Національний додаток (довідковий) бібліографія
1. ДСТУ ISO 13683:2003 Стерилізація виробів медичної призначеності. Вимоги до валідації і поточного контролювання. Стерилізація вологим теплом у медичних установах (ISO 13683:1997, IDT)
2. ДСТУ ISO/TR 13409:2003 Стерилізація виробів медичної призначеності. Радіаційна стерилізація. Обґрунтування дози стерилізації 25 кГр, як дози для малих або разових партій виробництва (ISO/TR 13409:1996, IDT)
3. ДСТУ ISO 11134:2003 Стерилізація виробів медичної призначеності. Вимоги до оцінювання відповідності та поточного контролювання. Промислова стерилізація вологим теплом (ISO 11134:1994, IDT)
4. ДСТУ ISO 11135:2003 Стерилізація виробів медичного призначення. Валідація та поточний контроль стерилізації оксидом етилену (ISO 11135:1994, IDT)
5. ДСТУ ISO 11137:2003 Стерилізація виробів медичного призначення. Вимоги до валідації та поточного контролю. Радіаційна стерилізація (ISO 11137:1995, IDT)
6. ДСТУ ISO 11138-1:2003 Стерилізація виробів медичної призначеності. Біологічні індикатори. Частина 1. Загальні вимоги (ISO 11138-1:1994, IDT)
7. ДСТУ ISO 11138-2:2003 Стерилізація виробів медичної призначеності. Біологічні індикатори. Частина 2. Біологічні індикатори для стерилізації оксидом етилену (ISO 11138-2:1994, IDT)
8. ДСТУ ISO 11138-3:2003 Стерилізація виробів медичної призначеності. Біологічні індикатори. Частина 3. Біологічні індикатори для стерилізації вологим теплом (ISO 11138-3:1995, IDT)
9. ДСТУ ISO 11140-1:2003 Стерилізація виробів медичної призначеності. Хімічні індикатори. Частина 1. Загальні вимоги (ISO 11140-1:1995, IDT)
10. ДСТУ ISO 10993-7:2004 Біологічне оцінювання медичних виробів. Частина 7. Залишки після стерилізації етиленоксидом (ISO 10993-7:1995, IDT)
11. ISO 11140-1:1995/Amd 1:1998 Sterilization of health care products – Chemical indicators – Part 1: General requirements
12. ISO 11140-2:1998 Sterilization of health care products – Chemical indicators – Part 2: Test equipment and methods
13. ISO 11140-3:2000 Sterilization of health care products – Chemical indicators – Part 3: Class 2 indicators for steam penetration test sheets
14. ISO 11607:1997 Packaging for terminally sterilized medical devices
15. ISO 11737-1:1995 Sterilization of medical devices – Microbiological methods – Part 1: Estimation of population of microorganisms on products
16. ISO 11737-2:1998 Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility performed in the validation of a sterilization process
17. ISO 13408-1:1998 Aseptic processing of health care products – Part 1: General requirements
18. 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
19. ISO 14160:1998 Sterilization of single-use medical devices incorporating materials of animal origin – Validation and routine control of sterilization by liquid chemical sterilants
20. ISO/TR 15844:1998 Sterilization of health care products – Radiation sterilization – Selection of sterilization dose for a single production batch
21. 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
22. 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
23. 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
24. Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products
25. 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
26. 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
27. EudraLex. – The Rules Governing Medicinal Products in the European Union. – Volume 4. EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use
