The holder of a Manufacturing License must manufacture traditional medicines and health supplements so as to ensure that they are fit for their intended use, comply with the requirements of the Product Registration and do not place patients or consumers at risk due to inadequate safety and quality. The attainment of this quality objective is the responsibility of senior management and requires the participation and commitment by staff in many different departments and at all levels within the company, by the company’s suppliers and by the distributors. To achieve the quality objective reliably there must be a comprehensively designed and correctly implemented system of Quality Assurance incorporating Good Manufacturing Practice and thus Quality Control. It should be fully documented and its effectiveness monitored. All parts of Quality Assurance system should be adequately resourced with competent personnel, and suitable and sufficient premises, equipment and facilities.
The basic concept of Quality Assurance, Good Manufacturing Practice and Quality Control are inter-related. They are described here in order to emphasise their relationships and their fundamental importance to the production and control of traditional medicines and health supplements.
Quality Assurance is a wide-ranging concept which covers all matters which individually or collectively influence the quality of a product. It is the sum total of the organized arrangements made with the object of ensuring the medicinal product are of the quality required for their intended use. Quality Assurance therefore incorporates Good Manufacturing Practice plus other factors outside the scope of this Guide.
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