GlobalCOA – Zimbabwe (Republic of Zimbabwe) 🇿🇼

Certificate of Analysis (COA) Preparation, Review & Testing Services

Zimbabwean-Compliant COAs. Regulatory-Ready. Export-Focused.

GlobalCOA provides end-to-end Certificate of Analysis (COA) preparation, review, and testing services tailored to the dual regulatory requirements of the Medicines Control Authority of Zimbabwe (MCAZ) and the Standards Association of Zimbabwe (SAZ).

The COA is a core technical document that is essential for Product Registration with MCAZ and a mandatory technical input for the Consignment-Based Conformity Assessment (CBCA) program for general imports.

🏛️ Regulatory Framework – Zimbabwe

Zimbabwe's import control system is characterized by stringent control over medicines and a mandatory pre-export inspection program for a wide range of regulated goods.

1. Medicines Control Authority of Zimbabwe (MCAZ)

The MCAZ regulates and controls the sale, advertising, manufacture, possession, and safe custody of Medicines, Allied Substances, and Medical Devices. The COA is mandatory for:

• Product Registration/Market Authorization (MA): Applications for conventional medicines involve the submission of a dossier in the Common Technical Document (CTD) format.

  • The COA (Certificate of Analysis) is a critical document within the Quality Module (Module 3) of the dossier, certifying the identity, purity, and potency of the drug substance (API) and the finished product.

• Import/Export Licence: An Import Licence is required for controlled goods, including medicines. While not always listed as a direct requirement for the license application, the COA is vital for the physical examination and verification carried out by MCAZ regulatory officers upon arrival at the port of entry.

  • MCAZ operates a Quality Control Testing program to ensure compliance with the quality specifications claimed in the COA.

2. Standards Association of Zimbabwe (SAZ) – CBCA Program

The Standards Association of Zimbabwe (SAZ) implements the mandatory Consignment-Based Conformity Assessment (CBCA) Programme (which is Zimbabwe's version of a Pre-Export Verification of Conformity, or PVoC) for regulated products.

• Certificate of Conformity (CoC): All regulated products imported into Zimbabwe must be assessed before shipment and be accompanied by a Certificate of Conformity (CoC) issued by an authorized CBCA Service Provider (e.g., SAZ, Bureau Veritas, Cotecna).

• Role of the COA/Test Report: The COA is the primary technical document used during the CBCA process:

  • Documentary Review: The CBCA Service Provider reviews the COA (or valid test reports from an ISO 17025 accredited laboratory) to verify the product's compliance with applicable Zimbabwean Standards (ZS) or approved international standards.

  • Non-Compliance: Consignments arriving without the required CoC are subject to Destination Inspection by SAZ, which can lead to significant delays, inspection fees, or refusal of entry.

• Import Licenses for Controlled Goods: The Ministry of Industry and Commerce controls certain imports (e.g., certain foods, chemicals) via Statutory Instruments. For these goods, the COA supports the application for the Import Licence by providing proof of quality and safety.

🔬 Our GlobalCOA Services – Zimbabwe

We specialize in preparing COAs that meet the combined, stringent requirements of both MCAZ and the SAZ CBCA program.

✅ COA Preparation (Zimbabwean-Compliant)

• COA drafting and formatting aligned with MCAZ's CTD quality module requirements for drug registration.

• Test parameters and acceptance criteria are strictly aligned with Pharmacopeial standards (for MCAZ) and relevant Zimbabwean Standards (ZS) (for SAZ/CBCA).

• Ensuring the COA is fully compliant for submission to the CBCA Service Provider to secure the mandatory CoC.

✅ COA Review & Regulatory Compliance Assessment

• Review of existing COAs to verify compliance with MCAZ's dossier checklist (API and FPP COAs).

• Verification that the COA is robust and issued by an ISO 17025 accredited laboratory to satisfy the CBCA program's documentary review requirements.

✅ Testing & Analytical Coordination (Zimbabwe)

• Coordination of accredited laboratory testing to generate the comprehensive COA/Test Report required for the CBCA Programme.

• Method selection based on Pharmacopeial methods (BP, USP, EP) for drugs and Zimbabwean Standards (ZS) / Codex Alimentarius for food and general products.

📦 Product Categories Covered – Zimbabwe

GlobalCOA provides COA services for all regulated sectors:

• 🔹 MCAZ Regulated: Pharmaceuticals, APIs, Allied Substances, and Medical Devices.

• 🔹 SAZ CBCA Regulated: A wide range of products including food, automotive spares, electricals, and general consumer goods.

• 🔹 Ministry of Commerce Regulated: Goods requiring special Import Licences (e.g., certain chemicals, agricultural products).

🌟 Why Choose GlobalCOA for Zimbabwe?

• ✔ MCAZ CTD Expertise: Ensuring the COA is correctly presented for the regulatory assessment of health products.

• ✔ CBCA/CoC Assurance: Providing the necessary accredited COAs/Test Reports to secure the mandatory Certificate of Conformity (CoC) before shipment, avoiding costly destination inspection penalties.

• ✔ Quality Compliance: Supporting ZIMRA customs clearance by demonstrating verifiable product quality and conformity with national standards.

📝 Regulatory & Export Support – Zimbabwe

GlobalCOA COAs are engineered to support critical import milestones:

• MCAZ Product Registration Dossier submission (MA issuance).

• Obtaining the mandatory Certificate of Conformity (CoC) via the SAZ CBCA program.

• Customs Clearance against the submitted CoC and the necessary Import Licences.

Our Zimbabwe-focused COAs ensure products meet national quality benchmarks, minimizing the risk of seizure or rejection.

📞 Get Started with GlobalCOA – Zimbabwe

Whether you are registering medicines with MCAZ or exporting CBCA-regulated goods, GlobalCOA by Zoesoe Exports Pvt Ltd is your trusted compliance partner.