http://ec.europa.eu/health/documents/eudralex/vol-4/index en.htm
28. Document PI 007-1 Recommendation on the validation of aseptic processes. – PIC/S, 31 July 2001.
29. РЕ 008-4 (1 Annex) Explanatory Notes for Pharmaceutical Manufacturers on the Preparation of a Site Master File, 1 January 2011
30. 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, № 863)
31. A WHO Guide to Good Manufacturing Practice (GMP) Requirements. Part 1: Standard Operating Procedures and Master Formulae. – Geneva: WHO, 1997
32. EMEA/CHMP/167068/2004 (ICH Topic Q8) Note for Guidance on Pharmaceutical Development
33. EMEA/CHMP/QWP/49313/2005 Corr Guideline on the Pharmaceutical Quality of Inhalation and Nasal Products
34. EMEA/HMPC/246816/2005 Guideline on Good Agricultural and Collection Practice (GACP) for Starting Materials of Herbal Origin
35. CPMP/QWP/2819/00 (EMEA/CVMP/814/00) Guideline on Quality of Herbal Medicinal Products / Traditional Herbal Medicinal Products
36. 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
37. CPMP/QWP/158/01 Rev. 1 Note for Guidance on Quality of Water for Pharmaceutical Use
38. CPMP/QWP/122/02 Rev 1 Guideline on stability testing: stability testing of existing active substances and related finished products
39. 3AQ11A Specifications and Control Tests on the Finished Product
40. 3AQ5a Chemistry of Active Substances
41. 3CC29A Investigation of Chiral Active Substances
42. CPMP/QWP/130/96 Rev. 1 Guideline on the Chemistry of New Active Substances
43. CPMP/ICH/2737/99-ICH Q3A (R2) Note for Guidance on Impurities Testing: Impurities In New Drug Substances
44. CPMP/ICH/2738/99-ICH Q3B (R2) Note for Guidance on Impurities in New Medicinal Products
45. CPMP/ICH/283/95-ICH Q3C (R3) Note for Guidance on Impurities: Residual Solvents
46. CPMP/ICH/367/96-ICH Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
47. CPMP/BWP/3354/99 Production and Quality Control of Animal Immunoglobulins and Immunosera for Human Use
48. CPMP/BWP/41450/98 Points to consider on the Manufacture and Quality Control of Human Somatic Cell Therapy Medicinal Products
49. CPMP/BWP/3088/99 Quality, Preclinical and Clinical Aspects of Gene Transfer Medicinal Products
50. CPMP/BWP/382/97 Position Statement on DNA and Host Cell Proteins (HCP) Impurities, Routine Testing Versus Validation Studies
51. 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
52. 3AB3A Production and Quality Control of Cytokine Products Derived by Biotechnological Process
53. 3AB6A Gene Therapy Product Quality Aspects in the Production of Vectors and Genetically Modified Somatic Cells
54. 3AB7A Use of Transgenic Animals in the Manufacture of Biological Medicinal Products for Human use
55. 3AB11A Tests on Samples of Biological Origin
56. EMEA/CHMP/49348/05 Similar Biological Medicinal Products containing Biotechnology-derived Proteins as Active Substance: Quality Issues
57. CHMP/437/04 Similar Biological Medicinal Product
58. CPMP/ICH/5721/03 ICH Topic Q5E Step 4 Note for Guidance on Biotechnological/Biological Products Subject to changes in their Manufacturing Process
59. CPMP/BWP/3207/00 Rev. 1 Comparability of Medicinal Products containing Biotechnology-derived Proteins as Active Substance – Quality Issues
60. CHMP/BWP/3794/03 Rev. 1 Scientific Data Requirements for Plasma Master File (PMF)
61. CHMP/BWP/3794/03 Rev. 1 Annexes to Guideline on the Scientific Data Requirements for Plasma Master File (PMF)
62. EMEA/CHMP/BWP/298388/05 Validation of Immunoassay for the Detection of Antibody to Human Immunodeficiency Virus (anti-HIV) in Plasma Pools
63. 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
64. 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
65. CPMP/BWP/125/04 Guideline on Epidemiological Data on Blood Transmissible Infections
66. CPMP/BWP/819/01 Questions and Answers on Bovine Spongiform Encephalopathies (BSE) and Vaccines
67. CPMP/BWP/4663/03 Requirements for Plasma Master File (PMF) Certification
68. CPMP/BWP/5180/03 Assessing the Risk for Virus Transmission – New Chapter 6 of the Note for Guidance on Plasma-Derived Medicinal Products
69. CPMP/BWP/5136/03 Investigation of Manufacturing Processes for Plasma-Derived Medicinal Products with Regard to VCJD risk
70. CPMP/BWP/2879/02 Rev. 1 CHMP Position Statement on Creutzfeldt-Jacob Disease and Plasma-Derived and Urine-Derived Medicinal Products
71. CPMP/BWP/3752/03 CPMP Position Statement on West-Nile Virus and Plasma-Derived Medicinal Products
72. EMEA/CPMP/BWP/1818/02 CPMP Position Statement on Non-Remunerated and Remunerated Donors: Safety And Supply of Plasma-Derived Medicinal Products
73. CPMP/BWP/385/99 Position Paper on Plasma-Derived Medicinal Products: Alt Testing (Corrigendum, Sept. 1999)
74. CHMP/VEG/134716/04 Adjuvants in Vaccines for Human Use
