🇨🇾 ValiPro: DPS (Cyprus) EU GMP Validation Services
Ensure Flawless Validation Documentation (eCTD Module 3) for DPS 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 Department of Pharmaceutical Services (DPS) for both local Cypriot manufacturers and foreign sites supplying the market.
Key compliance pillars for market access in Cyprus include:
National Authority (DPS/Drug Council): The Cypriot body responsible for scientific evaluation of efficacy, safety, and quality (CMC), granting Marketing Authorizations (MAA), and enforcing GMP through inspections.
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).
Dossier Submission: MAA must be submitted electronically via the Common European Submission Portal (CESP), using the eCTD format, with all validation data contained within Module 3 (Quality/CMC).
EU Procedures: Cyprus utilizes the National Procedure, the Mutual Recognition Procedure (MRP), and the Decentralised Procedure (DCP), all of which require a fully compliant EU GMP dossier.
🌟 Why Validation is Crucial for DPS Compliance
Validation is the core technical element of the Quality dossier (Module 3) that proves a product's consistent quality. The DPS relies on this evidence for both registration approval and ongoing site GMP compliance.
1. Mandatory Qualification and Validation (EU GMP Annex 15)
The DPS requires absolute adherence to the principles of EU GMP Annex 15 (Qualification and Validation):
Process Validation Lifecycle: The modern, three-stage approach is mandatory for all processes:
Process Design (Establishing process understanding).
Process Performance Qualification (PPQ) (Executing commercial-scale batches).
Continued Process Verification (CPV) (Ongoing monitoring).
Qualification: All critical equipment, systems, and utilities (such as HVAC, Water for Injection/Purified Water systems) must be fully Qualified (DQ, IQ, OQ, PQ) with documented evidence.
Cleaning Validation: Required to prevent cross-contamination in multi-product facilities. Acceptance limits must be scientifically justified, often based on Permitted Daily Exposure (PDE) limits, as per Annex 15 expectations.
2. Scientific Assessment of Quality (eCTD Module 3)
The DPS's Regulatory Sector pharmacists and assessors conduct a comprehensive scientific evaluation of the MAA dossier:
Manufacturing Process (3.2.P.3): This section must detail the complete manufacturing process and include a summary of the validation studies (PPQ reports/CPV plans) proving the process is robust and consistently yields a final product meeting specifications.
Analytical Method Validation (AMV): All quality control testing methods must be validated according to ICH Q2(R1) principles to ensure the reliability and accuracy of batch release and stability testing data.
3. DPS GMP Audits
The DPS is responsible for routine and targeted GMP inspections of pharmaceutical manufacturers in Cyprus. They also rely on the EU-wide system of GMP inspections (EudraGMDP database) for foreign sites supplying the Cypriot market.
Audit Focus: Inspections focus on the entire Pharmaceutical Quality System (PQS), ensuring the Validated State of the facility is maintained through robust Change Control and Deviation Management.
Brexit Impact: Due to its close ties and historical supply routes, Cyprus was granted temporary specific exemptions regarding the import and batch testing of medicines from the UK, underscoring the importance of maintaining documented GMP compliance and supply chain validation integrity.
🎯 Compliance Focus: Who We Support
We work with manufacturers targeting the Cypriot market:
Generic Drug Manufacturers: Requiring robust, internationally compliant Process Validation and Analytical Method Validation to support quality claims in the MAA (often for MRP/DCP submissions).
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 DPS/EU GMP requirements to support the MAA and the Qualified Person's (QP) batch release responsibility.
🛠️ Our Process Validation Services for DPS Compliance
We provide complete, scientifically sound, and EU-compliant validation documentation ready for DPS submission and audit defense.
ServiceDPS / 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 DPS's scientific quality assessment.
🤝 Next Step: Secure DPS Validation Readiness
Ensure your validation documentation is robust, aligns with the mandatory EU GMP and ICH guidelines, and is ready to support your Cypriot registration and GMP license application.
To receive a Technical Scope and Commercial Proposal tailored for your Cyprus 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 DPS