🇸🇰 ValiPro: ŠÚKL (Slovakia) EU GMP Validation Services

Ensure Flawless Validation Documentation (Module 3) for ŠÚKL 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 ŠÚKL for both local Slovakian manufacturers and foreign sites supplying the market.

Key compliance pillars for market access in Slovakia include:

• National Authority (ŠÚKL): The Slovak body responsible for granting marketing authorizations, conducting inspections, and enforcing compliance with the national law on medicinal products, which incorporates all EU directives and regulations.

• Manufacturing Standard (EU GMP): Compliance with the EU Guidelines to Good Manufacturing Practice (2010 Revision), which includes the PIC/S Guide to GMP.

• Validation Requirements: Strict adherence to EU GMP Annex 15 (Qualification and Validation), which is the cornerstone for all validation activities in Slovakia.

• Dossier Submission: Marketing Authorization Applications (MAA) must be submitted in the Common Technical Document (CTD) format, with validation data contained in Module 3 (Quality/CMC).

🌟 Why Validation is Crucial for ŠÚKL Compliance

Validation is the documented evidence that a manufacturer's process is reliably controlled, ensuring product quality. This is the primary focus of both the ŠÚKL registration review and their GMP inspection activities.

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

ŠÚKL inspectors check for full adherence to the principles laid out in EU GMP Annex 15, which mandates a lifecycle, risk-based approach to validation.

• Qualification Lifecycle: All critical equipment and utilities must be fully Qualified through the four stages: Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

• Process Validation Lifecycle: Critical manufacturing processes must be validated using a lifecycle approach: Process Design, Process Performance Qualification (PPQ), and Continued Process Verification (CPV).

• Cleaning Validation: Validation of cleaning procedures is mandatory, with acceptance criteria based on a toxicological evaluation (PDE/ADE limits), not just historical limits like 10 ppm, as required by Annex 15.

2. Marketing Authorization Submission (CTD Module 3)

The Quality Module (Module 3) of the registration dossier must contain validation data that is technically rigorous to satisfy the ŠÚKL assessors:

• Analytical Method Validation (AMV): All in-house analytical testing methods 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, including process and cleaning validation.

• Language: While the dossier may be submitted in English, all submitted information, including validation summaries, must be consistent with the proposed product information.

3. ŠÚKL GMP Audits

ŠÚKL conducts routine and pre-licensing GMP inspections on domestic sites and cooperates with other EU authorities to inspect foreign sites supplying the EU market.

• Audit Focus: Inspections focus on the Pharmaceutical Quality System (PQS) and verifying that the entire facility, equipment, and processes are operating in their validated state.

• PIC/S Alignment: As a member of PIC/S, ŠÚKL follows globally recognized inspection standards. Auditors use the PIC/S inspection guides and check the Validation Master Plan (VMP) as the roadmap for the site's quality assurance strategy.

🎯 Compliance Focus: Who We Support

We work with manufacturers targeting the Slovakian market:

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

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

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

🛠️ Our Process Validation Services for ŠÚKL Compliance

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

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

🤝 Next Step: Secure ŠÚKL Validation Readiness

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

To receive a Technical Scope and Commercial Proposal tailored for your Slovakia 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 ŠÚKL