🇹🇿 ValiPro: TMDA, WHO GMP & EAC Process Validation Services

Achieve Compliance and Secure Product Registration in Tanzania with TMDA-Ready Validation Documentation.

ValiPro provides expert Process Validation Protocol and Report services tailored for manufacturers targeting the significant Tanzanian market. Our documentation is built for full compliance with the rigorous standards of the Tanzania Medicines and Medical Devices Authority (TMDA), the central regulatory authority, which strongly enforces WHO Good Manufacturing Practices (WHO GMP) Guidelines and mandates submissions in the East African Community (EAC) CTD format.

We specialize in supporting manufacturers of human and veterinary medicines, APIs, and medical devices, ensuring their validation packages secure timely TMDA approvals, minimize review deficiencies, and facilitate product registration across the EAC region.

🌟 Why TMDA-Ready Validation is Crucial

The TMDA is responsible for regulating all medicines and medical devices in Tanzania. Compliance with their standards is mandatory for market entry and is strictly aligned with international and regional best practices.

• WHO GMP Mandate: The TMDA enforces GMP standards that closely follow the WHO Technical Report Series (TRS). Your process validation documentation must conform precisely to these detailed international standards (e.g., WHO TRS Annex 3).

• EAC CTD Submission Format: Product registration dossiers must be submitted in the EAC Common Technical Document (CTD) format. We ensure your validation reports are correctly presented in Module 3 (Quality), aligning with the regional structure required by the TMDA.

• EAC Harmonization: Tanzania is a key member of the EAC. A robust validation dossier is crucial for successful collaborative assessment and market access across the entire East African Community.

• GMP Inspection: Foreign manufacturing sites must hold a valid GMP certificate recognized by the TMDA. Our strong, internationally-aligned validation documentation is essential evidence for demonstrating a state of control during the required assessment/inspection process.

🎯 TMDA Compliance Focus: Who We Support

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

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

• GMP Conformance: Overseas facilities seeking TMDA GMP Certification (based on WHO GMP) for importation permits.

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

• Regulatory Responses: Firms addressing technical deficiencies or quality queries issued by TMDA assessors, particularly those arising from EAC collaborative assessments.

🛠️ Our TMDA Process Validation Services

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

ServiceTMDA / WHO / EAC FocusPVP & PVR PreparationCustom protocols and reports aligned with WHO GMP (TRS) principles, detailing the process validation lifecycle (Design, Qualification, Continuous Verification).EAC CTD IntegrationStructuring validation summaries and data precisely for the EAC CTD Module 3 format required by the TMDA, ensuring easy review.GMP Gap AssessmentReviewing your current validation documents and procedures against the stringent WHO GMP standards adopted by the TMDA and the EAC.Technical Defense & Query HandlingProviding expert technical defense and drafting precise responses to TMDA assessors, crucial for navigating the technical review and collaborative assessment stages.

📜 Regulatory Standards We Follow

Our documentation is engineered to align with the core standards adopted and enforced by the Tanzania Medicines and Medical Devices Authority:

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

• EAC Common Technical Document (CTD) Guidelines: Compliance with the mandated regional dossier structure.

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

🤝 Get Started on Your TMDA Validation

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

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

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

• Target TMDA Status: Product Registration / GMP Compliance Check (New or Renewal)

• Manufacturing Process: Overview of critical steps and control strategy

• Timeline: Submission or inspection date

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