Руководство по надлежащей практике производства лекарственных средств для человека



страница298/298
Дата24.10.2018
Размер1.22 Mb.
ТипРуководство
1   ...   290   291   292   293   294   295   296   297   298
БИБЛИОГРАФИЯ
1. ГОСТ Р ИСО 11134-2000 Стерилизация медицинской продукции. Требования к валидации и

текущему контролю. Промышленная стерилизация влажным теплом (ISO 11134, IDT).


2. ГОСТ Р ИСО 11138-1-2000 Стерилизация медицинской продукции. Биологические

индикаторы. Часть 1. Технические требования (ISO 11138-1, IDT).


3. ГОСТ Р ИСО 11138-3-2000 Стерилизация медицинской продукции. Биологические

индикаторы. Часть 3. Биологические индикаторы для стерилизации влажным теплом (ISO 11138-3,

IDT).
4. ГОСТ Р ИСО 13408-1-2000 Асептическое производство медицинской продукции. Часть 1.

Общие требования (ISO 13408-1, IDT).


5. ГОСТ Р ИСО 14644-4-2002 Чистые помещения и связанные с ними контролируемые среды.

Часть 4. Проектирование, строительство и ввод в эксплуатацию (ISO 14644-4, IDT).


6. ГОСТ Р 51897-2002 Менеджмент риска. Термины и определения.
7. ГОСТ Р 51901.11-2005. Менеджмент риска. Исследование опасности и работоспособности.

Прикладное руководство (МЭК 61882:2001).


8. ГОСТ Р ИСО 8573-1-2005 Сжатый воздух. Часть 1. Загрязнения и классы чистоты (ISO 8573-

1, IDT).
9. ГОСТ Р ИСО 8573-2-2005 Сжатый воздух. Часть 2. Методы контроля содержания масел в


Не является официальной версией, бесплатно предоставляется членам Ассоциации лесопользователей Приладожья, Поморья и Прионежья – www.alppp.ru. Постоянно действующий третейский суд.
виде аэрозолей (ISO 8573-2, IDT).
10. ГОСТ Р ИСО 8573-4-2005 Сжатый воздух. Часть 4. Методы контроля содержания твердых

частиц (ISO 8573-4, IDT).


11. ГОСТ Р ИСО 8573-6-2005 Сжатый воздух. Часть 6. Методы контроля загрязнения газами

(ISO 8573-6, IDT).


12. ГОСТ Р ИСО 8573-7-2005 Сжатый воздух. Часть 7. Метод контроля загрязнения

жизнеспособными микроорганизмами (ISO 8573-7, IDT).


13. ISO 11140-1:1995/Amd 1:1998 Sterilization of health care products - Chemical indicators - Part 1:

General requirements.


14. ISO 11140-2:1998 Sterilization of health care products - Chemical indicators - Part 2: Test equipment

and methods.


15. ISO 11140-3:2000 Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicators

for steam penetration test sheets.


20. ISO 11737-1:1995 Sterilization of medical devices - Microbiological methods - Part 1: Estimation of

population of microorganisms on products.


21. ISO 11737-2:1998 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility

performed in the validation of a sterilization process.


22. ISO 11607:1997 Packaging for terminally sterilized medical devices.
23. ISO 13408-1:1998 Aseptic processing of health care products - Part 1: General requirements.
24. ISO/TR 13409:1996 Sterilization of health care products - Radiation sterilization - Substantiation of 25

kGy as a sterilization dose for small or infrequent production batches.


25. ISO 14160:1998 Sterilization of single-use medical devices incorporating materials of animal origin -

Validation and routine control of sterilization by liquid chemical sterilants.


26. ISO/TR 15844:1998 Sterilization of health care products - Radiation sterilization - Selection of

sterilization dose for a single production batch.


27. ISO/DIS 14698-1:1999 Cleanrooms and associated controlled environments - Biocontamination control

- Part 1: Basic principles and determination of critical points in zones at risk.


28. ISO/DIS 14698-2:1999 Cleanrooms and associated controlled environments - Biocontamination control

- Part 2: Methods of analysing and measuring biocontamination of textiles in zones at risk.