75. CHMP/VWP/244894/2006 Explanatory Note on Immunomodulators for the Guideline on Adjuvants in Vaccines for Human Use
76. CPMP/4717/03 Dossier Structure and Content for Pandemic Influenza Vaccine Marketing Authorisation Application
77. EMEA/CPMP/4986/03 Submission of Marketing Authorisation Applications for Pandemic Influenza Vaccines through the Centralised Procedure
78. CPMP/4548/03/Final Rev 1 Requirements for Vaccine Antigen Master File (VAMF) certification
79. CPMP/BWP/1571/02 Rev 1 CPMP Position Statement on the Quality of Water used in the production of Vaccines for parenteral use
80. CPMP/BWP/3734/03 Scientific Data Requirements for a Vaccine Antigen Master File (VAMF)
81. 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)
82. CPMP/BWP/2289/01 Points to Consider on the Development of Live Attenuated Influenza Vaccines
83. CPMP/1100/02 Development of Vaccinia Virus Based Vaccines Against Smallpox
84. CPMP/BWP/2517/00 Points to Consider on the Reduction, Elimination or Substitution of Thiomersal in Vaccines
85. 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
86. CPMP/BWP/477/97 Pharmaceutical and Biological Aspects of Combined Vaccines
87. CPMP/BWP/214/96 Harmonisation of Requirements for Influenza Vaccines
88. CPMP/BWP/328/99 Development Pharmaceutics for Biotechnological and Biological Products – Annex to Note for Guidance on Development Pharmaceutics
89. EMEA/CHMP/BWP/124446/05 Potency Labelling for Insulin Analogue Containing Products with Particular Reference to the Use of «International Units» or «Units»
90. EMEA/CHMP/VEG/193031/04 Core SPC for Pandemic Influenza Vaccines
91. CPMP/BWP/2758/02 Pharmaceutical Aspects of the Product Information for Human Vaccines
92. CPMP/BWP/2879/02 Rev. 1 CHMP Position Statement on Creutzfeldt-Jacob Disease and Plasma-Derived and Urine-Derived Medicinal Products
93. EMEA/CHMP/473191/06 Corr. Environmental Risk Assessments for Medicinal Products containing, or consisting of, Genetically Modified Organisms (GMOs)
94. CPMP/BWP/1793/02 Guidance on the Use of Bovine Serum in the Manufacture of Human Biological Medicinal Products
95. CPMP/BWP/972/98 Position Paper on Viral Safety of Oral Poliovirus Vaccine (OPV)
96. EMEA/CHMP/BWP/27/04 First Cases of BSE in USA and Canada: Risk Assessment of Ruminant Materials Originating from USA and Canada
97. EMEA/410/01 Rev. 2 Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products
98. EMEA/22314/02 Position Paper on Re-establishment of Working Seeds and Working Cell Banks using TSE compliant materials
99. EMEA/CPMP/BWP/337/02 Final. Public Report on Risk and Regulatory Assessment of Lactose and other Products Prepared Using Calf Rennet
100. 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
101. Process Mapping by the American Productivity & Quality Center 2002, ISBN 1928593739
102. What is Total Quality Control; The Japanese Way, Kaoru Ishikawa (Translated by David J. Liu, 1985, ISBN 0139524339
103. Failure Mode and Effects Analysis, FMEA from Theory to Execution, 2nd Edition 2003, D.H. Stamatis, ISBN 0873895983
104. The Basics of FMEA, Robin McDermott, Raymond J. Mikulak, Michael R. Beauregard 1996 ISBN 0527763209
105. Guidelines for Failure Modes and Effects Analysis (FMEA) for Medical Devices, 2003 Dyadem Press ISBN 0849319102
106. 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, № 786)
107. CHMP/QWP/306970/2007 Rev. 1 Radiopharmaceuticals
108. CPMP/QWP/1719/00 Guideline on Medicinal Gases: Pharmaceutical Documentation
109. CHMP/QWP/569959/2008 Parametric Release
110. CPMP/QWP/159/01 Limitation to the Use of Ethylene Oxide in the Manufacture of Medicinal Products
111. EMEA/CHMP/CVMP/QWP/17760/2009 Use of Near Infrared Spectroscopy (NIRS) by the Pharmaceutical Industry and the Data Requirements for new Submissions and Variations
112. CPMP/BWP/328/97. – Development Pharmaceutics for Biotechnological and Biological Products – Annex to Note for Guidance on Development Pharmaceutics (CPMP/QWP/155/96)
113. EudraLex. – The Rules Governing Medicinal Products in the European Union. – Volume 4. Good Manufacturing Practice Medicinal Products for Human and Veterinary Use. – Explanatory Notes on the preparation of a Site Master File. – European Comission, Brüssels, SANCO/C8/AM/sl/ares (2010) 1064603. – 8 p.
http://ec.europa.eu/health/documents/eudralex/vol-4/index en.htm
114. 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
УДК 661.12:615.012
Ключові слова: активний фармацевтичний інгредієнт (діюча речовина), валідація, виробництво, документація, забезпечення якості, контроль якості, лікарський засіб, належна виробнича практика, технологічний процес, самоінспекція, управління ризиком для якості.
1 Див. також розділ «Національний вступ».