🇫🇯 ValiPro: Fiji MRA, WHO/SRA GMP & Provisional Registration Validation Services

Ensure Compliance and Secure Market Access in Fiji by Aligning with Fiji MRA's Quality, Prequalification, and Provisional Registration Requirements.

ValiPro provides expert Process Validation Protocol and Report services specifically designed for manufacturers targeting the Fiji market. Our documentation is built for full compliance with the rigorous standards enforced by the Fiji Medicines Regulatory Authority (Fiji MRA).

Key compliance pillars include:

• Mandatory compliance with Good Manufacturing Practice (GMP) standards from a recognized National Regulatory Authority (NRA).

• A registration pathway that includes Provisional Registration and, for government supply, mandatory Finished Pharmaceutical Product (FPP) Prequalification.

• Compliance with recognized Pharmacopeial Standards (BP, Ph. Eur., USP, or Ph. Int.).

🌟 Why Fiji MRA Validation is Crucial

Fiji is currently operating a Provisional Registration system, which allows for streamlined access for products already approved in Australia or New Zealand, but still demands high-quality, auditable documentation.

• Provisional Registration: The Medicinal Products Act 2011 requires all medicinal products to be registered. Fiji currently manages Provisional Medicinal Product Registration through its Online Services Portal. While documentation may be simplified for SRA-approved products, the underlying quality data, including validation, must be available upon request.

• Manufacturer GMP Prequalification: For manufacturers wishing to supply the Fiji Ministry of Health & Medical Services (MHMS) via the Fiji Pharmaceutical and Biomedical Services (FPBS), Prequalification of the manufacturer is mandatory. This requires:

  • A valid GMP certificate issued by a Fiji MRA-recognized NRA (including those designated by the WHO as an SRA or WLA, New Zealand, or PIC/S members).

  • Evidence that the site is approved to manufacture FPPs as described by PIC/S GMP requirements.

• Quality Data Reliance: Although full registration is provisional, the Fiji MRA relies on the Certificate of Pharmaceutical Product (CoPP) and the assessment by the reference NRA. Your detailed process validation and analytical method validation reports must fully support the claims made in that CoPP, as they are subject to review during the Prequalification phase.

• Language Requirement: All labels, packaging, and key documentation must be in the English language.

🎯 Compliance Focus: Who We Support

We work with international manufacturers targeting the Fiji market:

• Pharmaceutical Exporters: Targeting Provisional Registration for importation and distribution.

• Government Suppliers: Companies seeking mandatory Manufacturer Prequalification and FPP Prequalification to supply the Ministry of Health.

• GMP/Quality Compliance: Overseas facilities needing validation documentation that unequivocally meets the PIC/S or SRA standard to support their submitted GMP Certificate.

🛠️ Our Process Validation Services for Fiji

We provide complete, scientifically sound, and document-intensive support tailored to the quality requirements underpinning Fiji's registration and prequalification procedures.

ServiceFiji MRA / Prequalification FocusPVP & PVR PreparationCustom protocols and reports aligned with PIC/S GMP principles, detailing the process and cleaning validation lifecycle to support SRA/WHO GMP status.Quality Dossier IntegrationPreparing the technical summaries of the manufacturing process, control, and stability data required for the Provisional Registration and FPP Prequalification applications.Analytical Validation SupportPreparation of AMV reports to ensure compliance with the required pharmacopeial standards (BP, Ph. Eur., USP) and support the Finished Product Specifications.Prequalification Documentation ReviewReviewing and supplementing the validation package to ensure it fully supports the foreign manufacturer's GMP Certificate and CoPP required for Prequalification.

📜 Regulatory Standards We Follow

Our documentation is engineered to align with the core standards adopted and enforced by the Fiji Medicines Regulatory Authority:

• Medicinal Products Act 2011: The primary legislation governing registration.

• PIC/S GMP Guidelines: The internationally recognized standard for manufacturing practice required for Prequalification.

• Recognized Pharmacopeias: (BP, Ph. Eur., USP) for quality testing and specifications.

🤝 Get Started on Your Fiji Validation

Ensure your process validation documentation is robust, meets international SRA standards, and is immediately acceptable to the Fiji MRA for Provisional Registration and Government Prequalification.

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

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

• Target Status: Provisional Registration / FPP Prequalification

• Manufacturing Process: Overview of critical steps and control strategy

• Timeline: Submission date

• Existing Data: Any current validation documents or Fiji MRA queries.