GlobalCOA – Hong Kong SAR 🇭🇰
Certificate of Analysis (COA) Preparation, Review & Testing Services
Hong Kong-Compliant COAs. Regulatory-Ready. Export-Focused.
GlobalCOA, a professional service brand of Zoesoe Exports Pvt Ltd, provides end-to-end Certificate of Analysis (COA) preparation, review, and testing services in accordance with Hong Kong Special Administrative Region (SAR) requirements for products manufactured, marketed, or exported from Hong Kong.
We support Hong Kong manufacturers, exporters, traders, and brand owners with accurate, compliant, and authority-acceptable COAs, ensuring full compliance with local ordinances and seamless acceptance in domestic and international markets.
🏛️ Regulatory Framework – Hong Kong SAR
Hong Kong's regulatory framework heavily relies on ordinances and often references major international standards, given its free trade economy and regulatory system.
Department of Health (DH) / Drug Office: Regulates Pharmaceutical Products (Drugs), Proprietary Chinese Medicines (PCMs), and associated raw materials under the Pharmacy and Poisons Ordinance (Cap. 138) and Chinese Medicine Ordinance (Cap. 549).
Food and Environmental Hygiene Department (FEHD) / Centre for Food Safety (CFS): Enforces food safety standards under the Public Health and Municipal Services Ordinance (Cap. 132) and various subsidiary regulations.
Hong Kong Accreditation Service (HKAS): The official body for accrediting conformity assessment bodies, including testing laboratories, under the Hong Kong Laboratory Accreditation Scheme (HOKLAS) (ISO/IEC 17025).
International Standards: Due to the absence of a dedicated national standards body like in other countries, the regulatory system highly references:
BP / USP / EP / Ph. Int.: For Western Pharmaceuticals and related raw materials.
WHO / ICH / PIC/S: Guidelines for manufacturing and quality.
Codex Alimentarius: For food and health supplements.
🔬 Our GlobalCOA Services – Hong Kong SAR
We offer complete lifecycle support for Certificate of Analysis documentation as per Hong Kong SAR expectations:
✅ COA Preparation (HK-Compliant)
COA drafting aligned with Drug Office/DH requirements for Western and Chinese Medicines, and CFS/FEHD standards for Food.
Alignment with referenced international pharmacopoeias (USP / BP / EP) and global best practices for quality documentation.
Batch-wise, stability-based, and customer-specific COAs, suitable for Product Registration (DH) and trading documentation.
✅ COA Review & Regulatory Compliance Assessment
Review of existing COAs for compliance with the Pharmacy and Poisons Ordinance, Chinese Medicine Ordinance, and Food Safety Ordinances.
Identification and correction of:
Missing mandatory testing parameters (e.g., heavy metals for PCMs/Food, specific active content).
Incorrect acceptance criteria (e.g., failure to meet pharmacopoeial limits).
Harmonization with product specifications and registration dossiers submitted to the DH.
✅ Testing & Analytical Coordination (Hong Kong)
Testing coordination through HOKLAS-accredited (ISO/IEC 17025) or internationally recognized laboratories, often used by the local trade.
Method selection as per:
Relevant Pharmacopoeial methods (BP, USP, CP, EP).
Validated in-house methods with appropriate justification.
Methods aligned with Codex / WHO guidelines for food and other products.
Support for re-testing, OOS/OOT investigations, and quality trend analysis.
📦 Product Categories Covered – Hong Kong SAR
GlobalCOA provides COA services for regulated sectors:
🔹 Pharmaceutical Products (Western Medicine)
APIs, finished drug products, and raw materials (regulated by DH Drug Office).
🔹 Proprietary Chinese Medicines (PCMs)
Finished products and associated raw herbs/materials (regulated by DH Chinese Medicine Office).
🔹 Food, Health Supplements & Beverages
Products regulated under the CFS/FEHD (often requiring testing for contaminants, heavy metals, microbial load).
🔹 Cosmetics & Personal Care
Products often checked against international standards for safety and prohibited substances.
🏭 Industries We Serve – Hong Kong SAR
GlobalCOA supports regulated Hong Kong industries including:
Pharmaceutical Trading and Manufacturing
Proprietary Chinese Medicine (PCM) Manufacturers
Food & Health Supplement Importers/Exporters
Cosmetics and Personal Care Product Trading Houses
🌟 Why Choose GlobalCOA for Hong Kong SAR?
✔ Deep understanding of DH and CFS requirements and reliance on international standards.
✔ COAs aligned with major Pharmacopoeias (BP/USP) and Codex standards.
✔ Strong coordination with HOKLAS-accredited laboratories.
✔ Highly accepted export documentation for global trade.
📝 Regulatory & Export Support – Hong Kong SAR
GlobalCOA COAs support critical processes in the Hong Kong context:
Product Registration applications for Western Drugs and PCMs (DH).
Customs Clearance and trade documentation requirements.
Compliance with Food Safety Ordinances for local sale.
Supporting documentation for GMP/GSP compliance and quality audits.
Our Hong Kong-focused COAs ensure regulatory acceptability and facilitate efficient international trade.
📞 Get Started with GlobalCOA – Hong Kong SAR
Whether you require new COA preparation, review of existing COAs, or testing support for Hong Kong manufacturing or export batches, GlobalCOA by Zoesoe Exports Pvt Ltd is your trusted compliance partner.