🇲🇹 ValiPro: MMA (Malta) EU GMP Validation Services

Ensure Flawless Validation Documentation (eCTD Module 3) for MMA Registration and Pass Mandatory GMP Audits by Adhering to PIC/S GMP and ICH Guidelines.

ValiPro provides expert Process Validation services specifically tailored to meet the strict EU GMP requirements enforced by the MMA for both local Maltese manufacturers and foreign sites supplying the market.

Key compliance pillars for market access in Malta include:

• National Authority (MMA): The Maltese body responsible for granting Marketing Authorizations (MAA) and enforcing GMP/GDP through inspections.

• Manufacturing Standard (EU GMP/PIC/S): All manufacturing, importation, and testing activities must comply with the EU Guidelines to Good Manufacturing Practice and, specifically, Annex 15 (Qualification and Validation).

• Qualified Person (QP): The QP, whose eligibility is strictly regulated by the MMA, is legally responsible for certifying that every batch has been manufactured and checked in accordance with the MA and GMP. This relies directly on a validated state.

• Dossier Submission: MAA must be submitted electronically in the eCTD format via CESP, with all quality and validation data contained within Module 3 (Quality/CMC).

🌟 Why Validation is Crucial for MMA Compliance

Validation is the core technical requirement proving a manufacturing process is consistently capable of producing a safe and effective product. The MMA checks this at two stages: dossier review and on-site inspection.

1. Mandatory Qualification and Validation (EU GMP Annex 15)

The MMA requires full adherence to the principles laid out in EU GMP Annex 15 (Qualification and Validation), ensuring a scientifically justified, lifecycle approach to quality assurance:

• Process Validation Lifecycle: The modern approach is mandatory, requiring three key stages:

  1. Process Design: Establishing process understanding and control strategy.

  2. Process Performance Qualification (PPQ): Executing commercial-scale batches to confirm process consistency.

  3. Continued Process Verification (CPV): Ongoing monitoring to assure the process remains in a validated state throughout the product life cycle.

• Qualification: All critical utilities (e.g., Water Systems, HVAC) and equipment must be fully Qualified (DQ, IQ, OQ, PQ).

• Cleaning Validation: Acceptance criteria for cleaning must be based on a toxicological evaluation using Permitted Daily Exposure (PDE) limits, as mandated by Annex 15 for shared facilities.

2. Marketing Authorization Submission (eCTD Module 3)

The Quality Module (Module 3) of the eCTD dossier submitted to the MMA must contain robust validation data:

• Manufacturing Process (3.2.P.3): This section must detail the manufacturing process and include a summary of the validation studies (PPQ and CPV plans) proving the consistency and control of the process.

• Analytical Method Validation (AMV): All testing methods used by Quality Control (QC) must be validated according to ICH Q2(R1) principles to ensure the reliability and accuracy of batch release results.

3. MMA GMP Audits and QP Reliance

The MMA conducts routine GMP inspections of domestic sites and issues GMP Certificates in the EudraGMDP database.

• Inspection Focus: Inspections focus on the entire Pharmaceutical Quality System (PQS), with heavy emphasis on the Validation Master Plan (VMP), executed protocols, and the management of change control as it affects the validated state.

• QP Responsibility: The Maltese-approved QP relies on documented validation to perform their batch certification duties. Deficient validation can directly lead to a failure in QP certification and batch release stoppage.

🎯 Compliance Focus: Who We Support

We work with manufacturers targeting the Maltese market:

• Aseptic/Sterile Manufacturers: Requiring specialized validation protocols for sterile products, aligned with the revised, stricter EU GMP Annex 1 (Manufacture of Sterile Medicinal Products).

• Foreign Manufacturers (Importers): Needing validation dossiers that meet the stringent MMA/EU GMP requirements to support the MAA and the QP's batch release responsibility.

• Local Maltese Manufacturers: Seeking comprehensive VMPs and execution protocols to maintain the highest level of compliance for routine MMA inspections.

🛠️ Our Process Validation Services for MMA Compliance

We provide complete, scientifically sound, and EU-compliant validation documentation ready for MMA submission and audit defense.

ServiceMMA / EU GMP / PIC/S FocusPIC/S VMP & PVDevelopment of a Validation Master Plan (VMP) and Process Performance Qualification (PPQ) protocols aligned with EU GMP Annex 15.Aseptic Processing ValidationSpecialized validation for sterile manufacturers, including Aseptic Process Simulation (Media Fills), aligning with the new EU GMP Annex 1.Cleaning Validation (PDE/ADE)Calculation of health-based limits (PDE/ADE) and execution of Cleaning Validation protocols to meet the stringent Annex 15 requirements.eCTD Module 3 Technical SupportStructuring and organizing validation summaries and data for inclusion in the eCTD Module 3 to pass the MMA's scientific quality assessment.

🤝 Next Step: Secure MMA Validation Readiness

Ensure your validation documentation is robust, aligns with the mandatory EU GMP and ICH guidelines, and is ready to support your Maltese registration and GMP license application.

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

• Product: Active Pharmaceutical Ingredient (API) or Finished Formulation (e.g., sterile injectable, tablet)

• Application Type: National MAA / Decentralized Procedure (DCP) / Mutual Recognition Procedure (MRP)

• Manufacturing Process: Overview of critical steps and control strategy

• Timeline: Target submission date for the MMA