29. ISO/DIS 14698-3:1999 Cleanrooms and associated controlled environments - Biocontamination control

- Part 3: Methods of analysing and measuring biocontamination of surfaces in zones at risk.


30. Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good

manufacturing practice for veterinary medicinal products.


31. Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the

Community code relating to veterinary medicinal products.


32. Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending

2001/82/EC on the Community code relating to veterinary medicinal products.


Не является официальной версией, бесплатно предоставляется членам Ассоциации лесопользователей Приладожья, Поморья и Прионежья – www.alppp.ru. Постоянно действующий третейский суд.
33. The Rules Governing Medicinal Products in the European Union. - Volume 4. - EU Guidelines to Good

Manufacturing Practice Medicinal Products for Human and Veterinary Use.


34. Document PI 007-1 Recommendation on the validation of aseptic processes. - PIC/S, 31 July 2001.
35. Biological products - standards. 1 Series. In: WHO Expert Committee on Biological Standardization.

Thirty-ninth report. Switzerland, World Health Organization, 1989: 9-179 (WHO Technical Report Series, N 786).


36. Good manufacturing practices: supplementary guidelines for the manufacture of herbal medicinal products.

In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-fourth report. Geneva,

World Health Organization, 1996: 109-113 (WHO Technical Report Series, N 863).
37. A WHO Guide to Good Manufacturing Practice (GMP) Requirements. Part 1: Standard Operating

Procedures and Master Formulae. - Geneva: WHO, 1997.


38. EMEA/CHMP/167068/2004 (ICH Topic Q8) Note for Guidance on Pharmaceutical Development.
39. EMEA/CHMP/QWP/49313/2005 Corr Guideline on the Pharmaceutical Quality of Inhalation and Nasal

Products.


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

Starting Materials of Herbal Origin.


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

Products/Traditional Herbal Medicinal Products.


42. 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.
43. CPMP/QWP/158/01 Rev. 1 Note for Guidance on Quality of Water for Pharmaceutical Use.
44. CPMP/QWP/122/02 Rev. 1 Guideline on stability testing: stability testing of existing active substances and

related finished products.


45. 3AQ11A Specifications and Control Tests on the Finished Product.
46. 3AQ5a Chemistry of Active Substances.
47. 3CC29A Investigation of Chiral Active Substances.
48. CPMP/QWP/130/96 Rev. 1 Guideline on the Chemistry of New Active Substances.
49. CPMP/IСН/2737/99-ICH Q3A (R2) Note for Guidance on Impurities Testing: Impurities In New Drug

Substances.


50. CPMP/ICH/2738/99-ICH Q3B (R2) Note for Guidance on Impurities in New Medicinal Products.
51. CPMP/ICH/283/95-ICH Q3C (R3) Note for Guidance on Impurities: Residual Solvents.
52. CPMP/ICH/367/96-ICH Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug

Substances and New Drug Products: Chemical Substances.


53. CPMP/BWP/3354/99 Production and Quality Control of Animal Immunoglobulins and Immunosera for

Human Use.


54. CPMP/BWP/41450/98 Points to consider on the Manufacture and Quality Control of Human Somatic
Не является официальной версией, бесплатно предоставляется членам Ассоциации лесопользователей Приладожья, Поморья и Прионежья – www.alppp.ru. Постоянно действующий третейский суд.
Cell Therapy Medicinal Products.
55. CPMP/BWP/3088/99 Quality, Preclinical and Clinical Aspects of Gene Transfer Medicinal Products.
56. CPMP/BWP/382/97 Position Statement on DNA and Host Cell Proteins (HCP) Impurities, Routine

Testing Versus Validation Studies.


57. 3AB2A CPMP/ICH/139/95 ICH Topic Q5B Quality of Biotechnological Products: Analysis of the

Expression Construct in Cell Lines used for Production of r-DNA derived Protein Products.


58. 3AB3A Production and Quality Control of Cytokine Products Derived by Biotechnological Process.
59. 3АВ6А Gene Therapy Product Quality Aspects in the Production of Vectors and Genetically Modified

Somatic Cells.


