🇹🇲 ValiPro: Center for Registration & WHO GMP Validation Services

Ensure Product Registration in Turkmenistan with Validation Documentation Aligned to National Requirements and International Quality Standards.

ValiPro provides expert Process Validation Protocol and Report services tailored for manufacturers targeting the Turkmenistani market. Our documentation is built for full compliance with the standards enforced by the Ministry of Health and Medical Industry.

Key compliance pillars include mandatory provision of a GMP Certificate (often WHO-GMP or SRA-compliant), submission of a comprehensive National Dossier, and supporting evidence for the laboratory analysis of samples.

🌟 Why Turkmenistan Validation is Crucial

Registration is mandatory before any medicine can be imported or sold. The process is thorough, emphasizing the proven quality and reproducibility of the product's manufacturing process.

• Mandatory GMP Certificate: The registration dossier must include a legalized GMP Certificate (or its copy) and a Certificate of Pharmaceutical Product (CPP). This certificate is validated by the Ministry, which reserves the right to perform a manufacturing facility inspection (though it is not routine). Robust process validation reports are essential technical proof of compliance that underpins the GMP certificate.

• National Dossier Format: The registration dossier is provided in a National Format according to an approved list of documents. The CTD format is generally not accepted unless prior approval is obtained. The dossier must contain a detailed description of the manufacturing technology, specifications, and control methods for both the finished product and the API.

• Language Requirement: Documentation, including labeling and instructions for use, should be submitted in Turkmen, and/or Russian, and/or English. Technical summaries of the validation data are typically best presented in English or Russian for the expert review.

• Laboratory Analysis: The registration process includes a mandatory Laboratory Analysis of the quality of samples of the product, requiring robust Analytical Validation documentation and the submission of reference standards.

🎯 Compliance Focus: Who We Support

We work closely with manufacturers targeting the Turkmenistan market:

• Pharmaceutical Exporters: Targeting state registration or renewal with the Ministry of Health and its Registration Center.

• GMP/Quality Proof: Overseas facilities needing validation documentation that unequivocally supports their international GMP Certificate during the Ministry's expert evaluation.

• National Dossier Quality: Preparation of the quality sections (manufacturing and control) to meet the Center's technical expectations for the specific national format.

• Analytical Reproducibility: Firms requiring Analytical Method Validation (AMV) reports that can be used by the local control laboratory to verify the quality control methods.

🛠️ Our Process Validation Services for Turkmenistan

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

ServiceTurkmenistan / National Dossier FocusPVP & PVR PreparationCustom protocols and reports aligned with WHO GMP principles, detailing the process validation lifecycle and providing the necessary technical description for the national dossier.National Dossier SummarizationStructuring the validation summary, batch records, and control data to fit the requirements of the National Dossier, focusing on clarity for the expert review.Analytical Validation SupportPreparation of AMV reports for all analytical methods used to control the drug substance and drug product, ensuring compliance for the required laboratory analysis.GMP/CPP SupportReviewing and supplementing validation documentation to ensure it fully supports the foreign manufacturer's GMP Certificate and CPP required for submission.

📜 Regulatory Standards We Follow

Our documentation is engineered to align with the core standards adopted and enforced by the Ministry of Health and Medical Industry:

• Law of Turkmenistan “On Drug Provision” (2016): The primary national legislation governing registration and pharmaceutical activities.

• WHO GMP Guidelines: The underlying international benchmark for manufacturing practice compliance.

• ICH Quality Principles: Providing the scientific foundation for robust validation (e.g., ICH Q2 for Analytical Validation).

🤝 Get Started on Your Turkmenistan Validation

Ensure your process validation documentation is robust, appropriately formatted, and immediately acceptable to the Ministry of Health, securing your necessary approvals and market access in Turkmenistan.

To receive a Technical Scope and Commercial Proposal tailored for your Turkmenistani 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 Ministry deficiency letters.