🇵🇹 ValiPro: INFARMED (Portugal) EU GMP Validation Services

Ensure Flawless Validation Documentation (eCTD Module 3) for INFARMED 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 INFARMED for manufacturers supplying the Portuguese market.

Key compliance pillars for market access in Portugal include:

• National Authority (INFARMED): Responsible for authorizing and inspecting manufacturers, wholesalers, and pharmacies to ensure compliance with GMP, GDP (Good Distribution Practices), and GPP (Good Pharmacy Practices).

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

• Validation Requirements: Mandatory adherence to the lifecycle approach to validation, aligning with ICH Q8, Q9, and Q10 guidelines, ensuring continuous control of the manufacturing process.

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

🌟 Why Validation is Crucial for INFARMED Compliance

INFARMED's regulatory functions cover both the scientific assessment of the Quality dossier and the on-site inspection for GMP compliance. Validation is the foundational evidence required for success in both areas.

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

INFARMED inspectors strictly enforce the principles of EU GMP Annex 15, which mandates a documented, lifecycle approach to validation:

• Process Validation Lifecycle: The modern, three-stage approach is required, verifying the entire process:

  1. Process Design

  2. Process Performance Qualification (PPQ)

  3. Continued Process Verification (CPV)

  Retrospective validation is no longer considered acceptable for new or modified processes.

• Qualification: Comprehensive Qualification (DQ, IQ, OQ, PQ) of all critical facilities, utilities (e.g., HVAC, Water Systems), and equipment must be executed and maintained.

• Cleaning Validation: For shared manufacturing equipment, Cleaning Validation must be performed using scientifically justified limits, typically based on a toxicological evaluation using Permitted Daily Exposure (PDE) limits, as required by Annex 15.

2. Quality Dossier Assessment by INFARMED (eCTD Module 3)

The Quality Module of the eCTD dossier must contain robust validation data to pass INFARMED's scientific assessment:

• Process Description (3.2.P.3): The process description must include summaries of the validation studies (PPQ and CPV plans) confirming the process is consistent and under control.

• Analytical Method Validation (AMV): All analytical testing methods (for release and stability) must be validated according to ICH Q2(R1) principles to ensure the reliability of the Quality Control results submitted in the dossier.

3. INFARMED GMP Audits

INFARMED conducts routine GMP inspections of Portuguese manufacturing sites and participates in the EU-wide system of GMP inspections for foreign sites.

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

• GMP Certificate: Following a successful inspection, INFARMED issues a GMP Certificate (recorded in the EudraGMDP database), which is relied upon for batch release by the Qualified Person (QP).

🎯 Compliance Focus: Who We Support

We work with manufacturers targeting the Portuguese 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 INFARMED/EU GMP requirements to support the MAA and the QP's batch release responsibility.

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

🛠️ Our Process Validation Services for INFARMED Compliance

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

ServiceINFARMED / 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 INFARMED's scientific quality assessment.

🤝 Next Step: Secure INFARMED Validation Readiness

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

To receive a Technical Scope and Commercial Proposal tailored for your Portugal 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 INFARMED