Руководство по надлежащей практике производства лекарственных средств для человека



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НОРМАТИВНЫЕ ССЫЛКИ
В настоящем руководстве приведены ссылки на следующие стандарты:
ГОСТ Р ИСО 14644-1-2000 Чистые помещения и связанные с ними контролируемые среды.

Часть 1. Классификация чистоты воздуха (ISO 14644-1:99, IDT).


ГОСТ Р ИСО 14644-2-2001 Чистые помещения и связанные с ними контролируемые среды.

Часть 2. Требования к контролю и мониторингу для подтверждения постоянного соответствия ГОСТ

Р ИСО 14644-1 (ISO 14644-2:2000, IDT).
Не является официальной версией, бесплатно предоставляется членам Ассоциации лесопользователей Приладожья, Поморья и Прионежья – www.alppp.ru. Постоянно действующий третейский суд.
ГОСТ Р ИСО 14971-2006 Изделия медицинские. Применение менеджмента риска к

медицинским изделиям (ISO 14971:2000, IDT).


Руководство по валидации методик анализа лекарственных средств/Под ред. Н.В.Юргеля,

А.Л.Младенцева, А.В.Бурдейна и др. Разработчики: В.Л.Багирова, А.И.Гризодуб, Т.Х.Чибиляев и др. -

М., 2007. - 48 с.
ISO 7870:1993 Control Charts.
ISO 7966:1993 Acceptance Control Charts.
ISO 8258:1993 Shewhart Control Charts.
ISO 7871:1997 Cumulative Sum Charts.
ISO/IEC Guide 51:1999 Safety Aspects - Guideline for their inclusion in standards.
ISO 14644-1:1999 Cleanrooms and associated controlled environments - Part 1: Classification of air

cleanliness.


ISO 14644-2:2000 Cleanrooms and associated controlled environments - Part 2: Specifications for testing

and monitoring to prove continue compliance with ISO 14644-1.


ISO 14971:2000 Application of Risk Management to Medical Devises.
ISO/IEC Guide 73:2002 Risk Management - Vocabulary - Guidelines for use in Standards.
ISO 10286:2007 Gas Cylinder - Terminology.
IEC 61025 Fault Tree Analysis (FTA).
IEC 60812 Analysis Techniques for system reliability - Procedures for failure mode and effects analysis

(FMEA).
IEC 61882 Hazard Operability Analysis (HAZOP).


Council Directive 86/609/EЕC of 24 November 1986 on the approximation of laws, regulations and

administrative provisions of the Member States regarding the protection of animals used for experimental and other

scientific purposes.
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of

the laws, regulations and administrative provisions of the Member States relating to the implementation of good

clinical practice in the conduct of clinical trials on medicinal products for human use.
Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of

quality and safety for the collection, testing, processing, storage and distribution of human blood and blood

components and amending Directive 2001/83/EC.
Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European

Parliament and of the Council on the Community code relating to medicinal products for human use.


Directive 2003/65/EC of the European Parliament and of the Council of 22 July 2003 amending Council

Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative

provisions of the Member States regarding the protection of animals used for experimental and other scientific

purposes.


Commission Directive 2003/94/EC of 8 October 2003 laying down the principles of good manufacturing
Не является официальной версией, бесплатно предоставляется членам Ассоциации лесопользователей Приладожья, Поморья и Прионежья – www.alppp.ru. Постоянно действующий третейский суд.
practice in respect of medicinal products for human use and investigational medicinal products for human use.
Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards

traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products

for human use.
Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive

2001/83/EC on the Community code relating to medicinal products for human use.


III/5272/94 Contribution to part II of the structure of the dossier for applications for marketing authorisation -

control of starting materials for the production of blood derivatives.


Council of Europe Recommendation of 29 June 1998 On the suitability of blood and plasma donors and the

screening of donated blood in the European Community (98/463/EC).


Council of Europe Press. - Guide to the preparation, use and quality assurance of blood components.
European Pharmacopoeia. 6th Edition. European Directorate for the Quality of Medicines (EDQM). -

Council of Europe, 67075 Strasbourg Cedex, France 2007. - 3308 p.


Human Plasma for Fractionation. - European Pharmacopoeia 6.0. - P. 2073-2075.
CPMP/ICH/381/95 Note for Guidance on Validation of Analytical Procedures: Text and Methodology.
CPMP/ICH/2736/99 corr (Q1A R) Note for guidance on stability testing: stability testing of new drug

substances and products.


CPMP/QWP/609/96/Rev 2 Guideline on declaration of storage conditions: A: in the product information of

medicinal products; B: for active substances.


