, aligning with ICH Q8, Q9, and Q10 guidelines, and mandatory Qualification (IQ, OQ, PQ) of facilities and utilities, all centered on EU GMP Annex 15 (Qualification and Validation).

• Dossier Submission: Marketing Authorization Applications (MAA) must be submitted in the eCTD format via CESP, with validation data residing in Module 3 (Quality/CMC).

🌟 Why Validation is Crucial for SÚKL Compliance

SÚKL inspectors are highly trained and conduct thorough audits. Their inspection and assessment activities rely entirely on documented validation to ensure the manufacturing process is robust and the product is consistently safe and effective.

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

SÚKL inspectors strictly check for full adherence to the principles laid out in EU GMP Annex 15, which mandates a scientifically justified, lifecycle approach to quality assurance:

• Process Validation Lifecycle: The modern approach requires three stages. The new Annex 15 explicitly mentions the use of the Continuous Process Verification (CPV) and Hybrid Approach (a mix of traditional and continuous) alongside the Traditional Approach (three batches). Retrospective validation is no longer acceptable.

  1. Process Design

  2. Process Performance Qualification (PPQ)

  3. Continued Process Verification (CPV)

• Qualification: All critical utilities (e.g., Water for Injection, HVAC) and equipment must be fully Qualified (DQ, IQ, OQ, PQ). The Qualification documents can, where appropriate, incorporate vendor documentation (FAT/SAT).

• Cleaning Validation: The acceptance criteria for cleaning must be based on a toxicological evaluation using Permitted Daily Exposure (PDE) limits, as mandated by Annex 15, replacing older 10 ppm or 1/1000th dose criteria as the sole basis.

2. Marketing Authorization Submission (eCTD Module 3)

The eCTD submission to SÚKL must be technically compliant and scientifically sound to pass the assessment:

• Module 3 (Quality): The process validation summary, along with the results of Analytical Method Validation (AMV) (ICH Q2(R1)), must be provided to justify the proposed controls and testing methods.

• API Compliance: Active Pharmaceutical Ingredient (API) sourcing requires validation documentation (process and cleaning) that aligns with ICH Q7 (API GMP) principles, often reviewed via an Active Substance Master File (ASMF).

3. SÚKL GMP Audits

SÚKL conducts routine GMP inspections of Czech manufacturing sites and participates in the EU/EEA inspection system for foreign sites.

• Audit Focus: Inspections focus on the entire Pharmaceutical Quality System (PQS), with a major emphasis on the Validation Master Plan (VMP), executed protocols, and documentation control.

• US FDA Equivalence: Given SÚKL's recognition by the FDA, their inspection standards are internationally equivalent, meaning compliance prepares a site for audits by multiple major global authorities.

🎯 Compliance Focus: Who We Support

We work with manufacturers targeting the Czech market:

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

• Foreign Manufacturers (Importers): Needing validation dossiers that meet the stringent SÚKL/EU GMP requirements for the Marketing Authorization Application (MAA).

• Generic Drug Applicants: Providing robust Analytical Method Validation and Process Validation data to support the quality claims in the generic registration dossier.

🛠️ Our Process Validation Services for SÚKL Compliance

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

ServiceSÚKL / 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 SÚKL's scientific assessment.

🤝 Next Step: Secure SÚKL Validation Readiness

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

To receive a Technical Scope and Commercial Proposal tailored for your Czech Republic 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 SÚKL