Site master file что это
site master file
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Site Master File — or SMF is a document in the pharmaceutical industry which provides information about the production and control of manufacturing operations. The document is created by a manufacturer. References [http://www.tga.gov.au/docs/html/siteinfo.htm SMF:… … Wikipedia
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site master file
1 site master file
См. также в других словарях:
Site Master File — or SMF is a document in the pharmaceutical industry which provides information about the production and control of manufacturing operations. The document is created by a manufacturer. References [http://www.tga.gov.au/docs/html/siteinfo.htm SMF:… … Wikipedia
Drug Master File — or DMF is a document prepared by a pharmaceutical manufacturer and submitted solely at its discretion to the appropriate regulatory authority in the intended drug market. There is no regulatory requirement to file a DMF. However, the document… … Wikipedia
Master boot record — A master boot record (MBR) is a type of boot sector popularized by the IBM Personal Computer.[1] It consists of a sequence of 512 bytes located at the first sector of a data storage device such as a hard disk. MBRs are usually placed on storage… … Wikipedia
Site Mame (Tours) — 47° 23′ 36″ N 0° 40′ 09″ E / 47.393269, 0.669073 Le Site Mame est le site d une ent … Wikipédia en Français
Master Emerald — Sonic Cet article a pour sujet Sonic le hérisson. Pour une définition du mot « sonic », voir l’article sonic du Wiktionnaire. Sonic Légende <<
Mix Master Mike — Beastie Boys Beastie Boys Pays d’origine … Wikipédia en Français
The Master Genealogist — Original author(s) Bob Velke Developer(s) Wholly Genes Software Initial release 1991 Stable release 7.04.000 / February 13, 2009; 2 years ago (2009 02 1 … Wikipedia
Flexible single master operation — Flexible Single Master Operations (FSMO, F is sometimes floating ; pronounced Fiz mo), or just single master operation or operations master, is a feature of Microsoft s Active Directory (AD).[1] As of 2005, the term FSMO has been deprecated… … Wikipedia
The Ipcress File (film) — Infobox Film | name =The IPCRESS File caption =original movie poster director = Sidney J. Furie producer = Harry Saltzman writer =Len Deighton (novel) Bill Canaway James Doran starring =Michael Caine Nigel Green Guy Doleman Sue Lloyd Gordon… … Wikipedia
Sully Historic Site — Sully Historic Site, more commonly known as Sully Plantation is in Chantilly, Virginia. The main house was built 1794 1799 by Richard Bland Lee. He was Northern Virginia s first Representative to Congress in 1789, as well as an uncle of Robert E … Wikipedia
Приложение 2 к Методическим указаниям МУ 64-04-002-2002. Производство лекарственных средств.
ИНФОРМАЦИЯ О ПРЕДПРИЯТИИ (SITE MASTER FILE). СОДЕРЖАНИЕ ДОКУМЕНТА
1. Общая информация
1.1. Краткая информация о предприятии (включая название и адрес), отношение к другим участкам и особенно любая информация, относящаяся к пониманию производственных операций.
1.2. Деятельность по производству фармацевтической продукции, лицензированная национальным уполномоченным органом.
1.3. Любая другая производственная деятельность, осуществляемая на участке.
1.4. Название и точный адрес предприятия (участка), включая телефон, факс и номера телефонов, работающих круглосуточно.
1.5. Перечень продукции, фактически производимой на участке (приложение), и информация о любых особо токсичных или опасных веществах, используемых в работе, со ссылкой на способ их производства (с использованием специально предназначенных технических средств или на основании принципа проведения кампаний).
1.6. Краткое описание производственного участка (размер, расположение, непосредственно окружающая его среда и другая производственная деятельность на участке).
1.7. Количество сотрудников, занятых в производстве, контроле качества, хранении и распределении (оптовой реализации).
1.8. Использование посторонней научной, аналитической или другой технической помощи, относящейся к производству и анализу.
1.9. Краткое описание системы управления качеством предприятия.