60. 3AB7A Use of Transgenic Animals in the Manufacture of Biological Medicinal Products for Human use.
61. 3AB11A Tests on Samples of Biological Origin.
62. EMEA/CHMP/49348/05 Similar Biological Medicinal Products containing Biotechnology-derived

Proteins as Active Substance: Quality Issues.


63. CHMP/437/04 Similar Biological Medicinal Product.
64. CPMP/ICH/5721/03 ICH Topic Q5E Step 4 Note for Guidance on Biotechnological/Biological Products

Subject to changes in their Manufacturing Process.


65. CPMP/BWP/3207/00 Rev. 1 Comparability of Medicinal Products containing Biotechnology-derived

Proteins as Active Substance - Quality Issues.


66. CHMP/BWP/3794/03 Rev. 1 Scientific Data Requirements for Plasma Master File (PMF).
67. CHMP/BWP/3794/03 Rev. 1 Annexes to Guideline on the Scientific Data Requirements for Plasma

Master File (PMF).


68. EMEA/CHMP/BWP/298388/05 Validation of Immunoassay for the Detection of Antibody to Human

Immunodeficiency Virus (anti-HIV) in Plasma Pools.


69. EMEA/CPMP/BWP/476/01 Public Statement on the Evaluation of Bovine Spongiform Encephalopathies

(BSE) - Risk via the Use of Materials of Bovine Origin in or during the Manufacture of Vaccines.


70. CPMP/BWP/5136/03 Investigation of Manufacturing Processes for Plasma-Derived Medicinal Products

with Regard to VCJD Risk 48. EMEA/CHMP/BWP/298390/05 Validation of Immunoassay for the Detection of

Hepatitis B Virus Surface Antigen (Hbsag) in Plasma Pools.
71. CPMP/BWP/125/04 Epidemiological Data on Blood Transmissible Infections.
72. CPMP/BWP/819/01 Questions and Answers on Bovine Spongiform Encephalopathies (BSE) and

Vaccines.


73. CPMP/BWP/4663/03 Requirements for Plasma Master File (PMF) Certification.
74. CPMP/BWP/5180/03 Assessing the Risk for Virus Transmission - New Chapter 6 of the Note for

Guidance on Plasma-Derived Medicinal Products.


75. CPMP/BWP/5136/03 Investigation of Manufacturing Processes for Plasma-Derived Medicinal Products

with Regard to VCJD risk.


Не является официальной версией, бесплатно предоставляется членам Ассоциации лесопользователей Приладожья, Поморья и Прионежья – www.alppp.ru. Постоянно действующий третейский суд.
76. CPMP/BWP/2879/02 Rev. 1 CHMP Position Statement on Creutzfeldt-Jacob Disease and Plasma-

Derived and Urine-Derived Medicinal Products.


77. CPMP/BWP/3752/03 CPMP Position Statement on West-Nile Virus and Plasma-Derived Medicinal

Products.


78. EMEA/CPMP/BWP/1818/02 CPMP Position Statement on Non-Remunerated and Remunerated

Donors: Safety and Supply of Plasma-Derived Medicinal Products.


79. CPMP/BWP/385/99 Position Paper on Plasma-Derived Medicinal Products: Alt Testing (Corrigendum,

Sept. 1999).


80. CHMP/VEG/134716/04 Adjuvants in Vaccines for Human Use.
81. CHMP/VWP/244894/2006 Explanatory Note on Immunomodulators for the Guideline on Adjuvants in

Vaccines for Human Use.


82. CPMP/4717/03 Dossier Structure and Content for Pandemic Influenza Vaccine Marketing Authorisation

Application.


83. EMEA/CPMP/4986/03 Submission of Marketing Authorisation Applications for Pandemic Influenza

Vaccines through the Centralised Procedure.


84. CPMP/4548/03/Final Rev. 1 Requirements for Vaccine Antigen Master File (VAMF) certification.
85. CPMP/BWP/1571/02 Rev. 1 CPMP Position Statement on the Quality of Water used in the production

of Vaccines for parenteral use.


