🇮🇹 ValiPro: AIFA (Italy) EU GMP Validation Services

Ensure Flawless Validation Documentation (eCTD Module 3) for AIFA 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 AIFA for both local Italian manufacturers and foreign sites supplying the market.

Key compliance pillars for market access in Italy include:

• National Authority (AIFA): Responsible for coordinating and managing inspections to verify GMP compliance of manufacturers and importers of medicinal products and Active Pharmaceutical Ingredients (APIs).

• Manufacturing Standard (EU GMP/PIC/S): All manufacturing, importation, and testing activities must comply with the EU Guidelines to Good Manufacturing Practice, including Part I (Medicinal Products), Part II (APIs - ICH Q7), and all relevant Annexes.

• Validation Requirements: Strict adherence to the lifecycle approach to validation, aligning with ICH Q8, Q9, and Q10, and mandatory compliance with EU GMP Annex 15 (Qualification and Validation).

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

🌟 Why Validation is Crucial for AIFA Compliance

AIFA's inspection program is rigorous, covering both finished products and API manufacturing. Validation documentation is the key evidence required to secure and maintain both the Manufacturing/Import Authorization and the GMP Certificate.

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

AIFA inspectors, in collaboration with ISS experts, conduct periodic and preventive inspections based entirely on adherence to EU GMP Annex 15 principles.

• Process Validation Lifecycle: The lifecycle approach is mandatory. AIFA inspections verify that the entire process—from Design to Continued Verification—is scientifically justified and documented.

  1. Process Design

  2. Process Performance Qualification (PPQ)

  3. Continued Process Verification (CPV)

• Qualification: The Italian inspectorate requires meticulous Qualification (DQ, IQ, OQ, PQ) of all critical utilities (especially water and HVAC systems) and manufacturing equipment, with documented evidence being a primary focus area during audits.

• Cleaning Validation: For multi-product facilities, Cleaning Validation protocols and reports must be based on a toxicological assessment using Permitted Daily Exposure (PDE) limits, a critical requirement for Annex 15 compliance.

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

The eCTD submission to AIFA must contain robust validation data to pass scientific assessment:

• API Validation: AIFA's GMP Inspections and Manufacturing Authorisations of APIs Office is responsible for inspecting API sites both in Italy and abroad (based on risk assessment). The dossier in Module 3.2.S.2.5 (Process Validation and/or Evaluation) must include validation data for API aseptic processing and sterilization.

• Validation Master Plan (VMP): AIFA inspection documents explicitly require an updated list of qualifications and validations, often housed within a site's VMP. This plan must cover all GxP-relevant activities, including Analytical Method Validation (AMV) and Computer System Validation (CSV).

3. AIFA GMP Audits and Certificates

AIFA conducts various types of inspections, including preventive, periodic, follow-up, and extraordinary inspections.

• GMP Certificate: Following a successful periodic inspection, AIFA issues the GMP Certificate, which is usually relied upon for three years. The validation data is the foundation of the PQS that allows the GMP certificate to be issued and renewed.

• Non-EU Inspections: AIFA has the right to conduct inspections at non-EU manufacturing plants if there is a relevant interest or upon a manufacturer's request, underscoring the necessity for international sites to maintain an Italian-compliant validation program.

🎯 Compliance Focus: Who We Support

We work with manufacturers targeting the Italian market:

• API Manufacturers: Requiring validation documentation and comprehensive VMPs compliant with ICH Q7 (API GMP) to support AIFA/EU inspections and maintain GMP certificates for API manufacturing.

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

• Foreign Manufacturers/Importers: Needing validation dossiers that meet the stringent AIFA/EU GMP requirements to support the MAA and the Qualified Person's batch release responsibility in the EU.

🛠️ Our Process Validation Services for AIFA Compliance

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

ServiceAIFA / 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 AIFA's scientific quality assessment.

🤝 Next Step: Secure AIFA Validation Readiness

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

To receive a Technical Scope and Commercial Proposal tailored for your Italy 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 AIFA