🇧🇾 ValiPro: EAEU GMP & CTD Process Validation Services for Belarus

Navigate the Belarusian and EAEU Regulatory Landscape with Validation Documentation Aligned to RCETH and EAEU GMP Standards.

ValiPro provides expert Process Validation Protocol and Report services specifically designed for manufacturers targeting the market in Belarus. Our documentation is built for full compliance with the rigorous standards enforced by the Center for Expert Evaluation and Testing in Healthcare (RCETH), which operates under the Ministry of Health.

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

🌟 Why Validation is Critical for Registration in Belarus

Belarusian regulatory control is dual-layered, operating under both national and EAEU procedures, with high standards for product quality and manufacturing site compliance.

• EAEU GMP Mandate & Inspection: The most critical requirement is compliance with the EAEU GMP Rules. Foreign manufacturing sites must often undergo a GMP inspection by the Belarusian Pharmaceutical Inspectorate (or receive an EAEU GMP certificate via a work-sharing arrangement). Non-conformities related to Process Validation are frequently cited findings in these inspections.

• CTD Submission Format: The registration dossier must be submitted in the CTD format (which replaced the older national format). We ensure your Process Validation reports, summaries, and data are correctly structured for Module 3 (Quality), which undergoes specialized expertise by the RCETH.

• Simplified Registration (SRA Reliance): Belarus offers a simplified registration route for products registered by recognized high-standard regulatory authorities (SRAs) like the EMA, FDA, etc. Even in this route, the submission requires a comprehensive dossier and proof of GMP compliance.

• API and Finished Product Validation: Validation documentation for both Finished Medicinal Products and Active Pharmaceutical Ingredients (APIs) is required for state registration. For APIs, the requirements include manufacturing schedules, specifications, and validation of control methods.

🎯 Compliance Focus: Who We Support

We work with manufacturers targeting the Belarusian market via either the National or the EAEU registration procedure:

• Pharmaceutical Exporters: Targeting state registration or renewal in Belarus, or registration via the unified EAEU procedure.

• GMP Inspection Readiness: Foreign facilities preparing for an EAEU GMP inspection by the Belarusian Pharmaceutical Inspectorate.

• CTD Module 3 Quality: Firms needing expert preparation of Module 3 to meet RCETH's exacting standards.

• Dossier Harmonization: Companies bringing their existing national dossiers into compliance with the EAEU CTD format.

🛠️ Our Process Validation Services for Belarus and EAEU

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

ServiceBelarus / EAEU GMP / CTD FocusPVP & PVR PreparationCustom protocols and reports aligned with the EAEU GMP Rules (based on WHO/EU GMP), specifically focusing on Section 5 (Premises and Equipment) and Section 9 (Quality Control).CTD Module 3 IntegrationStructuring validation data precisely for the CTD Module 3 (section 3.2.P.3.5, Process Validation) required by the RCETH/EAEU.Analytical Validation & ApprobationPreparation of validation/verification reports for all control methods, supporting the required approbation of quality control methods by the Center.GMP Deficiency ResponseExpert technical support to address and close non-conformities related to Process Validation, Qualification of Equipment and Auxiliary Systems, which are frequently observed by inspectors.

📜 Regulatory Standards We Follow

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

• EAEU GMP Rules: The primary benchmark for manufacturing practice compliance (adopted in 2016).

• CTD (Common Technical Document): The mandatory structure for all registration dossiers.

• WHO GMP (Technical Report Series): The foundational global standard that underpins EAEU GMP.

🤝 Get Started on Your Belarusian Validation

Ensure your process validation documentation is robust and immediately acceptable to the RCETH and the EAEU inspectorate, securing your necessary approvals and market access in Belarus.

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

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

• Target Status: National Registration / EAEU Unified Registration / GMP Inspection Application

• Manufacturing Process: Overview of critical steps and control strategy

• Timeline: Submission or inspection date

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