🇺🇿 ValiPro: State Center, GMP & CTD Process Validation Services for Uzbekistan

Achieve Compliance and Secure Product Registration in Uzbekistan by Meeting the State Center's CTD Quality and Mandatory GMP Standards.

ValiPro provides expert Process Validation Protocol and Report services specifically designed for manufacturers targeting the Uzbekistan market. Our documentation is built for full compliance with the rigorous standards enforced by the State Center for Pharmaceutical Products Safety.

Key compliance pillars include:

• Mandatory submission of a GMP Certificate from the manufacturing site.

• The registration dossier is submitted in a National Format based on the Common Technical Document (CTD) structure.

• Validation data must support the required Laboratory Testing of product samples.

🌟 Why Uzbekistan/CTD Validation is Crucial

Uzbekistan has implemented significant regulatory reforms to accelerate its pharmaceutical industry, emphasizing quality and international harmonization.

• CTD-Based Dossier: Uzbekistan requires the submission of a dossier containing four modules drawn up based on the CTD format. Specifically, the section on Manufacture of Active Substance(s) requires "Description of manufacturing process and process control" and "Process validation and/or evaluation" (3.2.S.2.5). The Finished Product section similarly requires detailed manufacturing process and control data.

• Mandatory GMP Compliance (2026): All pharmaceutical manufacturers (domestic and foreign) will be required to obtain a national GMP certificate to register or renew their products from January 1, 2026. This mandates robust validation documentation aligned with international standards (often WHO/EU GMP) to pass the required GMP compliance proof or inspection.

• Laboratory Analysis: The registration procedure includes a mandatory stage of Laboratory Testing of the finished product samples. This requires submissions to include Analytical Procedures and Validation of Analytical Procedures (3.2.S.4.2 & 3.2.S.4.3), ensuring the methods can be reproduced and verified by the State Center.

• Registration Certificate Validity: The registration certificate is valid for 5 years and renewal requires a full dossier review, including updated quality and stability data.

🎯 Compliance Focus: Who We Support

We work with international manufacturers targeting the Uzbekistan market:

• Pharmaceutical Exporters: Targeting human and veterinary drug registration with the State Center.

• GMP Readiness: Foreign facilities preparing for the mandatory GMP compliance proof required for registration/renewal from 2026.

• CTD Quality Module: Firms needing expert preparation of the quality sections (Module 3 equivalent), ensuring all technical information, especially validation data, is complete and correctly structured.

• Analytical Validation: Companies needing robust Analytical Method Validation (AMV) reports to support the local quality control testing phase.

🛠️ Our Process Validation Services for Uzbekistan

We provide complete, scientifically sound, and document-intensive support tailored to the content requirements of the CTD-based National Dossier.

ServiceUzbekistan / GMP / CTD FocusPVP & PVR PreparationCustom protocols and reports aligned with WHO/EU GMP principles, providing the required content for CTD sections on process control and validation (3.2.P.3.5 and 3.2.S.2.5).CTD Quality IntegrationStructuring and summarizing validation data into the CTD (Module 3 equivalent) national format, ensuring clarity for the expert evaluation by the State Center.Analytical Validation SupportPreparation of AMV reports for all quality control methods, crucial for passing the mandatory Laboratory Testing phase of registration.GMP Audit Defense SupportReviewing validation data against known international standards to ensure the manufacturing site can successfully provide proof of or be inspected for GMP compliance post-2025.

📜 Regulatory Standards We Follow

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

• CTD (Common Technical Document): The required structure and content for the registration dossier.

• WHO/EU GMP: The international benchmark for manufacturing practice compliance that underpins the national GMP requirements.

• ICH Quality Principles (Q8, Q9, Q10): The scientific foundation for the required validation data.

🤝 Get Started on Your Uzbekistan Validation

Ensure your process validation documentation is robust, correctly formatted, and immediately acceptable to the State Center, securing your necessary approvals and market access in Uzbekistan.

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

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

• Target Status: New Registration / Renewal

• Manufacturing Process: Overview of critical steps and control strategy

• Timeline: Submission or inspection date

• Existing Data: Any current validation documents or State Center deficiency letters.