Good Manufacturing Practice (GMP) is that part of quality assurance which ensures that pharmaceutical products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by their marketing authorizations. It ensures that pharmaceutical products are manufactured so that they are fit for their intended use, comply with the requirements of the marketing authorizations and do not place the populace at risk.
The National Agency for Food and Drug Administration and Control (NAFDAC) ACT Cap N1, LFN 2004 empowers the Agency to control and regulate the manufacture, importation, exportation, distribution, advertisement, sale and use of its regulated products. This mandate requires that the Agency ensures the quality, safety, and efficacy of all regulated products. The Agency therefore has developed NAFDAC Good Manufacturing Practice Regulations which stipulate the minimum standards that manufacturers are required to adhere to ensure the quality of pharmaceutical products.
These guidelines are intended to help all stakeholders comply with the provisions of the NAFDAC Good Manufacturing Practice Regulations for pharmaceutical products. The regulations contain good manufacturing practice requirements for methods, facilities and controls for the manufacture, processing, packaging, or holding of a pharmaceutical product for human or animal use. The regulations are meant to ensure that pharmaceutical products meet the requirements of safety, quality and efficacy they purport or are represented to possess.
These guidelines apply to pharmaceutical, biological, and veterinary products as required by their marketing authorizations. They are also relevant for pharmaceutical manufacturing processes, such as those undertaken in hospitals.
These guidelines are not applicable to the compounding of a pharmaceutical product by a registered pharmacist in a government or private health institution in order to fill a prescription. The attainment of this quality objective is the responsibility of top management and requires the participation and commitment of all staff members in the different departments and at all levels within the organization as well as their suppliers.
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