🇲🇻 ValiPro: MFDA (Maldives) Reliance and WHO-GMP Validation Services
Ensure Validation Documentation Meets MFDA's Reliance and WHO-GMP Requirements for Product Registration, Leveraging Approvals from Stringent Regulatory Authorities.
ValiPro supports foreign manufacturers targeting the Maldivian market by ensuring their validation documentation is robust, internationally compliant, and suitable for the MFDA's reliance-based and full review pathways.
Key compliance pillars for market access in Maldives include:
National Authority (MFDA): Responsible for registration/Marketing Authorization (MA) of medicines, with a focus on quality, safety, and efficacy.
Reliance Mechanism: MFDA has a Guideline on Good Reliance Practices, which facilitates expedited registration by utilizing assessments and decisions from Reference Regulatory Authorities (RRAs) (e.g., US FDA, EMA, TGA, Health Canada). Validation documentation approved by an RRA is highly beneficial.
Manufacturing Standard (WHO-GMP): Compliance with WHO-delineated Good Manufacturing Practice (GMP) is mandatory. Foreign manufacturers must submit a valid WHO-type GMP certificate from their national regulatory authority.
Dossier Requirement: The registration application requires comprehensive supporting documents, including proof of validation of the manufacturing method.
🌟 Why Validation is Crucial for MFDA Compliance
Validation is the core technical evidence required to prove the consistency and quality of the finished product, regardless of whether the registration proceeds via full evaluation or reliance pathways.
1. Mandatory Submission of Validation Proof
The MFDA's application checklist explicitly requires documented proof of process control:
Proof of Validation: Applicants must provide "The proof of validation of the manufacturing method for each standard batch size." (Source: MFDA Application for Registration of Pharmaceutical Product). This refers to the Process Validation documentation.
Analytical Method Validation (AMV): The dossier must include the Technical specifications of all raw material(s) and the finish product specification with reference to a recognized Pharmacopoeia (e.g., BP, USP, Ph. Eur.). The reliability of the specifications is tied to the validation of the analytical methods used for testing, aligning with ICH Q2(R1) principles.
API Validation: For sterile drug substances, a process validation report (where applicable) is required.
2. Adherence to WHO-GMP Principles
The MFDA's GMP guidelines are structured around the internationally accepted principles of WHO-GMP, which include:
System Controls: GMP requires the establishment and maintenance of controls for equipment, cleaning, calibration, and validation.
Qualification and Validation: The WHO-GMP framework mandates that manufacturers adhere to standard validation practices for critical systems, processes, and equipment to ensure products are consistently produced and controlled according to quality standards.
3. Reliance on Reference Authorities (RRAs)
The MFDA's reliance pathway is a strategic route to market access. Products approved by an RRA benefit from an abridged or verification review, where the validation data approved by the RRA serves as a significant regulatory safeguard.
RRA Approval: Submitting a copy of the product's registration granted by an RRA (along with the necessary cover letter) indicates that the validation documentation has already passed the scrutiny of a world-class regulator.
🎯 Compliance Focus: Who We Support
We work with foreign manufacturers targeting the Maldivian market:
WHO-GMP Certified Exporters: Assisting companies to summarize and structure their existing WHO-GMP or EU-GMP/US-FDA validation reports to meet the MFDA's explicit requirement for "proof of validation."
Manufacturers Utilizing Reliance: Preparing validation documents that align with the standards of major RRAs to expedite the MFDA registration process.
Generic Drug Applicants: Ensuring that all Process Validation and Analytical Method Validation data is robust, verifiable, and suitable for the MFDA's scientific review and reliance pathways.
🛠️ Our Process Validation Services for MFDA Compliance
We provide robust, internationally accepted (WHO-GMP compliant) validation documentation ready for MFDA submission.
ServiceMFDA / WHO-GMP / Reliance FocusProcess Validation SummaryPreparation of a dedicated summary report proving the validation of the manufacturing method for the standard batch size, meeting the MFDA checklist requirement.Analytical Method Validation (AMV)Execution and reporting of Method Validation studies (ICH Q2 principles) for all QC tests, ensuring compliance with the cited Pharmacopoeia.WHO-GMP Documentation ReviewReview of the facility's VMP and qualification records (IQ/OQ/PQ) to ensure they align with the submitted WHO-type GMP Certificate.Reliance Dossier SupportEnsuring all validation data is correctly referenced and consistent with the RRA approval documents used for the reliance application.
🤝 Next Step: Secure MFDA Validation Readiness
Ensure your validation documentation is robust, traceable, and fully compliant with the MFDA's requirements to successfully obtain product registration and import authorization in the Maldives.
To receive a Technical Scope and Commercial Proposal tailored for your Maldives project, simply provide:
Product: Active Pharmaceutical Ingredient (API) or Finished Formulation
Current GMP Certification: (e.g., WHO-GMP, EU GMP, US FDA)
Registration Pathway: Reliance (RRA exists) / Full Evaluation
Timeline: Target submission date for the MFDA