🇴🇲 ValiPro: DGPA&DC (Oman) GCC/ICH GMP Validation Services
Ensure Validation Documentation Conforms to the CTD Structure and GCC Guidelines (Ministerial Resolution No. 113 of 2020) for Successful KDFC Product and Manufacturer Registration.
ValiPro provides expert Process Validation services tailored to meet the strict GMP and technical dossier requirements enforced by the DGPA&DC for foreign manufacturers supplying the Omani market. The regulations demand high-quality, verifiable documentation structured according to international standards.
Key compliance pillars for market access in Oman include:
National Authority (DGPA&DC/MoH): Responsible for registering manufacturers, local agents, and all pharmaceutical products before market entry. The registration is typically valid for five years and is subject to renewal.
Dossier Format (CTD): Product registration files must conform to the internationally accepted Common Technical Document (CTD) structure.
Manufacturing Standard (International GMP): Manufacturers must hold a legalized Valid Good Manufacturing Practice (GMP) Certificate from a recognized Health Authority in the country of origin. Oman follows WHO-GMP and recognizes certificates from Stringent Regulatory Authorities (SRAs).
Validation Requirement: Oman's regulations explicitly require documentation on the validation of both the manufacturing process and analytical procedures within the Quality Module (Module 3).
🌟 Why Validation is Crucial for DGPA&DC Compliance
Validation is a specific, required technical submission within the CTD dossier (Module 3), which the DGPA&DC assesses scientifically. Non-compliance or lack of detail in this area can lead to registration delays or rejection.
1. Mandatory Submission in CTD Module 3 (Quality)
The DGPA&DC requires a full CTD submission, where detailed validation data must be provided in Module 3 (Quality):
Module 3.2.P.3 (Manufacturing Process and Process Controls): This section requires a detailed description of the manufacturing process, identification of critical steps, and a summary of the Process Validation (PV) studies. The PV must prove the commercial-scale process consistently produces product meeting specifications.
Module 3.2.P.5 (Control of Finished Product): This section, and the corresponding section for the Drug Substance (3.2.S.4), requires detailed submission of the Analytical Procedures and the Validation of Analytical Procedures (AMV).
2. Good Manufacturing Practice (GMP) Verification
The Ministry of Health's inspection arm ensures the manufacturing site operates under a validated Quality Management System:
GMP Requirement: The foundation of the registration process is the provision of a valid GMP certificate. GMP guidelines (based on WHO and international standards) state that critical steps of manufacturing processes and significant changes to the process must be validated.
Qualification (IQ/OQ/PQ): Compliance with GMP requires that all critical equipment, utilities (e.g., HVAC, Water Systems), and facilities are fully Qualified (IQ, OQ, PQ).
Post-Market Surveillance: The Ministry of Health regularly collects samples of registered drugs to verify that they continue to comply with technical specifications submitted at the time of registration, providing an ongoing verification of the validated state of the manufacturing process.
3. Change Control and Compliance
Omani regulations strictly control changes to registered products:
Approval for Changes: The Regulations expressly stipulate that no changes may be made to the... manufacturing method of the registered drug without prior consent from the Ministry. Any significant change to a validated process requires a corresponding post-change validation and regulatory submission (Variation).
🎯 Compliance Focus: Who We Support
We work with foreign manufacturers targeting the Omani market:
International Exporters: Assisting in compiling robust CTD Module 3 documentation, ensuring the validation data meets the scientific and technical scrutiny of the DGPA&DC.
Generic Drug Applicants: Providing fully compliant Process Validation and Analytical Method Validation data, in line with ICH Q2(R1), to support the quality and any Bioequivalence claims in the dossier.
Manufacturers Seeking GCC Registration: Aligning validation programs with the unified standards of the Gulf Health Council (GHC).
🛠️ Our Process Validation Services for DGPA&DC Compliance
We provide complete, scientifically sound, and internationally accepted validation documentation ready for DGPA&DC submission.
ServiceDGPA&DC / GCC / CTD FocusCTD Module 3 CompilationStructuring and writing the validation summaries for inclusion in the specific sections of CTD Module 3 (Quality), explicitly covering 3.2.P.3 and 3.2.P.5.ICH Process ValidationDevelopment of Process Performance Qualification (PPQ) protocols and reports for critical manufacturing steps, in line with global standards.Analytical Method Validation (AMV)Execution and reporting of Method Validation studies (ICH Q2 principles) for all QC tests, including those used in Bioequivalence studies.Qualification & Cleaning ValidationDocumentation to support the Qualification (IQ/OQ/PQ) of critical equipment and Cleaning Validation protocols to demonstrate comprehensive GMP compliance.
🤝 Next Step: Secure DGPA&DC Validation Readiness
Ensure your validation documentation is robust, aligned with the mandatory CTD format, and ready to support your product and manufacturer registration in Oman.
To receive a Technical Scope and Commercial Proposal tailored for your Oman 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 DGPA&DC