🇨🇭 ValiPro: Swissmedic GMP Validation Services

Ensure Validation Documentation Meets PIC/S and EU GMP Standards to Support Swissmedic Marketing Authorization and Pass Rigorous Inspections.

ValiPro provides expert Process Validation services tailored to meet the strict GMP requirements enforced by Swissmedic for both Swiss-domiciled manufacturers and foreign sites supplying the Swiss market.

Key compliance pillars for market access in Switzerland include:

• National Authority (Swissmedic): Grants establishment licences, Marketing Authorizations, and conducts inspections to verify GMP/GDP compliance.

• Manufacturing Standard (PIC/S & EU GMP): The applicable standard is the PIC/S Guide to GMP and the EU GMP Guidelines.

• Validation Requirements: Mandatory 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: Applications must be submitted in the eCTD format, with all quality and validation data contained within Module 3 (Quality/CMC).

🌟 Why Validation is Crucial for Swissmedic Compliance

Swissmedic's inspection and assessment activities are known for their rigor. Compliance requires demonstrating that the entire quality system, starting with validation, is robust and scientifically justified.

1. Mandatory Qualification and Validation (PIC/S & EU GMP Annex 15)

Swissmedic enforces the modern, lifecycle approach to validation, checking for compliance with EU GMP Annex 15 principles:

• Process Validation Lifecycle: The three-stage approach is required.

  1. Process Design

  2. Process Performance Qualification (PPQ)

  3. Continued Process Verification (CPV)

• Qualification: All critical equipment and utilities 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, aligning with the strictest European and PIC/S expectations.

2. Proof of GMP Compliance for Foreign Manufacturers

Swissmedic has clear guidance on how foreign manufacturers must demonstrate GMP compliance, which directly impacts the validation package:

• Equivalence Principle: Manufacturers from countries with regulatory systems considered equivalent to Switzerland (like EU/EEA, US FDA, Japan MHLW, etc., often due to MRAs or PIC/S membership) submit official GMP Certificates.

• Non-Equivalent Countries: For manufacturers in countries not deemed equivalent, the Swiss Responsible Person (RP) must submit a Declaration of GMP Compliance supported by a recent (within 3 years) audit report. These sites are then added to a list for potential Swissmedic-led inspection, emphasizing that the underlying validation must be impeccable to withstand this scrutiny.

3. Focus on Advanced Therapies (ATMPs) and Data Integrity

Swissmedic is often a leader in complex regulatory areas:

• Aseptic Processing (Annex 1): For sterile products, compliance with the highly detailed EU GMP Annex 1 (Manufacture of Sterile Medicinal Products) is mandatory. Swissmedic is one of the first authorities to gain independent accreditation for inspecting GMP/GDP in the field of ATMPs (Advanced Therapy Medicinal Products), reflecting specialized validation expertise in this area.

• Data Integrity: Swissmedic inspectors focus heavily on Data Integrity for records supporting validation and QC results, aligning with the principles of ALCOA+ and EU GMP Annex 11 (Computerised Systems).

🎯 Compliance Focus: Who We Support

We work with manufacturers targeting the Swiss market:

• ATMP/Biotech Firms: Requiring specialized validation protocols aligned with the new, stricter EU GMP Annex 1 and the high expectations of the Swissmedic ATMP inspection unit.

• Foreign Manufacturers (Non-MRA Countries): Providing robust validation protocols and comprehensive audit reports to demonstrate compliance and satisfy Swissmedic's requirements for sites outside the mutual recognition system.

• Local Swiss Manufacturers: Seeking comprehensive VMPs and execution protocols to maintain PIC/S and EU GMP compliance for routine Swissmedic inspections.

🛠️ Our Process Validation Services for Swissmedic Compliance

We provide complete, scientifically sound, and internationally compliant validation documentation ready for Swissmedic submission and audit defense.

ServiceSwissmedic / PIC/S / EU GMP 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 Swissmedic's scientific quality assessment.

🤝 Next Step: Secure Swissmedic Validation Readiness

Ensure your validation documentation is robust, aligns with the mandatory PIC/S and EU GMP standards, and is ready to support your Swiss registration and GMP license application.

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

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

• Manufacturing Site Location: (For MRA assessment)

• Application Type: New MAA / Variation

• Timeline: Target submission date for Swissmedic