2.1. Организационная схема, в которой перечислены мероприятия по обеспечению качества, включая производство и контроль качества.
2.2. Квалификация, опыт и обязанности руководящего персонала.
2.3. Описание в общих чертах мероприятий по основному обучению и обучению на местах, по ведению протоколов.
2.4. Требования к здоровью персонала, занятого в производстве.
2.5. Гигиенические требования к персоналу, в частности к одежде.
3. Помещения и оборудование
3.1. Простой план с указанием масштаба (архитектурные или инженерные чертежи не требуются) или описание производственных зон.
3.2. Тип конструкций и отделки производственных помещений.
3.3. Краткое описание вентиляционных систем. Подробно описать критические зоны с потенциальным риском контаминации с потоком воздуха (приложить схематические чертежи систем). Указать классификацию «чистых» помещений и зон.
3.4. Специальные зоны для работы с высокотоксичными, опасными и сенсибилизирующими веществами.
3.5. Краткое описание систем водоснабжения (желательно приложить схематические чертежи систем). Подробно описать системы специального водоснабжения, включая санитарную обработку (подготовка воды очищенной, для инъекций и др.) с приложением схем.
3.6. Краткое описание систем подготовки и распределения сжатого воздуха, пара, инертных газов и др.
3.7. Краткое описание основного технологического оборудования и оборудования контрольных лабораторий (перечень оборудования не требуется).
3.8. Техническое обслуживание технологического и лабораторного оборудования, инженерных систем, помещений (программы планируемого профилактического обслуживания и системы его протоколирования).
3.9. Поверка или калибровка средств измерений, включая систему протоколирования. Мероприятия по валидации компьютеризированных систем.
3.10. Спецификации технологического и лабораторного оборудования и методик по очистке производственных зон и оборудования (перечень или ссылка на перечень).
4.1. Система документации предприятия. Мероприятия по подготовке, пересмотру и распределению необходимой для производства документации.
4.2. Любая другая документация, относящаяся к качеству препарата, которая больше нигде не упоминается (например, микробиологический контроль воздуха и воды).
5. Технологический процесс
5.2. Мероприятия по работе с исходным сырьем, упаковочными материалами, не расфасованной и готовой продукцией, включая отбор проб, карантин и хранение.
5.3. Мероприятия по работе с забракованным сырьем или продукцией.
5.4. Краткое описание общей политики относительно валидации процессов.
6. Контроль качества
6.1. Описание системы контроля качества и деятельности отдела контроля качества.
6.2. Порядок выдачи разрешения на реализацию готовой продукции.
7. Производство и анализ по договору (контракту)
7.1. Описание способа оценки исполнителя на соответствие GMP.
8. Оптовая реализация, рекламации и отзыв продукции
8.1. Перечень СОПов по оптовой реализации и система протоколирования.
8.2. Перечень СОПов по работе с рекламациями (жалобами) и отзыву продукции.
9.1. Краткое описание системы самоинспекции.
Примечание: Информация о предприятии (site master file) не должна превышать 30 страниц формата А4.
Site master file что это
Here you will find answers to the following questions:
15.E.1 Introduction
The site master file provides a general company description with regard to the implementation of valid GMP Guidelines within this company. The contents of each chapter are aligned with the associated chapters of the EU GMP Guideline.
Article 2 of the agreement for mutually recognised inspections (PIC) concerning the manufacture of pharmaceutical products states the following: If a pharmaceutical product is to be introduced into a contracting state which is different to the contracting state in which it was manufactured, the authorities in the country of manufacture can issue information in the form of a report to the country in which the product will be introduced.
This report comprises three sections.
The site master file has its counterpart in the form of the Plant Master File.
15.E.2 Design
The information required should not exceed a quantity of 25 to 30 DIN A4 pages in total; this information and further details on the maximum number of pages for each chapter is contained in the PIC document.
