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The Rules Governing Medicinal Products in the European Union
Volume 4
EU Guidelines to
Good Manufacturing Practice
Medicinal Products for Human and Veterinary U
Part I
Chapter 1 Quality Management
Principle
The holder of a Manufacturing Authorisation must manufacture medicinal products so as to ensure that they are fit for their intended u, comply with the requirements of the Mark
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eting 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 nior 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, Quality Control and Quality Risk Management. It should be fully documented and its effectiveness monitored. All parts of the Quality Assurance system should be adequately resourced with competent personnel, and suitable and sufficient premis, equipment and facilities. There are additional legal responsibilities for the holder of the Manufacturing Authorisation and for the Qualified Person(s).
The basic concepts of Quality Assurance, Good Manufacturing Practice, Quality Control and Quality Risk Management are inter-related. They are described here in order to emphasi 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, which covers all matters, which individually or collectively influence the quality of a product. It is the sum total of the organid arrangements made with the objective of ensuring that medicinal products are of the quality required for their intended u. 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;
物质基础决定上层建筑(ii) production and control operations are clearly specified and Good Manufacturing Practice adopted;
(iii) managerial responsibilities are clearly specified;
(iv) arrangements are made for the manufacture, supply and u of the correct starting and packaging materials;
(v) all necessary controls on intermediate products, and any other in-process controls and validations are carried out;
(vi) the finished product is correctly procesd and checked, according to the defined procedures;
(vii) medicinal products are not sold or supplied before a Qualified Person has certified that each production batch has been produced and controlled in accordance with the requirements of the Marketing Authorisation and any other regulations relevant to the production, control and relea of medicinal products;
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(viii) satisfactory arrangements exist to ensure, as far as possible, that the medicinal products are stored, distributed and subquently handled so that quality is maintained throughout their shelf life;
(ix) there is a procedure for Self-Inspection and/or quality audit, which regularly apprais the effectiveness and applicability of the Quality Assurance system.
Good Manufacturing Practice for Medicinal Products (GMP)
1.2 Good Manufacturing Practice is that part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended u and as required by the Marketing Authorisation or product specification.
Good Manufacturing Practice is concerned with both production and quality control. The basic requirements of GMP are that:
(i) all manufacturing process are clearly defined, systematically reviewed in the light of experience and shown to be capable of consistently manufacturing medicinal products of the required quality and complying with their specifications;
冷风过境(ii) critical steps of manufacturing process and significant changes to the process are v
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(iii) all necessary facilities for GMP are provided including:
• appropriately qualified and trained personnel;
• adequate premis and space;
• suitable equipment and rvices;
朵的笔顺怎么写• correct materials, containers and labels;
• approved procedures and instructions;
• suitable storage and transport;
(iv) instructions and procedures are written in an instructional form in clear and unambiguous language, specifically applicable to the facilities provided;
(v) operators are trained to carry out procedures correctly;
