🇶🇦 ValiPro: PDCD (Qatar) GCC/ICH GMP Validation Services

Ensure Validation Documentation Conforms to the eCTD Structure and GCC Guidelines (Ministerial Resolution) for Successful PDCD Product and Manufacturer Registration.

ValiPro provides expert Process Validation services tailored to meet the strict GMP and technical dossier requirements enforced by the PDCD for foreign manufacturers supplying the Qatari market. The PDCD has adopted the eCTD format and rigorous technical validation processes based on GCC specifications.

Key compliance pillars for market access in Qatar include:

• National Authority (PDCD/MoPH): Manages the registration of the manufacturer, the local agent, and the product. It performs scientific review and technical validation of the dossier.

• Dossier Format (eCTD): Product registration files must be submitted electronically in the eCTD format via the PDCD e-system. This requires meticulous organization of validation data within Module 3 (Quality/CMC).

• Manufacturing Standard (International GMP): Compliance with international GMP standards (e.g., EU GMP, US FDA, WHO GMP) is mandatory, as evidenced by a valid GMP Certificate and a Site Master File (SMF) (often required in WHO format).

• Traceability/Serialization: Qatar mandates a GS1-compliant serialization and Track and Trace system, which requires the validation of all associated computerized systems.

🌟 Why Validation is Crucial for PDCD Compliance

Validation documentation is the core technical data assessed during the PDCD's technical review. The scientific reviewers verify the consistency and quality of the product based on this evidence.

1. Mandatory Submission in eCTD Module 3 (Quality)

The PDCD's submission requirements, harmonized through the GCC, mandate a full Common Technical Document (CTD) structure, with validation data explicitly required:

• Process Validation (3.2.P.3): The dossier must include a detailed description of the manufacturing process, identification of critical steps, and a summary of the Process Validation (PV) studies. This proves the commercial-scale process is consistently capable of producing a product meeting specifications.

• Analytical Method Validation (AMV) (3.2.P.5.3): The CTD structure requires detailed submission of reports on the Validation of Analytical Procedures (AMV). These must comply with ICH Q2(R1) principles to ensure the reliability of all quality control testing (e.g., assay, purity, dissolution).

• Site Master File (SMF): The SMF, required to be submitted, must contain details on the facility's quality management system, including the validation program (e.g., Validation Master Plan).

2. High GMP and Data Integrity Standards

The PDCD ensures compliance through site registration approvals and adherence to global standards:

• GCC GMP Standards: Qatar's regulatory stance is aligned with the GHC, which accepts certificates from major SRAs, implying that the standard of Qualification (IQ/OQ/PQ) for equipment/utilities, Process Validation, and Cleaning Validation must align with best-in-class international GMP guidelines.

• Serialization Compliance: Qatar's implementation of a mandatory Track and Trace system based on GS1 standards requires that all serialization and aggregation systems, including the data reporting system to the MoPH, undergo rigorous Computer System Validation (CSV) to ensure Data Integrity throughout the supply chain.

3. Technical Validation and Review Process

The PDCD review process involves specific validation checks:

• Technical Validation: The submitted eCTD file undergoes a "technical validation based on the latest GCC validation specifications." This check ensures the dossier structure and content integrity meet the strict electronic submission requirements.

• QC Sample Analysis: The PDCD requests samples and standards for QC analysis purposes. The ability of the drug to pass the PDCD's independent quality control testing relies entirely on the consistency achieved by the manufacturer's validated process.

🎯 Compliance Focus: Who We Support

We work with foreign manufacturers targeting the Qatari market:

• International Exporters: Assisting in compiling robust CTD Module 3 documentation, ensuring all validation summaries meet the scientific and technical scrutiny of the PDCD.

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

• Manufacturers Implementing Serialization: Providing Computer System Validation (CSV) services for serialization systems to ensure compliance with the Qatar Track and Trace mandate.

🛠️ Our Process Validation Services for PDCD Compliance

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

ServicePDCD / GCC / eCTD FocusCTD Module 3 CompilationStructuring and writing the validation summaries for inclusion in the specific sections of CTD Module 3 (Quality), explicitly covering PV and AMV.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.Serialization (CSV) & Data IntegrityValidation of the Computer Systems supporting the Qatar Track and Trace and serialization systems to meet the regulatory mandate.