CHAPTER 1 QUALITY MANAGEMENT The holder of a manufacturing authorisation must manufacture medicinal products so as to ensure that they are fit for trial intended use, comply with the requirements of the Marketing Authorisation and do not place patients at risk due to inadequate safety, quality or efficacy. 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 and Quality Risk Management. It should be fully documented and its effectiveness monitored. All parts of the Quality Assurance systems should be adequately resourced with competent personnel, and suitable and sufficient premises, equipment and facilities. There are additional legal responsibilities for the holder of the manufacturing authorisation and for the authorised person(s). The concepts of Quality Assurance, Good Manufacturing Practice, Quality Control and Quality Risk Management are inter-related. They are described here in order to emphasise their relationships and their fundamental importance to the production and control of medicinal products. QUALITY ASSURANCE 1.1 Quality Assurance is a wide-ranging concept, covers all matters, which individually or collectively influence the quality of a product. It is the sum total of the organised arrangements made with the objective of ensuring that medicinal products 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. The system of Quality Assurance appropriate for the manufacture of medicinal products should ensure that: i. medicinal products are designed and developed in a way that takes account of the requirements of Good Manufacturing Practice ; ii. production and control operations are clearly specified and Good Manufacturing Practice adopted; iii. managerial responsibilities are clearly specified;
CHAPTER 1 QUALITY MANAGEMENT The holder of a manufacturing authorisation must manufacture medicinal products so as to ensure that they are fit for intended use, comply with the requirements of the Marketing Authorisation and do not place patients at risk due to inadequate safety, quality or efficacy. 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 and Quality Risk Management. It should be fully documented and its effectiveness monitored. All parts of the Quality Assurance systems should be adequately resourced with competent personnel, and suitable and sufficient premises, equipment and facilities. There are additional legal responsibilities for the holder of the manufacturing authorisation and for the authorised person(s). The concepts of Quality Assurance, Good Manufacturing Practice, Quality Control and Quality Risk Management are inter-related. They are described here in order to emphasise their relationships and their fundamental importance to the production and control of medicinal products. QUALITY ASSURANCE 1.1 Quality Assurance is a wide-ranging concept, covers all matters, which individually or collectively influence the quality of a product. It is the sum total of the organised arrangements made with the objective of ensuring that medicinal products 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. The system of Quality Assurance appropriate for the manufacture of medicinal products should ensure that: i. medicinal products are designed and developed in a way that takes account of the requirements of Good Manufacturing Practice ; ii. production and control operations are clearly specified and Good Manufacturing Practice adopted; iii. managerial responsibilities are clearly specified; trial
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