🇧🇳 ValiPro: BDMCA (Brunei) ASEAN/PIC/S GMP Validation Services
Ensure Validation Documentation Meets ASEAN Common Technical Dossier (ACTD) Requirements for BDMCA Registration and Supports Recognized GMP Certification.
ValiPro provides expert Process Validation services specifically tailored to meet the strict Good Manufacturing Practice (GMP) requirements enforced by the BDMCA for foreign manufacturers supplying the Brunei market.
Key compliance pillars for market access in Brunei include:
National Authority (BDMCA/DPS): Responsible for registration, licensing, and enforcing quality standards for medicinal products.
Dossier Standard (ACTD): Product registration applications must be submitted in line with the ASEAN Common Technical Dossier (ACTD) format.
Manufacturing Standard (PIC/S/ASEAN GMP): Compliance with internationally recognized GMP standards is mandatory, particularly the PIC/S Guide to GMP (as adopted by ASEAN).
Regulatory Reliance: The registration process is significantly facilitated for products already registered in benchmark regulatory agencies such as Australia, Canada, EU (centralized), Malaysia, Singapore, United Kingdom, and the United States of America.
🌟 Why Validation is Crucial for BDMCA Compliance
Validation is the technical proof of quality and process consistency, which is reviewed by the Drug Registration Unit (DRU) of the DPS and confirmed via GMP certification.
1. Dossier Submission via ACTD (Part II: Quality)
The required documentation for medicinal product registration follows the ASEAN Common Technical Dossier (ACTD) format, which has four parts. Validation evidence is contained within Part II: Quality (CMC).
ACTD Part II Requirements: This section requires comprehensive details on the manufacturing process, process control, and validation studies. The BDMCA requires the manufacturing process to be fully described and substantiated by validation data.
Process Validation Summary: This section must include a summary of the validation (or process evaluation) studies for the final product and sterilization process, proving that the manufacturing process is robust and consistently yields a product meeting all specifications.
2. Analytical Method Validation (AMV)
Reliable quality control is a core requirement, especially for generic drugs:
ICH Q2 Compliance: All analytical test methods used to ensure the identity, strength, quality, purity, and potency of the drug substance and drug product must be validated according to global standards, such as those laid out in ICH Q2(R1).
Bioequivalence (BE) Studies: For generic products, submission of acceptable Bioequivalence data is often required. The analytical testing for the BE study must be performed using fully validated bioanalytical methods.
3. GMP Certification and Inspection Acceptance
The BDMCA relies heavily on the GMP inspection status of the manufacturing site:
Accepted GMP Authorities: The BDMCA will accept GMP certificates and/or inspection reports from recognized regulatory authorities (including those covered under the ASEAN Sectoral Mutual Recognition Arrangement for GMP Inspection), provided the manufacturing facility conforms to the applicable standards, often defined as the PIC/S Guide to GMP.
Foreign Site Compliance: A manufacturer supplying Brunei must ensure their entire quality system, including their Validation Master Plan (VMP), equipment Qualification (IQ/OQ/PQ), and Cleaning Validation, aligns with the expected PIC/S/WHO GMP level.
🎯 Compliance Focus: Who We Support
We work with manufacturers targeting the Brunei market:
ASEAN Region Manufacturers: Assisting companies to optimize their validation documentation to meet the unified ACTD and ASEAN GMP requirements.
International Exporters: Providing technical validation summaries to support the Product Licence Application and comply with the high standards expected from benchmark regulatory agencies.
Generic Drug Applicants: Ensuring that all Process Validation and Analytical Method Validation data is robust and suitable for review by the BDMCA.
🛠️ Our Process Validation Services for BDMCA Compliance
We provide complete, scientifically sound, and internationally accepted validation documentation ready for BDMCA submission.
ServiceBDMCA / ACTD / PIC/S FocusACTD Part II CompilationStructuring and writing the validation summaries for inclusion in the Quality Module (Part II) of the ACTD dossier.ICH/PIC/S Process ValidationDevelopment of Process Performance Qualification (PPQ) protocols and reports aligned with the PIC/S Guide to GMP.Analytical Method Validation (AMV)Execution and reporting of Method Validation studies (ICH Q2 principles) for all QC tests.Aseptic ValidationSpecialized validation for sterile manufacturers, including Aseptic Process Simulation (Media Fills), aligning with global standards.
🤝 Next Step: Secure BDMCA Product Registration
Ensure your validation documentation is robust, structured according to the ACTD, and is ready to support your product registration in Brunei Darussalam.
To receive a Technical Scope and Commercial Proposal tailored for your Brunei project, simply provide:
Product: Active Pharmaceutical Ingredient (API) or Finished Formulation
Dossier Format: ACTD / CTD (if applying via a reference country)
Current GMP Certification: (e.g., PIC/S, EU GMP, WHO GMP)
Timeline: Target submission date for the BDMCA