🇬🇧 ValiPro: MHRA (UK) GMP Validation Services

Ensure Flawless Validation Documentation (CTD Module 3) for MHRA Registration and Pass Mandatory GMP Audits by Adhering to UK GMP and ICH Guidelines.

ValiPro provides expert Process Validation services specifically tailored to meet the strict GMP requirements enforced by the MHRA for manufacturers holding a UK Manufacturer’s/Importer’s Authorisation (MIA).

Key compliance pillars for market access and manufacturing in the UK include:

• National Authority (MHRA): The independent regulatory body responsible for granting Marketing Authorisations (MA), Manufacturer’s/Importer’s Authorisations (MIA), and enforcing GMP through inspections across the UK.

• Manufacturing Standard (UK GMP): The UK's domestic GMP standard is based on the EU GMP text (as retained in UK law), including the principles of PIC/S.

• Validation Requirements: Strict adherence to UK GMP Annex 15 (Qualification and Validation) is the definitive standard for all validation activities in the UK.

• Dossier Submission: All applications for MA must be submitted in the eCTD format (via the MHRA Portal), with all validation data contained within Module 3 (Quality/CMC).

🌟 Why Validation is Crucial for MHRA Compliance

The MHRA conducts thorough scientific assessments and is globally recognized for its detailed GMP inspections. Validation serves as the primary evidence that your manufacturing process is consistently controlled and reproducible.

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

The MHRA inspection unit enforces UK GMP Annex 15 (Qualification and Validation) principles rigorously. This mandates a lifecycle, risk-based approach to validation:

• Process Validation Lifecycle: The modern, three-stage approach (ICH Q8, Q9, Q10) is required:

  1. Process Design: Establishing robust process understanding.

  2. Process Performance Qualification (PPQ): Confirmation of commercial-scale consistency.

  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). The Water System Validation and HVAC Qualification are consistently high-focus areas during MHRA audits.

• Cleaning Validation: Must be scientifically justified, with acceptance criteria based on a toxicological evaluation using Permitted Daily Exposure (PDE) or Acceptable Daily Exposure (ADE) limits, as mandated by Annex 15.

2. Marketing Authorisation Submission (eCTD Module 3)

The Quality Module (Module 3) of the eCTD dossier submitted to the MHRA must contain technically robust validation data.

• Analytical Method Validation (AMV): All analytical testing methods must be validated according to ICH Q2(R1) to ensure reliable Quality Control results.

• API Validation: Active Pharmaceutical Ingredient (API) production must be validated according to ICH Q7 (API GMP) principles. The MHRA requires verification of the API supplier's GMP compliance via an acceptable GMP certificate (e.g., from the MHRA itself, or a satisfactory inspection from an equivalent regulator).

• Aseptic Processes (Annex 1): For sterile products, compliance with the highly detailed requirements of the revised UK GMP Annex 1 (which is identical to the EU GMP Annex 1) is essential, including validation of Aseptic Process Simulations (Media Fills).

3. MHRA GMP Audits

The MHRA conducts routine GMP inspections of domestic sites and issues GMP certificates essential for market access.

• Audit Focus: Inspections focus on the effectiveness of the Pharmaceutical Quality System (PQS), ensuring the Validation Master Plan (VMP) is executed and that the facility maintains its validated state via robust Change Control and Revalidation procedures.

• Qualified Person (QP) Reliance: The MHRA closely scrutinizes the reliance placed by the QP on the validation data when certifying batches for release onto the UK market.

🎯 Compliance Focus: Who We Support

We work with manufacturers targeting the UK market:

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

• Foreign MIA Holders: Needing robust validation documentation to support the QP’s batch certification for products imported into the UK.

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

🛠️ Our Process Validation Services for MHRA Compliance

We provide complete, scientifically sound, and UK GMP-compliant validation documentation ready for MHRA submission and audit defense.

ServiceMHRA / UK GMP / PIC/S FocusUK GMP VMP & PVDevelopment of a Validation Master Plan (VMP) and Process Performance Qualification (PPQ) protocols aligned with UK GMP Annex 15.Aseptic Processing ValidationSpecialized validation for sterile manufacturers, including Aseptic Process Simulation (Media Fills), aligning with UK GMP Annex 1.Cleaning Validation (PDE/ADE)Calculation of health-based limits (PDE/ADE) and execution of Cleaning Validation protocols to meet Annex 15 requirements.eCTD Module 3 Technical SupportStructuring and organizing validation summaries and data for inclusion in the eCTD Module 3 to pass the MHRA's scientific assessment.

🤝 Next Step: Secure MHRA Validation Readiness

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

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

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

• Application Type: UK MAA / MIA Application / Variation to Existing MA

• Manufacturing Process: Overview of critical steps and control strategy

• Timeline: Target submission date for MHRA