The site master file should be updated at regular intervals (every two years). Each of the individually numbered DIN A4 pages should have an issue number (version) and bear the date of its implementation. Each of the nine chapters must begin on a new sheet, so that the contents can be updated and the relevant pages replaced. Figure 15.E-1 contains an overview of the chapters in the site master file.
Figure 15.E-1 Structure of the site master file
Structure of the site master file
Premises and equipment
Contract manufacturing and analysis
Distribution, complaints and product recalls
List of all manufactured products
Each chapter is described in more detail in the following text.
15.E.2.1 General information
This chapter contains the «data sheet» style description of the company with its name, postal address and telephone/fax number. This information is rounded off with a brief illustration/description of the company, e.g. details on areas of research and development, number of employees world-wide, production, research and development locations world-wide.
The pharmaceutical (human/veterinary) manufacturing activities are then set out in accordance with the permit issued by the competent authority. To this end, the associated products are named together with information on which manufacturing step (manufacture, packaging, analysis, storage) is carried out in which facility.
Particular attention must be paid when listing toxic and dangerous materials (e.g. antibiotics, hormones, zytostatics).
Such conditions and/or limitations should be listed in the permit certificate.
Non-pharmaceutical products (such as cosmetics, dietary supplements, reagents) must also be listed.
Finally, details on professional and technical support are also required. Information regarding the extent to which scientific, analytical or other technical support from a third party company is used during manufacture or analysis is also required. The contractual partners must be listed with their name/address and telephone/fax number.
15.E.2.2 Personnel
The requirements concerning «personnel» (see chapter 2 Personnel) start with organisation charts which should illustrate the areas of production, quality control and quality assurance.
An overview of quantitative data regarding the staff employed in the areas of purchasing, production, engineering, quality control/assurance and storage/distribution must be provided. Both full-time and part-time staff must be included in this overview.
Key personnel must be mentioned in a further list together with their role, their professional experience and their training. This category covers the relevant heads of department and other persons charged with an activity/responsibility listed in Article 22 of Directive 75/319/EEC (e.g. «qualified person»).
A brief description of the quality management system (see chapter 1 Quality Management) is required in this chapter as much as the description of the annual training program (seechapter 2.C Training).
The following information is required for the latter.
15.E.2.3 Premises and equipment
Layout plans are a major part of this chapter in the site master file. The layout plans should be in the DIN A 4 format and be larger than this in exceptional cases only.If necessary, the plans can be enhanced with a description of the direct surroundings of the company (e.g. industrial estates in the direct vicinity).
The following plans are each required.
Furthermore, additional information on the manufacturing and packaging areas must also be provided. This information is segregated according to the dosage forms and shall comprise the number of rooms used for manufacture and packaging as well as their total area.
Information is also required in the following areas:
Premises
(See chapter 3 Premises.)
This overview must be produced for each building
This information must be refined for clean rooms. Information on the construction/nature of the floors, walls and ceilings must be supplemented in this section.
Air systems
(See chapter 3.H Heating Ventilation Air Conditioning (HVAC).)
A diagram showing the different premises and the air systems which supply these areas is required. The following information is required for each air system:
Additional information for clean rooms
For the handling of toxic and hazardous substances, a brief description of the special measures in place for the handling of these product groups is required.
Water systems
This information must be categorised depending on the water type (drinking water, purified water, water for injection).
Manufacturing and packaging equipment
Equipment in quality control areas
Maintenance/servicing and calibration
(See chapter 4.H Maintenance.)
This information will be separated according to buildings/premises, manufacturing/packaging equipment and quality control equipment
15.E.2.4 Documentation
(See chapter 15.C Batch documentation.)
Firstly. a brief description is required which shows how the required documentation for the areas of manufacture, packaging and quality controls including batch production formulas, instructions and records in addition to specifications must be compiled, reviewed and distributed.
Figure 15.E-2 Referential matrix for procedures or operating procedures
Referential matrix for procedures or operating procedures
Topic to be regulated
Section in the
EU GMP Guideline
Operating procedure(s)
of the company