3 курс / Фармакология / Руководство_по_надлежащей_производственной_практике_лекарственных (1)

281

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 Vac-

cines

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 Vac-

cines

97.CPMP/BWP/2758/02 Pharmaceutical Aspects of the Product Information for Human Vaccines

98.CPMP/BWP/2879/02 Rev. 1 CHMP Position Statement on CreutzfeldtJacob Disease and Plasma-Derived and Urine-Derived Medicinal Products

282

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

283

УДК 661.12:615.012

Ключевые слова: активный фармацевтический ингредиент (действующее вещество), валидация, производство, документация, обеспечение качества, контроль качества, лекарственное средство, надлежащая производственная практика, технологический процесс, самоинспекция.