🇲🇺 ValiPro: Mauritius Pharmacy Board (PB), PIC/S & WHO GMP Validation Services

Achieve Compliance and Secure Product Registration in Mauritius with Internationally Aligned Validation Documentation.

ValiPro provides expert Process Validation Protocol and Report services tailored for manufacturers targeting the market in Mauritius. Our documentation is built for full compliance with the rigorous standards of the Pharmacy Board (PB), the central regulatory body, which strongly adheres to WHO Good Manufacturing Practices (WHO GMP) Guidelines and international standards, often referencing PIC/S principles.

We specialize in supporting manufacturers of human and veterinary medicines, APIs, and medical supplies, ensuring their validation packages secure timely PB approvals, minimize review deficiencies, and facilitate product registration and importation permits.

🌟 Why PB-Ready Validation is Crucial

The Pharmacy Board (PB) regulates the importation, distribution, and registration of medicines in Mauritius. Compliance with their standards is mandatory for market entry and is strictly aligned with globally recognized quality benchmarks.

• WHO/PIC/S GMP Mandate: The PB enforces GMP standards that closely follow the WHO Technical Report Series (TRS) and often expect compliance with principles equivalent to PIC/S. Your process validation documentation must conform precisely to these detailed international standards (e.g., WHO TRS Annex 3).

• Dossier Requirement: Product registration requires the submission of a comprehensive dossier. Validation reports for critical processes (manufacturing, cleaning, analytical methods) are a crucial part of the Quality Module reviewed by the PB.

• GMP Inspection/Recognition: Foreign manufacturing sites must hold a valid GMP certificate recognized by the PB. Our robust, internationally-aligned validation documentation is essential evidence for demonstrating a state of control during the PB's assessment process.

🎯 PB Compliance Focus: Who We Support

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

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

• GMP Conformance: Overseas facilities seeking PB recognition of their GMP status (based on WHO/PIC/S GMP).

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

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

🛠️ Our PB Process Validation Services

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

ServicePB / 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 PB's required submission format for the Quality Module.GMP Gap AssessmentReviewing your current validation documents and procedures against the stringent WHO GMP and PIC/S standards adopted by the PB.Technical Defense & Query HandlingProviding expert technical defense and drafting precise responses to PB assessors, ensuring queries are resolved quickly and effectively.

📜 Regulatory Standards We Follow

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

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

• 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 supports the modern, risk-based approach to validation favored by the PB.

🤝 Get Started on Your PB Validation

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

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

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

• Target PB 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 PB deficiency letters.