🇰🇼 ValiPro: KDFC (Kuwait) GCC/ICH GMP Validation Services

Ensure Validation Documentation Conforms to the CTD Structure and GCC Guidelines (Ministerial Decree No. 361 of 2019) for Successful KDFC Product and Manufacturer Registration.

ValiPro provides expert Process Validation services specifically tailored to meet the strict GMP and technical dossier requirements enforced by the KDFC for foreign manufacturers supplying the Kuwaiti market.

Key compliance pillars for market access in Kuwait include:

• National Authority (KDFC/MoH): Manages the registration of the manufacturer, the local agent, and the product.

• Dossier Format (CTD): Product registration files are required to conform to the Common Technical Document (CTD) structure, adopted by the GHC.

• Manufacturing Standard (International GMP): Manufacturers must hold a Legalized Valid Good Manufacturing Practice (GMP) Certificate from the Health Authority in the country of origin. This certificate is granted based on adherence to global standards (e.g., EU GMP, US FDA, WHO GMP).

• Stability Studies: Stability data must adhere to ICH guidelines for Climate Zone III & IV (long-term $30^{\circ}\text{C} \pm 2^{\circ}\text{C} / 65 \pm 5\% \text{RH}$; accelerated $40^{\circ}\text{C} \pm 2^{\circ}\text{C} / 75 \pm 5\% \text{RH}$).

🌟 Why Validation is Crucial for KDFC Compliance

Validation documentation is a specific and mandatory component of the CTD Module 3 (Quality) submission. The KDFC uses this data to conduct a thorough technical evaluation and to verify the quality system of the manufacturing site.

1. Mandatory Submission in CTD Module 3

Ministerial Decree No. 361 of 2019 specifies the required information for the technical sections of the dossier (Module 3), where validation is a key element:

• Control of Drug Substance (Module 3.2.S): Requires documentation on the Description of Process and Process Control for the Active Pharmaceutical Ingredient (API).

• Control of Drug Product (Module 3.2.P): Requires the following sections, all dependent on validation:

  • Analytical Procedure

  • Validation of Analytical Procedure (a specific required section)

  • Description of Process and Process Control

  • Validation of the Manufacturing Process (a specific required section)

2. Good Manufacturing Practice (GMP) and Site Approval

The KDFC requires proof that the entire quality system is validated, as demonstrated by the site's GMP certificate and the accompanying Site Master File (SMF).

• SMF Requirement: The required Site Master File must contain details on Quality control unit and quality management, which includes a description of the validation program (e.g., Validation Master Plan).

• Process Validation (PV): Manufacturing facilities must have documented evidence that critical steps of manufacturing processes and significant changes to the process are validated, ensuring that the process is consistently capable of producing a finished product meeting its pre-determined specifications.

• Qualification (IQ/OQ/PQ): Compliance with international GMP requires that all critical equipment, utilities (like water systems), and facilities (like HVAC/cleanrooms) are fully Qualified (IQ, OQ, PQ).

3. Analytical Method Validation (AMV) and Stability

The reliability of the quality data submitted is directly assessed via AMV data:

• Validation of Analytical Procedure: This requirement mandates full analytical method validation reports in line with ICH Q2(R1) principles, covering tests for identification, purity, and assay.

• Bioequivalence (BE) Studies: For generic drugs, submission of BE study data is required. The analytical methods used for sample testing in the BE study must be fully validated (Bioanalytical Method Validation) and comply with GHC/ICH guidelines.

🎯 Compliance Focus: Who We Support

We work with foreign manufacturers targeting the Kuwaiti market:

• International Exporters: Assisting in compiling robust CTD Module 3 documentation, ensuring all validation summaries meet the stringent KDFC requirements for technical approval.

• Generic Drug Applicants: Providing fully compliant Process Validation and Analytical Method Validation data to support the quality and BE claims in the dossier.

• Manufacturers Seeking GCC-Wide Registration: Aligning validation programs with the unified standards of the GHC and ICH guidelines.

🛠️ Our Process Validation Services for KDFC Compliance

We provide complete, scientifically sound, and internationally accepted validation documentation ready for KDFC submission.

ServiceKDFC / GCC / CTD FocusCTD Module 3 CompilationStructuring and writing the validation summaries for inclusion in the specific sections of CTD Module 3 (Quality).ICH Process ValidationDevelopment of Process Performance Qualification (PPQ) protocols and reports for critical manufacturing steps, in line with ICH Q8/Q10 principles.Analytical Method Validation (AMV)Execution and reporting of Method Validation studies (ICH Q2 principles) for all QC tests, including Bioanalytical methods.Qualification & Cleaning ValidationDocumentation to support the Qualification (IQ/OQ/PQ) of critical equipment and Cleaning Validation protocols to meet international GMP standards.

🤝 Next Step: Secure KDFC Validation Readiness

Ensure your validation documentation is robust, aligned with the mandatory CTD format, and ready to support your product and manufacturer registration in Kuwait.

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

• Product: Active Pharmaceutical Ingredient (API) or Finished Formulation

• Dossier Format: CTD (already compiled) or CTD (needs compilation)

• Current GMP Certification: (e.g., US FDA, EMA/EU GMP, WHO GMP)

• Timeline: Target submission date for the KDFC