CPMP/QWP/2819/00 (EMEA/CVMP/814/00) Guideline on Quality of Herbal Medicinal

Products/Traditional Herbal Medicinal Products.


CPMP/QWP/2820/00 (EMEA/CVMP/815/00) Guideline on Specifications: Test Procedures and Criteria for

Herbal Substances, Herbal Preparations and Herbal Medicinal Products/Traditional Herbal Medicinal Products.


EMEA/HMPC/246816/2005 Guideline on Good Agricultural and Collection Practice (GACP) for Starting

Materials of Herbal Origin.


The Rules Governing Medicinal Products in the European Union. Volume 3A. Medicinal products for human

use. Quality and biotechnology. The use of ionising radiation in the manufacture of medicinal products (3AQ4a).


The Rules Governing Medicinal Products in the European Union. Volume 3A. Medicinal products for human

use. Quality and biotechnology. Production and quality control of medicinal products derived by recombinant DNA

technology (3AB1a).
The Rules Governing Medicinal Products in the European Union. Volume 3A. Medicinal products for human

use. Quality and biotechnology. Production and quality control of monoclonal antibodies (3AB4a).


The Rules Governing Medicinal Products in the European Union. Volume 3A. Medicinal products for human

use. Quality and biotechnology. Virus validation studies: the design, contribution and interpretation of studies

validating the inactivation and removal of viruses (CPMP/BWP/268/95, 3AB8a).
The Rules Governing Medicinal Products in the European Union. Volume 3A. Medicinal products for human

use. Quality and biotechnology. Plasma-derived medicinal products (CPMP/BWP/269/95 rev. 3, 3AB12a).


The Rules Governing Medicinal Products in the European Union. Volume 4. EU Guidelines to Good
Не является официальной версией, бесплатно предоставляется членам Ассоциации лесопользователей Приладожья, Поморья и Прионежья – www.alppp.ru. Постоянно действующий третейский суд.
Manufacturing Practice Medicinal Products for Human and Veterinary Use.
ICH Q2A Guideline on Validation of Analytical Procedures: Methodology.
ICH Q2B Guideline on Validation of Analytical Procedures: Definitions and Terminology.
ICH Q5A Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived

From Cell Lines of Human or Animal Origin.


ICH Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products.
ICH Q5D Quality of Biotechnological Products: Derivation and Characterisation of Cell Substrates Used for

Production of Biotechnological/Biological Products.


ICH Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug

Products: Chemical Substances.


ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products.
ICH Q7A Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.
ICH Q8 Pharmaceutical development.
ICH Q9 Quality Risk Management.
Guidelines for Drinking-water Quality. Volume 1: Recommendations. - Second edition. - WHO, 1993. - X +

188 p.
WHO Expert Committee on Specifications for Biological Standardization. Forty-third Report. Geneva, World

Health Organization, 1994 (WHO Technical Report Series N 840).
Guidelines for Drinking-water Quality. Volume 2: Health Criteria and Other Supporting Information. - Second

edition. - WHO, 1996. - XVI + 973 p.


Guidelines for Drinking-water Quality. Volume 3: Surveillance and Control of Community Water Supplies. -

Second edition. - WHO, 1997. - XII + 238 p.


Guidelines for Drinking-water Quality. Addendum to Volume 1: Recommendations. - WHO, 1998. - VIII +

36 p.
Guidelines for Drinking-water Quality. Addendum to Volume 2: Health Criteria and Other Supporting

Information. - Second edition. - WHO, 1998. - VIII + 283 p.
Guidelines for Drinking-water Quality. Addendum: Microbiological Agents in Drinking-water. - WHO, 2001.

- 141 p.
WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-seventh Report. Geneva,

World Health Organization, 2003 (WHO Technical Report Series N 908). - Annex 7 Application of Hazard

Analysis and Critical Control Point (HACCP) methodology to pharmaceuticals. - P. 99-112


Справочные источники информации приведены в приложении "Библиография".

Каталог: law -> hozjajstvennaja-dejatelnost -> promyshlennost
promyshlennost -> Бобков ю. Г., Бабаян э. А., Машковский м. Д., Обоймакова а. Н., Булаев в. М., Гуськова л. С., Лепахин в. К., Любимов б. И., Натрадзе а. Г
promyshlennost -> Производство инфузий в россии: опасная "игра" по разным
promyshlennost -> Инструкция по определению витамина a и бета-каротина в пищевых продуктах
promyshlennost -> Локализация и механизмы действия лекарственных веществ. "Мишени" для лекарственных веществ
promyshlennost -> Растительное сырье редакционная коллегия государственной фармакопеи СССР
promyshlennost -> Экспериментальное животное: основы правового регулирования


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