GlobalCOA – Zambia (Republic of Zambia) 🇿🇲
Certificate of Analysis (COA) Preparation, Review & Testing Services
Zambian-Compliant COAs. Regulatory-Ready. Export-Focused.
GlobalCOA provides end-to-end Certificate of Analysis (COA) preparation, review, and testing services tailored to the mandatory requirements of the Zambia Medicines Regulatory Authority (ZAMRA) and the Zambia Compulsory Standards Agency (ZCSA).
The COA is a core technical document essential for product registration for health products and for demonstrating compliance during the Import Quality Monitoring process for a wide range of regulated goods.
🏛️ Regulatory Framework – Zambia
Zambia's quality control is enforced by specialized bodies, with the COA providing the necessary technical proof for compliance and clearance.
1. Zambia Medicines Regulatory Authority (ZAMRA)
ZAMRA regulates and controls the manufacture, importation, distribution, and sale of Medicines, Allied Substances (like disinfectants, food supplements, and feed additives), Medical Devices, and Cosmetics. The COA is mandatory at the product registration phase:
Product Registration/Marketing Authorization (MA): ZAMRA requires the submission of a dossier in the Common Technical Document (CTD) format. The COA is a critical part of the quality information:
Pharmaceuticals: The dossier must include the Certificate of Analysis (COA) for the Active Pharmaceutical Ingredient (API) and the COA for the Finished Pharmaceutical Product (FPP) (often for the batches used in stability studies).
Cosmetics & Food Supplements: Registration requires an accompanying dossier which often includes a quality analysis/inventory list demonstrating compliance with claimed specifications and relevant standards (e.g., ISO 22715 for cosmetics).
Quality Surveillance: ZAMRA's National Drug Quality Control Laboratory (NDQCL) will analyze samples of imported products against the specifications provided in the manufacturer's COA. The COA must, therefore, be accurate and compliant with the claimed pharmacopoeia (e.g., BP, USP) or standard.
Import Permits: ZAMRA issues permits for controlled goods, and the COA supports the technical assessment for these permits.
2. Zambia Compulsory Standards Agency (ZCSA)
The Zambia Compulsory Standards Agency (ZCSA) (formerly the Zambia Bureau of Standards - ZABS) administers and monitors the quality and safety of products covered under the Compulsory Standards Act through its Import Quality Monitoring Scheme.
Compulsory Standards: ZCSA administers around 60 compulsory standards, which cover critical products like certain foods, consumer goods, and construction materials.
Import Clearance Schemes: Importers use various schemes (Batch Import Clearance, Pre-Import Scheme, Annual Import Quality Certification Scheme) for quality monitoring. In all cases, the COA is vital:
Inspection and Testing: ZCSA relies on Test Certificates from foreign laboratories (COAs) provided the laboratories are accredited (e.g., ISO 17025 or SADCAS-accredited). The COA must show that the product complies with the relevant Uganda Standard (US), international standard (Codex Alimentarius, ISO, ASTM), or the client's specifications.
Failure to provide a compliant COA or non-compliance after physical inspection can lead to sampling, testing, delays, or rejection.
🔬 Our GlobalCOA Services – Zambia
We specialize in producing COAs that satisfy the stringent regulatory scrutiny of ZAMRA and the technical verification required by ZCSA for imports.
✅ COA Preparation (Zambian-Compliant)
COA drafting and formatting aligned with ZAMRA's CTD quality module requirements for drug registration and cosmetics/supplements.
Test parameters and acceptance criteria are strictly aligned with Pharmacopeial standards (for ZAMRA) and relevant Zambian/International Standards (for ZCSA regulated products).
Ensuring the COA details (Batch No., Dates, Analyst credentials) are consistent and traceable.
✅ COA Review & Regulatory Compliance Assessment
Review of existing COAs to verify compliance with ZAMRA's registration dossier checklist (e.g., COAs for API and FPP).
Verification that the COA is from an ISO 17025 accredited laboratory and covers all parameters required by the applicable Compulsory Standard for submission to ZCSA's Import Quality Monitoring Department.
✅ Testing & Analytical Coordination (Zambia)
Coordination of accredited laboratory testing to generate the comprehensive COA required for compliance with ZCSA standards.
Method selection based on Pharmacopeial methods (BP, USP, EP) for drugs and Uganda Standards (US) / Codex Alimentarius for food and general products.
📦 Product Categories Covered – Zambia
GlobalCOA provides COA services for regulated sectors:
🔹 ZAMRA Regulated: Pharmaceuticals, APIs, Veterinary Drugs, Medical Devices, Cosmetics, and Food Supplements.
🔹 ZCSA Regulated: Products covered by Compulsory Standards, including certain foods, electricals, and construction materials.
🌟 Why Choose GlobalCOA for Zambia?
✔ Expertise in the ZAMRA CTD Dossier: Ensuring the COA facilitates the smooth issuance of Marketing Authorization for health products.
✔ ZCSA Import Quality Monitoring: Providing the necessary accredited COAs/Test Reports to secure clearance under the Import Quality Monitoring Scheme, avoiding delays and rejections.
✔ Dual-Agency Compliance: Covering the distinct quality requirements of both the health and standards bodies.
📝 Regulatory & Export Support – Zambia
GlobalCOA COAs are engineered to support critical import milestones:
ZAMRA Product Registration Dossier submission (MA issuance).
Customs clearance and quality verification by ZCSA at the borders.
Supporting documentation for Permits for Controlled/Restricted Goods (e.g., pharmaceuticals, chemicals).
Our Zambia-focused COAs ensure products meet national quality benchmarks, preventing non-compliance issues.
📞 Get Started with GlobalCOA – Zambia
Whether you require new COA preparation, review of existing COAs, or testing support for batches destined for Zambia, GlobalCOA by Zoesoe Exports Pvt Ltd is your trusted compliance partner.