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НОРМАТИВНІ ПОСИЛАННЯ
У цій настанові є посилання на такі нормативні документи: ДСТУ ISO 8258:2001 Статистичний контроль. Контрольні карти Шухарта (ISO 8258:1991, IDT) ДСТУ ISO 7966:2001 Статистичний контроль. Карти приймального контролю (ISO 7966:1993, IDT) ДСТУ ISO/IEC Guide 51-2002 Аспекти безпеки. Настанови щодо їх включення до стандартів (ISO/IEC Guide 51:1999, IDT) ДСТУ ГОСТ ИСО 14644-1:2004 Чисті приміщення і пов’язані з ними контрольовані середовища. Частина 1. Класифікація чистоти повітря (ГОСТ ИСО 14644-1-2002, IDT) ДСТУ ISO 7870:2004 Статистичний контроль. Карти вибіркового контролю. Вступ та настанови для користувача (ISO 7870:1993, IDT) ДСТУ ISO/TR 7871:2004 Статистичний контроль. Контрольні карти кумулятивних сум. Настанови щодо контролю якості та аналізу даних з використанням методик CUSUM (ISO/TR 7871:1997, IDT) ДСТУ ISO 7873:2004 Статистичний контроль. Контрольні карти для арифметичного середнього з попереджувальними межами (ISO 7873:1993, IDT) Державна Фармакопея України. Перше видання. 2001 р. Державна Фармакопея України. Перше видання. Доповнення 1. 2004 р. Державна Фармакопея України. Перше видання. Доповнення 2. 2008 р. Настанова 42-3.3:2004 Настанови з якості. Лікарські засоби. Випробування стабільності. ГОСТ Р ИСО 14971-2006 Изделия медицинские. Применение менеджмента риска к медицинским изделиям (ISO 14971:2000, IDT) 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 continuet 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/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 Commission Directive 2003/94/EC of 8 October 2003 laying down the principles of good manufacturing 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/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 (СРМР/BWP/269/95 rev. 3, 3AB12a) The Rules Governing Medicinal Products in the European Union. Volume 4. EU Guidelines to Good 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 № 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 № 908). – Annex 7 Application of Hazard Analysis and Critical Control Point (HACCP) methodology to pharmaceuticals. – P. 99-112 Довідкові джерела інформації наведено в додатку «Бібліографія».
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