🇸🇩 ValiPro: NMPB, WHO GMP & CTD Process Validation Services

Achieve Compliance and Secure Product Registration in Sudan with NMPB-Ready Validation Documentation.

ValiPro provides expert Process Validation Protocol and Report services tailored for manufacturers targeting the market in Sudan. Our documentation is built for full compliance with the rigorous standards of the National Medicines and Poisons Board (NMPB), the central regulatory authority, which strongly enforces WHO Good Manufacturing Practices (WHO GMP) Guidelines and mandates comprehensive documentation in the Common Technical Document (CTD) format.

We specialize in supporting manufacturers of human and veterinary medicines, APIs, and allied substances, ensuring their validation packages secure timely NMPB approvals, minimize deficiency letters, and support the mandatory facility registration process.

🌟 Why NMPB-Ready Validation is Crucial

The NMPB is responsible for ensuring the safety, efficacy, and quality of all regulated products in Sudan. Compliance is mandatory for market entry and ensuring public health safety.

• WHO GMP Mandate: The NMPB’s regulatory framework adopts and enforces WHO GMP guidelines. Your process validation documentation must conform precisely to these detailed international standards (e.g., WHO TRS Annex 3).

• CTD Submission Format: The NMPB requires the registration dossier, particularly for innovator and biological products, to be submitted in the Common Technical Document (CTD) format. Your validation reports are a critical component of Module 3 (Quality), specifically section 3.2.P.3.5 (Process Validation and/or Evaluation) and 3.2.P.3.3 (Description of Manufacturing Process and Process Controls).

• Detailed Manufacturing Data: The NMPB explicitly requires a detailed method of the manufacturing procedure, including a flow diagram, and documentation of In-Process Controls (IPC), critical steps, tests, and specifications. Robust validation reports are the required evidence that these processes are controlled.

• Analytical Validation: Validation of analytical procedures is required, particularly for non-pharmacopeial methods, and verification is required for official pharmacopeial methods (USP, BP, EP, etc.).

🎯 NMPB Compliance Focus: Who We Support

We work closely with manufacturers and their local agents in Sudan who need:

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

• Plant Registration: Overseas facilities seeking initial or renewed NMPB Plant Registration (requiring a valid GMP certificate and detailed manufacturing information).

• CTD Module 3 Quality: Preparation of the Quality Module ensuring that all manufacturing and control data, including process and cleaning validation, meets NMPB expectations.

• Regulatory Responses: Firms addressing technical deficiencies or quality queries issued by NMPB assessors regarding manufacturing process controls and capability.

🛠️ Our NMPB Process Validation Services

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

ServiceNMPB / WHO GMP / CTD FocusPVP & PVR PreparationCustom protocols and reports aligned with WHO GMP (TRS) principles, detailing the process validation lifecycle (Design, Qualification, Continuous Verification).CTD Module 3 IntegrationStructuring validation summaries and data precisely for the CTD Module 3 format required by the NMPB, including detailed manufacturing descriptions and IPCs.Analytical Validation SupportPreparation of analytical validation protocols and reports for methods used to test drug substance and drug product, as required for section 3.2.P.5.3.GMP Gap AssessmentReviewing your current validation documents and procedures against the stringent WHO GMP standards adopted by the NMPB.

📜 Regulatory Standards We Follow

Our documentation is engineered to align with the core standards adopted and enforced by the National Medicines and Poisons Board:

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

• CTD (Common Technical Document): Compliance with the mandated dossier structure, particularly Modules 2 and 3.

• ICH Q8, Q9, Q10: Alignment with these global principles to support a modern, risk-based approach to validation.

• WHO Climatic Zone IV A: Validation of stability studies must meet the requirements for this zone, which Sudan falls under.

🤝 Get Started on Your NMPB Validation

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

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

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

• Target NMPB Status: Product Registration / Plant Registration Renewal

• Manufacturing Process: Overview of critical steps and control strategy

• Timeline: Submission or inspection date

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