🇳🇬 ValiPro: NAFDAC, WHO GMP & PIC/S Process Validation Services

Achieve Swift Approval and Market Access in Nigeria with NAFDAC-Ready Validation Documentation.

ValiPro provides expert Process Validation Protocol and Report services tailored for manufacturers targeting the massive Nigerian market. Our documentation is built for full compliance with the rigorous standards of the National Agency for Food and Drug Administration and Control (NAFDAC), the central regulatory body, which strongly adheres to WHO Good Manufacturing Practices (WHO GMP) Guidelines and aligns with PIC/S principles.

We specialize in supporting manufacturers of human and veterinary medicines, APIs, food supplements, and medical devices, ensuring their validation packages secure timely NAFDAC approvals, minimize deficiency letters, and support the mandatory GMP inspection process for foreign sites.

🌟 Why NAFDAC-Ready Validation is Crucial

NAFDAC regulates all aspects of manufacturing, importation, exportation, and sale of regulated products in Nigeria. Compliance with their standards is mandatory for market entry.

• WHO/PIC/S GMP Mandate: NAFDAC enforces GMP standards that closely follow the WHO Technical Report Series (TRS) and is increasingly aligned with PIC/S principles. Your process validation documentation must conform precisely to these detailed international standards.

• CTD Submission Format: Product registration dossiers must follow a format compatible with the Common Technical Document (CTD) structure. We ensure your validation reports are correctly presented in the Quality Module (Module 3).

• GMP Inspection & Vetting: Foreign manufacturing sites must undergo NAFDAC GMP Inspection and Vetting before product registration can be granted. Our robust, internationally-aligned validation documentation is essential evidence for demonstrating a state of control during the inspection process.

• Product Renewal: Validation data is routinely reviewed during product license renewal processes.

🎯 NAFDAC Compliance Focus: Who We Support

We work closely with manufacturers and their local representatives in Nigeria who need:

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

• GMP Conformance: Overseas facilities seeking NAFDAC GMP Vetting and Certification (based on WHO/PIC/S GMP).

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

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

🛠️ Our NAFDAC Process Validation Services

We provide complete, scientifically sound, and document-intensive support to meet NAFDAC's expectations for WHO/PIC/S-aligned quality data.

ServiceNAFDAC / WHO / PIC/S FocusPVP & PVR PreparationCustom protocols and reports aligned with WHO GMP (TRS) / PIC/S principles, detailing the process validation lifecycle (Design, Qualification, Continuous Verification).Dossier IntegrationStructuring validation summaries and data precisely for the CTD format (Quality Module) required by NAFDAC.GMP Gap AssessmentReviewing your current validation documents and procedures against the stringent WHO GMP and PIC/S standards adopted by NAFDAC.Technical Defense & Query HandlingProviding expert technical defense and drafting precise responses to NAFDAC assessors, crucial for passing the technical vetting and inspection stages.

📜 Regulatory Standards We Follow

Our documentation is engineered to align with the core standards adopted and enforced by NAFDAC:

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

• PIC/S GMP Guide: Principles and annexes are heavily relied upon for facility quality and control.

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

• ECOWAS/WAHO: Compliance is structured to support regional harmonization efforts.

🤝 Get Started on Your NAFDAC Validation

Ensure your process validation documentation is robust and immediately acceptable to NAFDAC, securing your necessary approvals and market access in Nigeria.

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

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

• Target NAFDAC Status: Product Registration / GMP Inspection & Vetting (New or Renewal)

• Manufacturing Process: Overview of critical steps and control strategy

• Timeline: Submission or inspection date

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