🇿🇲 ValiPro: ZAMRA, WHO GMP & ZAZIBONA Process Validation Services

Achieve Compliance and Secure Product Registration in Zambia with ZAMRA-Ready Validation Documentation.

ValiPro provides expert Process Validation Protocol and Report services tailored for manufacturers targeting the Zambian market. Our documentation is built for full compliance with the rigorous standards of the Zambia Medicines and Medical Devices Agency (ZAMRA), the central regulatory authority, which strongly enforces WHO Good Manufacturing Practices (WHO GMP) Guidelines and mandates submissions in the Common Technical Document (CTD) format.

We specialize in supporting manufacturers of human and veterinary medicines, APIs, and medical devices, ensuring their validation packages secure timely ZAMRA approvals, minimize review deficiencies, and support successful participation in the ZAZIBONA collaborative assessment procedure.

🌟 Why ZAMRA-Ready Validation is Crucial

ZAMRA is responsible for the regulation and control of medicines and medical devices in Zambia. Compliance with their standards is mandatory for market entry and is strictly aligned with international best practices and regional agreements.

• WHO GMP Mandate: ZAMRA’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: Product registration dossiers must be submitted in the Common Technical Document (CTD) format. We ensure your validation reports are correctly presented in Module 3 (Quality), aligning with the regional structure required.

• ZAZIBONA and SADC Alignment: Zambia is a key participant in the ZAZIBONA regulatory reliance network. A robust validation dossier is crucial for successful collaborative assessment and market access across the Southern African Development Community (SADC) region.

• GMP Inspection: Foreign manufacturing sites must hold a valid GMP certificate recognized by ZAMRA, often involving an inspection or reliance on recognized SRA (Stringent Regulatory Authority) reports. Our strong validation reports are key evidence of the manufacturing site's state of control.

🎯 ZAMRA Compliance Focus: Who We Support

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

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

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

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

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

🛠️ Our ZAMRA Process Validation Services

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

ServiceZAMRA / WHO / ZAZIBONA 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 ZAMRA, ensuring easy review.GMP Gap AssessmentReviewing your current validation documents and procedures against the stringent WHO GMP standards adopted by ZAMRA and ZAZIBONA.Technical Defense & Query HandlingProviding expert technical defense and drafting precise responses to ZAMRA assessors, crucial for navigating the ZAZIBONA assessment process.

📜 Regulatory Standards We Follow

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

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

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

• ZAZIBONA / SADC Guidelines: Awareness of regional requirements and collaborative assessment principles.

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

🤝 Get Started on Your ZAMRA Validation

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

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

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

• Target ZAMRA 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 ZAMRA deficiency letters.