🇵🇱 ValiPro: URPL (Poland) EU GMP Validation Services
Ensure Flawless Validation Documentation (Module 3) for URPL Registration and Pass Mandatory GIF Inspections 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 Polish authorities for both local manufacturers and foreign sites supplying the Polish market.
Key compliance pillars for market access in Poland include:
National Authority (URPL): The Polish body responsible for granting marketing authorizations for medicinal products via national, decentralized (DCP), or mutual recognition (MRP) procedures, based on assessment of quality, safety, and efficacy.
Enforcement (GIF): The Chief Pharmaceutical Inspectorate (GIF) is the enforcement arm that conducts routine and pre-licensing GMP inspections on manufacturing sites.
Manufacturing Standard (EU GMP): Compliance with the EU Guidelines to Good Manufacturing Practice and the PIC/S Guide to GMP, making Annex 15 (Qualification and Validation) the core regulatory standard.
Validation Focus: Validation documentation is essential for the quality module (Module 3) of the registration dossier and for successfully passing GIF's GMP audits.
🌟 Why Validation is Crucial for URPL and GIF Compliance
Compliance with validation requirements is the most direct way for manufacturers to demonstrate process control and product quality consistency, which are non-negotiable for the EU market.
1. Mandatory Qualification and Validation (EU GMP Annex 15)
The Polish pharmaceutical law fully incorporates the EU GMP, making Annex 15 the standard for all validation activities. This mandates a lifecycle approach to quality assurance:
Qualification Lifecycle: 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: The validation of critical processes (e.g., mixing, drying, compression, sterilization) must follow the lifecycle model: Process Design, Process Performance Qualification (PPQ), and Continued Process Verification (CPV).
Quality Risk Management (QRM): The scope and extent of validation activities must be based on a documented risk assessment, adhering to ICH Q9 principles.
2. Marketing Authorization Submission (CTD Module 3)
The Quality Module (Module 3) of the CTD dossier submitted to URPL must contain validation data that is scientifically sound and audit-ready:
Analytical Method Validation (AMV): All in-house analytical testing methods must be validated according to ICH Q2(R1) to ensure reliable quality control results, aligning with the European Pharmacopoeia (which is fully aligned with the Polish Pharmacopoeia).
API Validation: Manufacturing of Active Pharmaceutical Ingredients (APIs) must be validated according to ICH Q7 (API GMP), including rigorous Cleaning Validation to manage cross-contamination risk.
Computer System Validation (CSV): Any computerized system impacting GMP data (e.g., LIMS, ERP, QC instruments) must be validated according to EU GMP Annex 11.
3. Chief Pharmaceutical Inspectorate (GIF) Audits
The GIF inspection focuses on practical implementation of the Quality Management System (QMS), with validation files serving as the primary evidence.
Audit Focus: GIF auditors check the Validation Master Plan (VMP), the execution of protocols (checking for deviations), and the completeness of final validation reports. They verify that the facility operates according to the validated state.
Compliance Verification: GIF is the local body responsible for verifying compliance with EU GMP for granting or renewing manufacturing and import licenses.
🎯 Compliance Focus: Who We Support
We work with manufacturers targeting the Polish market:
Foreign Manufacturers (Importers): Requiring validation dossiers that meet the stringent URPL/EU GMP requirements for the Marketing Authorization Application (MAA).
Local Polish Manufacturers: Needing comprehensive VMPs and execution of Qualification/Validation protocols to pass routine GIF inspections.
EU Generic Drug Applicants: Providing robust Analytical Method Validation and Process Validation data to support the quality claims in the generic (ANDA) registration dossier.
🛠️ Our Process Validation Services for URPL/GIF Compliance
We provide complete, scientifically sound, and EU-compliant validation documentation ready for URPL submission and GIF audit defense.
ServiceURPL / 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.CTD Module 3 Technical SupportStructuring and organizing validation summaries and data for inclusion in the CTD Module 3 to pass the URPL's scientific assessment.
🤝 Next Step: Secure URPL Validation Readiness
Ensure your validation documentation is robust, aligns with the mandatory EU GMP and ICH guidelines, and is ready to support your Polish registration and GMP license application.
To receive a Technical Scope and Commercial Proposal tailored for your Poland 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 URPL