86. CPMP/BWP/3734/03 Scientific Data Requirements for a Vaccine Antigen Master File (VAMF).
87. CPMP/BWP/2490/00 Cell Culture Inactivated Influenza Vaccines (Annex to Note for Guidance on

Harmonisation of requirements for Influenza Vaccines CPMP/BWP/214/96).


88. CPMP/BWP/2289/01 Points to Consider on the Development of Live Attenuated Influenza Vaccines.
89. CPMP/1100/02 Development of Vaccinia Virus Based Vaccines Against Smallpox.
90. CPMP/BWP/2517/00 Points to Consider on the Reduction, Elimination or Substitution of Thiomersal in

Vaccines.


91. EMEA/CPMP/BWP/476/01 Public Statement on the Evaluation of Bovine Spongiform Encephalopathies

(BSE) - risk via the Use of Materials of Bovine Origin in or during the Manufacture of Vaccines.


92. CPMP/BWP/477/97 Pharmaceutical and Biological Aspects of Combined Vaccines.
93. CPMP/BWP/214/96 Harmonisation of Requirements for Influenza Vaccines.
94. CPMP/BWP/328/99 Development Pharmaceutics for Biotechnological and Biological Products - Annex

to Note for Guidance on Development Pharmaceutics.


95. EMEA/CHMP/BWP/124446/05 Potency Labelling for Insulin Analogue Containing Products with

Particular Reference to the Use of "International Units" or "Units".


96. EMEA/CHMP/VEG/193031/04 Core SPC for Pandemic Influenza Vaccines.
97. CPMP/BWP/2758/02 Pharmaceutical Aspects of the Product Information for Human Vaccines.
Не является официальной версией, бесплатно предоставляется членам Ассоциации лесопользователей Приладожья, Поморья и Прионежья – www.alppp.ru. Постоянно действующий третейский суд.
98. CPMP/BWP/2879/02 Rev. 1 CHMP Position Statement on Creutzfeldt-Jacob Disease and Plasma-

Derived and Urine-Derived Medicinal Products.


99. EMEA/CHMP/473191/06 Corr. Environmental Risk Assessments for Medicinal Products containing, or

consisting of, Genetically Modified Organisms (GMOs).


100. CPMP/BWP/1793/02 Guidance on the Use of Bovine Serum in the Manufacture of Human Biological

Medicinal Products.


101. CPMP/BWP/972/98 Position Paper on Viral Safety of Oral Poliovirus Vaccine (OPV).
102. EMEA/CHMP/BWP/27/04 First Cases of BSE in USA and Canada: Risk Assessment of Ruminant

Materials Originating from USA and Canada.


103. EMEA/410/01 Rev. 2 Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents

via Human and Veterinary Medicinal Products.


104. EMEA/22314/02 Position Paper on Re-establishment of Working Seeds and Working Cell Banks using

TSE compliant materials.


105. EMEA/CPMP/BWP/337/02 Final. Public Report on Risk and Regulatory Assessment of Lactose and

other Products Prepared Using Calf Rennet.


106. EMEA/CPMP/BWP/498/01 Joint CPMP/CVMP Note for Guidance on Minimising the Risk of

Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products.


107. Process Mapping by the American Productivity & Quality Center 2002, ISBN 1928593739.
108. What is Total Quality Control; The Japanese Way, Kaoru Ishikawa (Translated by David J. Liu, 1985,

ISBN 0139524339.


109. Failure Mode and Effects Analysis, FMEA from Theory to Execution, 2nd Edition 2003, D.H.Stamatis,

ISBN 0873895983.


110. The Basics of FMEA, Robin McDermott, Raymond J. Mikulak, Michael R. Beauregard 1996 ISBN

0527763209.


111. Guidelines for Failure Modes and Effects Analysis (FMEA) for Medical Devices, 2003 Dyadem Press

ISBN 0849319102.


Не является официальной версией, бесплатно предоставляется членам Ассоциации лесопользователей Приладожья, Поморья и Прионежья – www.alppp.ru. Постоянно действующий третейский суд.
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


Поделитесь с Вашими друзьями:
1   ...   290   291   292   293   294   295   296   297   298


База данных защищена авторским правом ©zodorov.ru 2017
обратиться к администрации

    Главная страница