🇰🇿 ValiPro: EAEU GMP & eCTD Process Validation Services for Kazakhstan

Navigate the Unified EAEU Market via Kazakhstan with Validation Documentation Aligned to EAEU GMP and NCEM Requirements.

ValiPro provides expert Process Validation Protocol and Report services specifically designed for manufacturers targeting the market in Kazakhstan. Our documentation is built for full compliance with the rigorous standards enforced by the National Center for Expert Evaluation of Medicinal Products and Medical Devices (NCEM).

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

🌟 Why EAEU/Kazakhstan Validation is Crucial

Kazakhstan is fully implementing the EAEU regulations, which are designed to create a single pharmaceutical market, requiring the highest level of harmonization for quality and manufacturing data.

• EAEU GMP Mandate and Inspection: Compliance with EAEU GMP Rules (which are based on WHO/EU GMP) is mandatory. Foreign manufacturing sites must hold an EAEU GMP Certificate issued by an EAEU member state inspectorate (including Kazakhstan's). The inspection process focuses heavily on evidence of controlled processes, making your validation documentation a critical component of the audit defense.

• eCTD Submission Format: All initial registrations and renewals must now be submitted in the electronic EAEU CTD (eCTD) format. Your validation reports are a key part of Module 3 (Quality). The dossier must include detailed information on the production technology, control during the manufacturing process, and validation of manufacturing processes.

• Transition Deadline: Medicinal products registered under the older national legislation must be brought into compliance with the EAEU requirements by December 31, 2025. This transition requires a complete update of the dossier, including validation data, to the eCTD format.

• Analytical Examination: The NCEM conducts an analytical expert examination, which includes testing samples and determining the reproducibility of analytical procedures. Robust Analytical Validation documentation is essential to pass this stage.

🎯 Compliance Focus: Who We Support

We work with manufacturers targeting the Kazakhstani market via the EAEU procedures:

• EAEU Exporters: Targeting registration via the Mutual Recognition Procedure (MRP) or Decentralized Procedure (DCP), selecting Kazakhstan as the Reference Member State (RMS) or a Concerned Member State (CMS).

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

• EAEU GMP Audit Readiness: Foreign facilities preparing for an EAEU GMP inspection by a Kazakhstani or other EAEU inspectorate.

• CTD Module 3 Quality: Firms needing expert preparation of Module 3 to meet NCEM's rigorous quality assessment standards.

🛠️ Our Process Validation Services for Kazakhstan and EAEU

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

ServiceKazakhstan / EAEU GMP / eCTD FocusPVP & PVR PreparationCustom protocols and reports aligned with EAEU GMP Rules, specifically covering process and cleaning validation, demonstrating consistent quality.eCTD Module 3 IntegrationStructuring validation summaries and data precisely for the eCTD Module 3 (section 3.2.P.3.5) required by the NCEM/EAEU, including the mandatory Normative Document.Analytical Validation SupportPreparation of validation/verification reports for all control methods, ensuring compliance with the analytical examination and testing requirements.Transition Dossier SupportComprehensive gap analysis and remediation of older validation documentation to meet the EAEU CTD content requirements for the mandatory 2025 compliance deadline.

📜 Regulatory Standards We Follow

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

• 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.

• ICH Quality Principles: The underlying scientific foundation for the EAEU quality requirements.

🤝 Get Started on Your Kazakhstan Validation

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

To receive a Technical Scope and Commercial Proposal tailored for your Kazakhstani/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 NCEM/EAEU deficiency letters.