GlobalCOA – Malawi (Republic of Malawi) 🇲🇼

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

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

GlobalCOA provides end-to-end Certificate of Analysis (COA) preparation, review, and testing services in accordance with Malawian regulatory requirements for products manufactured, marketed, or exported to or from Malawi.

The COA is a critical quality document required for product registration, import permit issuance, and mandatory quality control monitoring for both health products and general consumer goods.

🏛️ Regulatory Framework – Malawi

Malawi's regulatory structure involves two principal authorities with stringent requirements for quality documentation:

• Pharmacy and Medicines Regulatory Authority (PMRA): The key authority responsible for regulating Medicines (Pharmaceuticals), Medical Devices, Cosmetics, and Allied Substances. The PMRA requires detailed COAs for:

  • Market Authorization (Product Licence) Dossiers: Dossiers must follow the Common Technical Document (CTD) format (or WHO TRS 970 Annex 4). The Quality Module (Module 3) requires COAs for both the Active Pharmaceutical Ingredient (API) and the Finished Product.

  • Import Permits/Consignment Clearance: COAs are mandatory for consignment clearance and for Investigational Medicinal Products (IMPs) for clinical trials, where the COA must accompany each batch. The PMRA conducts Port of Entry Inspection and relies on the COA for initial quality verification.

  • Quality Control: The PMRA's Quality Control Laboratory may sample and test imported products, using the manufacturer's COA as the benchmark.

• Malawi Bureau of Standards (MBS): The national body for standardization, metrology, and quality assurance. The MBS develops and implements Malawi Standards (MS) and oversees the Imports Quality Monitoring Scheme (IQMS). The COA is required for:

  • Import Commodity Clearance: Importers of designated products must apply for clearance from the MBS, which subjects shipments to sampling and testing. The application requires the original copy of any quality or test certificates (including results), which is the COA.

  • Pre-shipment Assessment: The MBS requires pre-shipment assessment (sending a sample with the COA to MBS for conformity assessment) for new products or products that previously failed conformity checks.

  • Certificate of Conformance (CoC): The MBS issues a Batch Certificate of Conformance or an Annual Import Quality Certificate based on satisfactory compliance, where the COA is the foundation of the quality evaluation.

🔬 Our GlobalCOA Services – Malawi

We focus on preparing COAs that satisfy the dual quality control requirements of the PMRA (for health products) and the MBS (for general imports).

✅ COA Preparation (Malawian-Compliant)

• COA drafting aligned with PMRA requirements (ICH CTD Module 3) for drug registration and mandatory MBS/IQMS specifications for general goods.

• Compliance with international pharmacopoeias (USP / BP / EP) for medicines and Codex Alimentarius / Malawi Standards (MS) for food and other regulated products.

• The COA must clearly state the Batch Number, Manufacturing Date, and Expiry Date and confirm compliance with the relevant Malawi Standard (MS) or the registered specification.

✅ COA Review & Regulatory Compliance Assessment

• Review of existing COAs for PMRA / MBS / MS compliance.

• Identification and correction of non-compliance issues:

  • Missing mandatory testing parameters (e.g., specific microbial or chemical limits defined in a Malawi Standard).

  • Discrepancies between the COA and the registered product specifications submitted to the PMRA.

• Verification for Import Clearance: Ensuring the COA/Test Report is suitable for the MBS's Import Commodity Clearance (IIRF application) and the PMRA's port inspection requirements.

✅ Testing & Analytical Coordination (Malawi)

• Testing coordination through ISO/IEC 17025 accredited laboratories recognized internationally and accepted by the PMRA and MBS.

• Method selection as per:

  • Relevant Pharmacopoeial methods (BP, USP, EP) for medicines.

  • Malawi Standards (MS) / Codex Alimentarius for food and other regulated products.

• Support for the required Pre-shipment testing and verification testing conducted by the MBS's Quality Control Laboratories.

📦 Product Categories Covered – Malawi

GlobalCOA provides COA services for regulated sectors:

• 🔹 Pharmaceuticals & Health Products: APIs, Finished Medicines, and Medical Devices (regulated by PMRA).

• 🔹 Food & Agriculture: Fertilizers (which require pre-shipment sample and COA submission to MBS), Food products, and Feed (regulated by MBS/relevant Ministries).

• 🔹 Industrial & Consumer Products: Goods subject to the mandatory MBS Imports Quality Monitoring Scheme (IQMS), including chemicals, textiles, and building materials.

🌟 Why Choose GlobalCOA for Malawi?

• **✔ Deep understanding of PMRA CTD format for drug quality and the MBS Import Quality Monitoring Scheme (IQMS) documentation.

• ✔ COAs aligned with mandatory Malawi Standards (MS) and essential for import permits and customs clearance.

• ✔ Documentation suitable for both Product Registration and the critical Consignment Clearance process.

📝 Regulatory & Export Support – Malawi

GlobalCOA COAs support critical processes in the Malawian context:

• Product Registration Dossiers to the PMRA (Quality Module).

• Import Commodity Clearance applications (IIRF) to the MBS.

• Customs clearance and quality verification by the MBS/PMRA at ports of entry.

Our Malawi-focused COAs ensure compliance with stringent quality verification procedures, minimizing the risk of consignment rejection or penalties.

📞 Get Started with GlobalCOA – Malawi

Whether you require new COA preparation, review of existing COAs, or testing support for batches destined for Malawi, GlobalCOA by Zoesoe Exports Pvt Ltd is your trusted compliance partner.