🇩🇪 ValiPro: BfArM/PEI (Germany) EU GMP Validation Services

Ensure Flawless Validation Documentation (eCTD Module 3) for BfArM/PEI Registration and Pass Stringent GMP Audits by Adhering to PIC/S GMP and German Inspectorate Guidance.

ValiPro provides expert Process Validation services specifically tailored to meet the strict EU GMP requirements enforced by the German federal and state authorities for manufacturers supplying the German market.

Key compliance pillars for market access in Germany include:

• Manufacturing Standard (EU GMP/PIC/S): Compliance with the EU Guidelines to Good Manufacturing Practice is mandatory, including the principles of PIC/S.

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

• National Inspection Guidance: State authorities (Länder authorities) handle local enforcement, including inspections, often utilizing internal guidance, such as the Aide Memoire on Qualification/Validation published by the German Inspectorate (ZLG), which provides detailed interpretation of the EU GMP Annex 15.

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

🌟 Why Validation is Crucial for German Compliance

German authorities are globally recognized for their stringent validation and Data Integrity requirements. Validation is the primary evidence for the quality review and inspection success.

1. Mandatory Qualification and Validation (EU GMP Annex 15 & German Aide Memoire)

German inspectors strictly check for full adherence to EU GMP Annex 15 principles.

• Process Validation Lifecycle: The lifecycle approach is mandatory. Inspectors specifically look for demonstration of process understanding and knowledge, confirming that 3 validation cycles are not sufficient anymore unless scientifically justified.

  • Process Design

  • Process Performance Qualification (PPQ)

  • Continued Process Verification (CPV): Modern aspects of revalidation strongly remind of this stage 3 requirement.

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

• Cleaning Validation: Acceptance criteria must be based on a toxicological evaluation using Permitted Daily Exposure (PDE) limits. The German Aide Memoire often focuses on Hygienic Design as a fundamental requirement for cleanability, emphasizing design aspects of equipment.

2. Marketing Authorization Submission (eCTD Module 3)

The eCTD submission to BfArM (or PEI for biologicals) must be technically sound:

• eCTD Validation Criteria: Germany mandates specific, strict validation criteria for eCTD submissions (e.g., v8.2 is mandatory as of December 1, 2025). Formal errors in the submission, including faulty documentation in Module 3, can lead to immediate rejection.

• Analytical Method Validation (AMV): All analytical methods must be validated according to ICH Q2(R1) principles to ensure the required pharmaceutical quality is met.

3. Inspection Rigor and Data Integrity

The state authorities conduct GMP inspections and are focused on system compliance:

• Data Integrity (ALCOA+): German authorities place a major emphasis on the integrity and accuracy of the data supporting all validation efforts, including electronic records. This is assessed against EU GMP Annex 11 (Computerised Systems).

• Länder Authorities: Compliance relies not just on the federal authorities (BfArM/PEI) but also on the competent state authorities (Länder) who enforce the GMP rules locally.

🎯 Compliance Focus: Who We Support

We work with manufacturers targeting the German market:

• Biological and ATMP Manufacturers (PEI): Requiring specialized validation protocols for sterile products, aligned with the stringent EU GMP Annex 1 and specific PEI expectations for biologics.

• Chemical/Herbal Manufacturers (BfArM): Needing robust process and cleaning validation to support MAA submissions and pass routine inspections by the Länder authorities.

• Foreign Manufacturers: Assisting in compiling comprehensive validation summaries that satisfy the high scientific review standards of BfArM/PEI.

🛠️ Our Process Validation Services for BfArM/PEI Compliance

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

ServiceBfArM/PEI / 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 and German Aide Memoire requirements.eCTD Module 3 Technical SupportStructuring and organizing validation summaries and data for inclusion in the eCTD Module 3 to pass the BfArM/PEI's scientific assessment.

🤝 Next Step: Secure German Validation Readiness

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

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

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

• 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 BfArM or PEI