🇷🇺 ValiPro: EAEU GMP & eCTD Process Validation Services for Russia

Ensure Unhindered Market Access in Russia with Validation Documentation Aligned to EAEU GMP, Minzdrav, and SCEMP Standards.

ValiPro provides expert Process Validation Protocol and Report services specifically designed for manufacturers targeting the Russian Federation. Our documentation is built for full compliance with the rigorous standards enforced by Minzdrav, which requires adherence to the unified rules of the EAEU.

Key compliance pillars include mandatory adherence to EAEU Good Manufacturing Practice (EAEU GMP) Rules and the submission of the registration dossier in the EAEU Common Technical Document (eCTD) format.

🌟 Why EAEU/Russian Validation is Crucial

Russia's pharmaceutical market is now primarily governed by the EAEU framework, demanding strict adherence to unified international quality and manufacturing standards.

• EAEU GMP Mandate and Inspection: Compliance with EAEU GMP Rules is mandatory for all foreign manufacturers. The Russian Ministry of Industry and Trade (Minpromtorg) conducts GMP inspections (via the FSI SID&GP) for foreign sites seeking a Russian/EAEU GMP Certificate. Robust validation reports are critical evidence of the facility's state of control and process capability required to pass this audit.

• eCTD Submission Format: All new drug registrations and products transitioning from the old national procedure must be submitted in the electronic EAEU CTD (eCTD) format. Process Validation reports, summaries, and data must be correctly integrated into Module 3 (Quality) (specifically section 3.2.P.3.5) and summarized in Russian.

• 2025 Compliance Deadline: The deadline of December 31, 2025, requires all medicinal products previously registered under national rules to be brought into compliance with the EAEU eCTD requirements. This mandates a complete gap analysis and update of all validation documentation.

• Normative Document (ND): The registration process requires the development of a mandatory Normative Document (ND) (a set of quality control methods and specifications) which must be supported by validated analytical and manufacturing procedures.

🎯 Compliance Focus: Who We Support

We work with international manufacturers targeting the Russian market via the EAEU procedures:

• EAEU Exporters: Targeting registration via the EAEU unified procedures, using Russia as the Reference Member State (RMS) or a Concerned Member State (CMS).

• Dossier Transition: Companies needing to update their existing national registration dossiers into the required EAEU eCTD format before the 2025 deadline.

• Russian GMP Audit Readiness: Foreign facilities preparing for an EAEU GMP inspection by the Russian Ministry of Industry and Trade (Minpromtorg).

• CTD Module 3 Quality: Firms needing expert preparation of Module 3 documentation, ensuring all submissions are complete, in the correct format, and professionally translated into Russian.

🛠️ Our Process Validation Services for Russia and EAEU

We provide complete, scientifically sound, and document-intensive support to meet the SCEMP's and the inspectorate's expectations for EAEU-aligned quality data.

ServiceRussia / EAEU GMP / eCTD FocusPVP & PVR PreparationCustom protocols and reports aligned with EAEU GMP Rules, specifically covering process, cleaning, and utility validation, which are key inspection focus areas.eCTD Module 3 IntegrationStructuring and drafting validation summaries and data precisely for the eCTD Module 3 (section 3.2.P.3.5) and ensuring accurate Russian translation of all key summaries.Normative Document SupportProviding documentation that directly supports the quality control method descriptions and specifications outlined in the mandatory Normative Document (ND).GMP Pre-Audit & CAPA SupportReviewing validation data against known Russian and EAEU inspection findings (e.g., specific compendial tests, Data Integrity) and supporting the development of Corrective Action/Preventive Action (CAPA) plans.

📜 Regulatory Standards We Follow

Our documentation is engineered to align with the core standards adopted and enforced in Russia:

• EAEU GMP Rules (Decision No. 78): The mandatory benchmark for manufacturing practice compliance.

• EAEU CTD / eCTD: The required structure and format for all registration dossiers.

• Federal Law No. 61-FZ: The legislative foundation for drug circulation in the Russian Federation.

🤝 Get Started on Your Russian Validation

Ensure your process validation documentation is robust and immediately acceptable to the Ministry of Health and the EAEU inspectorate, securing your necessary approvals and market access in Russia.

To receive a Technical Scope and Commercial Proposal tailored for your Russian/EAEU project, simply provide:

• Product: Dosage form (e.g., solid oral, injectable, API) and Batch Size

• Target Status: EAEU Unified Registration / Transition to EAEU CTD / GMP Inspection

• Manufacturing Process: Overview of critical steps and control strategy

• Timeline: Submission or inspection date

• Existing Data: Any current validation documents or Minzdrav/EAEU deficiency letters.