🇮🇱 ValiPro: MoH/ISCP (Israel) GMP Validation Services

Leverage Israel's Reliance Tracks and EU GMP Alignment to Streamline Registration. Ensure Validation Documentation Meets the ISCP's Exacting Quality Requirements.

ValiPro provides expert Process Validation services tailored to meet the strict GMP requirements enforced by the Israeli Ministry of Health and the ISCP for both domestic manufacturers and foreign sites supplying the Israeli market.

Key compliance pillars for market access in Israel include:

• National Authority (MoH/ISCP): The MoH grants the Marketing Authorization (MA). The ISCP is the technical body that reviews the Quality (CMC) Dossier and issues the required quality certificate.

• Reliance Tracks: The MoH offers expedited registration pathways (e.g., Reliance Track A: 70 days, Reliance Track B: 120 days) for products registered by recognized authorities (FDA, EMA, MHRA, HC, SMC, TGA). These tracks rely heavily on the accepted quality and validation data from these reference agencies.

• Manufacturing Standard (EU GMP/PIC/S): The ISCP explicitly references the EU GMP Guidelines and the PIC/S GMP Guide as its standards for pharmaceutical manufacturing and control.

• Dossier Submission: The application requires the submission of four dossiers (A-D). Quality and validation documentation is key to the ISCP's review for issuing the Quality Certificate.

🌟 Why Validation is Crucial for MoH/ISCP Compliance

For foreign manufacturers, the existing GMP certification (MRA) is essential. For all applicants, the validation data in the Quality dossier (CMC) must be robust and compliant with international standards to satisfy the ISCP's independent review.

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

The ISCP follows the EU GMP Guidelines, which means compliance with Annex 15 (Qualification and Validation) is the required standard for manufacturing sites supplying Israel.

• Process Validation Lifecycle: The modern, lifecycle approach to validation is expected, requiring a clear demonstration of process understanding, Process Performance Qualification (PPQ), and Continued Process Verification (CPV).

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

• Cleaning Validation: The scientific basis for Cleaning Validation, including the use of toxicologically derived limits (PDE/ADE), is expected, mirroring the strictest EU requirements.

2. Quality Dossier Review by the ISCP (Quality/CMC)

The ISCP performs an independent review of the quality documentation, even when utilizing reliance pathways. Validation summaries and data must be clearly presented.

• Analytical Method Validation (AMV): All in-house analytical testing methods must be validated according to ICH Q2(R1) principles to ensure reliable quality control results, matching the standards of the reference authority (EMA/FDA).

• API Validation: Active Pharmaceutical Ingredient (API) production must be validated according to ICH Q7 (API GMP) principles.

• Stability Data: Validation of the testing procedures used in the stability program is critical, often reviewed in relation to the local Israeli climate, despite reliance on foreign data.

3. Mutual Recognition Agreement (MRA) Impact

The MRA with the EU simplifies market entry by formally recognizing each other's GMP systems:

• Inspection Reliance: If a manufacturing site is covered by the MRA (i.e., it has an EU GMP certificate), the ISCP will generally recognize the inspection conclusions and the resulting GMP certificate.

• Batch Release: Batches released by a Qualified Person (QP) in the EU are recognized by Israel, eliminating the need for mandatory re-testing at the point of import. However, the quality certificate issued by the ISCP for the MA still relies on the original validation documentation.

🎯 Compliance Focus: Who We Support

We work with manufacturers targeting the Israeli market, leveraging the MRA and reliance system:

• Manufacturers with EU Approval: Assisting in compiling the validation summaries from the EU dossier to ensure seamless submission and acceptance by the ISCP under the Reliance Tracks.

• Manufacturers without EU Approval: Providing full-scale EU GMP/PIC/S-compliant validation services to meet the ISCP's standards for national submissions.

• Biotech and Injectables: Specialized validation protocols for sterile products, aligned with EU GMP Annex 1 (Manufacture of Sterile Medicinal Products).

🛠️ Our Process Validation Services for MoH/ISCP Compliance

We provide complete, scientifically sound, and internationally compliant validation documentation ready for MoH submission and ISCP review.

ServiceMoH/ISCP / EU GMP / PIC/S FocusEU GMP 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 EU GMP Annex 1.Dossier Gap AnalysisReview of existing validation data against the requirements of the recognized reference authority (e.g., FDA/EMA) and the specific needs of the ISCP review.CTD Module 3 Technical SupportStructuring and organizing validation summaries and data for inclusion in the Quality dossier (CMC) to pass the ISCP's assessment.

🤝 Next Step: Secure MoH Validation Readiness

Ensure your validation documentation is robust, aligns with the mandatory EU GMP/PIC/S guidelines, and is prepared to support your Israeli registration application, particularly under the expedited Reliance Tracks.

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

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

• Application Type: Reliance Track A/B/C or National Submission

• Reference Authority: (e.g., EMA, FDA) whose approval the application is relying on

• Timeline: Target submission date for the MoH