🇫🇷 ValiPro: ANSM (France) EU GMP Validation Services

Ensure Flawless Validation Documentation (eCTD Module 3) for ANSM 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 ANSM for both domestic French manufacturers and foreign sites supplying the highly quality-sensitive French market.

Key compliance pillars for market access in France include:

• National Authority (ANSM): The central authority responsible for granting manufacturing and import authorizations, conducting rigorous GMP inspections, and evaluating the Quality (CMC) dossier for Marketing Authorizations (MAA).

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

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

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

🌟 Why Validation is Crucial for ANSM Compliance

ANSM's Inspection Division is known for its technical rigor. Failure to maintain a validated state is a common observation leading to regulatory action (e.g., injunctions, suspension of activity).

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

ANSM inspectors enforce the principles of EU GMP Annex 15, which dictates a modern, risk-based, and lifecycle approach to validation:

• Process Validation Lifecycle: The lifecycle approach is mandatory, requiring scientific justification for process understanding and control strategy.

  1. Process Design: Establishing process understanding.

  2. Process Performance Qualification (PPQ): Confirmation of commercial-scale consistency (e.g., the traditional three-batch approach or hybrid).

  3. Continued Process Verification (CPV): Ongoing monitoring to maintain the validated state throughout the product life cycle.

• Qualification: All critical equipment and utilities must be fully Qualified (DQ, IQ, OQ, PQ). ANSM emphasizes the importance of User Requirements Specifications (URS) as the starting point for Qualification.

• Cleaning Validation: The acceptance criterion "visibly clean" is not acceptable as the single criterion. Limits for cross-contamination must be based on a toxicological evaluation using Permitted Daily Exposure (PDE) limits, as per Annex 15 requirements.

2. Data Integrity (ALCOA+)

ANSM and EU regulators place an extremely high focus on Data Integrity, particularly for the records supporting validation:

• Principle: All data, including electronic validation records, must adhere to ALCOA+ principles: Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available.

• Computer System Validation (CSV): Any computerized system used in a GxP function (e.g., LIMS, SCADA, ERP systems controlling production, data acquisition systems for OQ/PQ) must be fully validated according to EU GMP Annex 11 and Data Integrity standards.

3. ANSM GMP Audits

ANSM conducts routine and targeted GMP inspections both nationally and internationally as part of the EU network.

• Audit Focus: Audits focus on the effectiveness of the Pharmaceutical Quality System (PQS), the maintenance of the Validation Master Plan (VMP), and verifying that the entire system (equipment, utilities, processes, and cleaning) remains in a Validated State through robust change control and periodic review.

• Aseptic Compliance: For sterile manufacturers, inspections strictly verify adherence to the revised, highly prescriptive EU GMP Annex 1 (Manufacture of Sterile Medicinal Products).

🎯 Compliance Focus: Who We Support

We work with manufacturers targeting the French market:

• Biotech and Injectables: Requiring specialized validation protocols for sterile products, aligned with the stringent EU GMP Annex 1.

• Foreign Importers: Needing robust validation documentation to support the Qualified Person's (QP's) certification of batches imported into the EU via France.

• Local French Manufacturers: Seeking comprehensive VMPs, Data Integrity gap analyses, and execution protocols to maintain the highest level of compliance for routine ANSM inspections.

🛠️ Our Process Validation Services for ANSM Compliance

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

ServiceANSM / 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.Data Integrity & CSVComputer System Validation (CSV) and Data Integrity assessments (ALCOA+) for systems impacting GMP, aligning with EU GMP Annex 11.

🤝 Next Step: Secure ANSM Validation Readiness

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

To receive a Technical Scope and Commercial Proposal tailored for your France 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 ANSM