🇲🇼 ValiPro: PMRA, WHO GMP & ZAZIBONA Process Validation Services

Achieve Compliance and Secure Product Registration in Malawi with PMRA-Ready Validation Documentation.

ValiPro provides expert Process Validation Protocol and Report services tailored for manufacturers targeting the market in Malawi. Our documentation is built for full compliance with the rigorous standards of the Pharmacy and Medicines Regulatory Authority (PMRA), 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 allied substances, ensuring their validation packages secure timely PMRA approvals, minimize review deficiencies, and support successful participation in the ZAZIBONA collaborative assessment procedure.

🌟 Why PMRA-Ready Validation is Crucial

The PMRA is the statutory organization responsible for regulating all medicines and allied substances in Malawi. Meeting their standards is mandatory for market entry and ensuring public health safety.

• WHO GMP Mandate: The PMRA's regulatory framework and inspection guidelines adopt and enforce 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 (ICH M4Q or WHO TRS 970 Annex 4). We ensure your validation reports are correctly presented in Module 3 (Quality).

• ZAZIBONA and SADC Alignment: Malawi is part of 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 manufacturers must provide acceptable GMP evidence or undergo a GMP inspection/assessment by the PMRA. Our strong validation reports are key evidence of the manufacturing site's state of control.

🎯 PMRA Compliance Focus: Who We Support

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

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

• GMP Conformance: Overseas facilities seeking PMRA 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 PMRA expectations.

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

🛠️ Our PMRA Process Validation Services

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

ServicePMRA / WHO / ZAZIBONA FocusPVP & PVR PreparationCustom protocols and reports aligned with WHO GMP (TRS), detailing the process validation lifecycle and ensuring robustness and repeatability.CTD Module 3 IntegrationStructuring validation summaries and data precisely for the CTD Module 3 format required by the PMRA, ensuring easy review.GMP Gap AssessmentReviewing your current validation documents and procedures against the stringent WHO GMP standards adopted by the PMRA and ZAZIBONA.Technical Defense & Query HandlingProviding expert technical defense and drafting precise responses to PMRA 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 Pharmacy and Medicines Regulatory Authority:

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

• ICH M4Q / WHO TRS 970 Annex 4 (CTD): Compliance with the mandated dossier structure.

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

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

🤝 Get Started on Your PMRA Validation

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

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

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

• Target PMRA 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 PMRA deficiency letters.