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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 emphasise their relationships and their fundamental importance to the production and control of medicinal products.
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Resmi Gazete Dışındaki Kaynak
Kurum: Türkiye İlaç ve Tıbbi Cihaz Kurumu (TİTCK)
Yürürlüğe Giriş Tarihi: 09.02.2017
Bu Sürümün Yürürlük Tarihi: 01.10.2017 - 01.10.2017
Kurum: Türkiye İlaç ve Tıbbi Cihaz Kurumu (TİTCK)
Yürürlüğe Giriş Tarihi: 09.02.2017
Bu Sürümün Yürürlük Tarihi: 01.10.2017 - 01.10.2017
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PART 1
BASIC REQUIREMENTS FOR HUMAN MEDICINAL PRODUCTS
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 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 Responsible person.
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 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;
iv. arrangements are made for the manufacture, supply and use of the correct starting and packaging materials;
v. all necessary controls on intermediate products, and any other inprocess controls and validations are carried out;
vi. the finished product is correctly processed and checked, according to the defined procedures;
vii. medicinal products are not sold or supplied before the Responsible 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 release of medicinal products;
viii. satisfactory arrangements exist to ensure, as far as possible, that the medicinal products are stored, distributed and subsequently handled so that quality is maintained throughout their shelf life;
ix. there is a procedure for self-inspection and/or quality audit, which regularly appraises 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 Medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use 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 processes 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;
ii. critical steps of manufacturing processes and significant changes to the process are validated;
iii. all necessary facilities for GMP are provided including:
a. appropriately qualified and trained personnel;
b. adequate premises and space;
c. suitable equipment and services;
d. correct materials, containers and labels;
e. approved procedures and instructions;
f. 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;