NAFDAC Drug Evaluation & Research (DER) Directorate Good Cold Chain Management for Vaccines & Other Biopharmaceutical Products Guidelines 2019
Ministry of Health, National Agency for Food and Drug Administration and Control, Nigeria
Cold chain management is a specialized area of Biopharmaceutical products management that begins when a Biopharmaceutical product is manufactured, stored and moves through the distribution chain until it gets to the end-user at the time of administration. It is required that the product be held and distributed in a controlled environment. It is necessary to have adequate control of all steps and procedures involved both in manufacturing and quality control, storage and distribution, to ensure that product quality is maintained. Therefore, this document was designed to guide importers and owners of storage facilities for medicines that require cold chain management. This is to provide stakeholders with the relevant regulatory requirements needed to maintain the compliance status of their operational activities.
Process Flow
Department of Drug Evaluation and Research ⬤
Office of the Director General NAFDAC ⬤
Office of the Permanent Secretary, Ministry of Health ⬤
Office of the Minister of State for Health ⬤
Office of the Minister of Health ⬤
Federal Executive Council ⬤
NAFDAC Drug Evaluation & Research (DER) Directorate Good Cold Chain Management for Vaccines & Other Biopharmaceutical Products Guidelines 2019 Current Version
January 2022
Cold chain management is a specialized area of Biopharmaceutical products management that begins when a Biopharmaceutical product is manufactured, stored and moves through the distribution chain until it gets to the end-user at the time of administration. It is required that the product be held and distributed in a controlled environment. It is necessary to have adequate control of all steps and procedures involved both in manufacturing and quality control, storage and distribution, to ensure that product quality is maintained. Therefore, this document was designed to guide importers and owners of storage facilities for medicines that require cold chain management. This is to provide stakeholders with the relevant regulatory requirements needed to maintain the compliance status of their operational activities.
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