🇾🇪 ValiPro: SBDMA & WHO GMP Process Validation Services

Achieve Compliance and Secure Drug Registration with Yemen's Supreme Board of Drugs and Medical Appliances (SBDMA).

ValiPro provides expert Process Validation Protocol and Report services tailored for manufacturers targeting the Yemeni market. Our documentation is built for full compliance with the requirements of the Supreme Board of Drugs and Medical Appliances (SBDMA), which strictly adheres to WHO Good Manufacturing Practices (GMP) Guidelines and other recognized international standards.

We specialize in supporting manufacturers of human medicines, veterinary medicines, and medical supplies, ensuring their validation packages secure timely SBDMA approvals, minimize review deficiencies, and facilitate product registration in Yemen.

🌟 Why SBDMA-Ready Validation is Crucial

The SBDMA is the central authority responsible for regulating drugs and medical appliances in Yemen. Meeting their standards is mandatory for market entry.

• WHO GMP Reliance: The SBDMA's regulatory framework primarily adopts and enforces WHO GMP guidelines. This means your validation documentation must align with WHO's expectations for quality systems and process control (e.g., WHO TRS Annex 3).

• Dossier Requirement: Product registration in Yemen requires a comprehensive dossier submission. Validation reports for critical manufacturing and cleaning processes form a crucial part of the Quality Module reviewed by the SBDMA.

• Certificate of Free Sale (CFS) Prerequisite: Foreign manufacturers must provide documents demonstrating GMP compliance and product quality, for which robust process validation reports are essential evidence.

🎯 SBDMA Compliance Focus: Who We Support

We work closely with manufacturers and their local agents in Yemen who need compliance with the following:

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

• GMP Conformance: Manufacturers requiring documented evidence of WHO GMP conformance for their entire manufacturing, cleaning, and analytical validation systems.

• Product Dossier Quality: Preparation of the Quality Module ensuring that all manufacturing and control data, including validation, meets SBDMA expectations.

• Regulatory Responses: Firms addressing deficiency letters or quality queries issued by SBDMA assessors regarding manufacturing process controls and capability.

🛠️ Our SBDMA Process Validation Services

We provide complete, scientifically sound, and document-intensive support to meet the SBDMA's expectations for quality data and process control.

ServiceSBDMA / WHO FocusPVP & PVR PreparationCustom protocols and reports structured to address WHO GMP (TRS) validation principles, including the demonstration of process capability and robustness.Analytical ValidationPreparation of detailed Analytical Method Validation Reports to ensure testing procedures meet international and local standards for quality control.Dossier IntegrationStructuring validation data to be easily incorporated into the SBDMA's required submission format for the Quality Module.Gap AssessmentReviewing current validation procedures against the adopted WHO GMP and any specific SBDMA regulatory circulars.Query HandlingProviding expert technical defense and drafting responses to quality and validation queries from SBDMA assessors.

📜 Regulatory Standards We Follow

Our documentation is engineered to align with the core standards prioritized by the SBDMA:

• WHO Technical Report Series (TRS): The foundational benchmark for GMP and validation compliance in Yemen.

• ICH Q8, Q9, Q10: Alignment with these global principles ensures that the process lifecycle approach is acceptable, demonstrating a modern, risk-based approach to validation.

• US FDA / EU GMP: Used as reference standards for advanced technical depth and robustness, which aids in gaining SBDMA regulatory confidence.

• GCC (Gulf Cooperation Council) Standards: Relevant for companies that also market in neighboring GCC countries, ensuring a broad regional compliance strategy.

🤝 Get Started on Your SBDMA Validation

Ensure your process validation documentation is robust and immediately acceptable to the SBDMA, securing your necessary approvals and market access in Yemen.

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

• Product: Dosage form (e.g., tablet, injectable) and Batch Size

• Target SBDMA Category: (e.g., Human Drug, Veterinary Drug, Medical Supply)

• Target Status: New Registration / Renewal / GMP Compliance Check

• Timeline: Submission or inspection date

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