gmp (Руководство по производству лекарственных средств (GMP)), страница 66
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CPMP/BWP/382/97 Position Statement on DNA and Host Cell Proteins(HCP) Impurities, Routine Testing Versus Validation Studies57. 3AB2A CPMP/ICH/139/95 ICH Topic Q5B Quality of BiotechnologicalProducts: Analysis of the Expression Construct in Cell Lines used for Production of rDNA derived Protein Products58.
3AB3A Production and Quality Control of Cytokine Products Derived byBiotechnological Process28059. 3AB6A Gene Therapy Product Quality Aspects in the Production of Vectors and Genetically Modified Somatic Cells60. 3AB7A Use of Transgenic Animals in the Manufacture of Biological Medicinal Products for Human use61. 3AB11A Tests on Samples of Biological Origin62. EMEA/CHMP/49348/05 Similar Biological Medicinal Products containingBiotechnology-derived Proteins as Active Substance: Quality Issues63. CHMP/437/04 Similar Biological Medicinal Product64.
CPMP/ICH/5721/03 ICH Topic Q5E Step 4 Note for Guidance on Biotechnological/Biological Products Subject to changes in their Manufacturing Process65. CPMP/BWP/3207/00 Rev. 1 Comparability of Medicinal Products containing Biotechnology-derived Proteins as Active Substance – Quality Issues66.
CHMP/BWP/3794/03 Rev. 1 Scientific Data Requirements for PlasmaMaster File (PMF)67. CHMP/BWP/3794/03 Rev. 1 Annexes to Guideline on the Scientific DataRequirements 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 Pools69.
EMEA/CPMP/BWP/476/01 Public Statement on the Evaluation of BovineSpongiform Encephalopathies (BSE) – Risk via the Use of Materials of Bovine Origin in or during the Manufacture of Vaccines70. CPMP/BWP/5136/03 Investigation of Manufacturing Processes for PlasmaDerivedMedicinalProductswithRegardtoVCJDRisk48.EMEA/CHMP/BWP/298390/05 Validation of Immunoassay for the Detection of Hepatitis B Virus Surface Antigen (Hbsag) in Plasma Pools71. CPMP/BWP/125/04 Epidemiological Data on Blood Transmissible Infections72. CPMP/BWP/819/01 Questions and Answers on Bovine Spongiform Encephalopathies (BSE) and Vaccines73. CPMP/BWP/4663/03 Requirements for Plasma Master File (PMF) Certification74.
CPMP/BWP/5180/03 Assessing the Risk for Virus Transmission – NewChapter 6 of the Note for Guidance on Plasma-Derived Medicinal Products75. CPMP/BWP/5136/03 Investigation of Manufacturing Processes for PlasmaDerived Medicinal Products with Regard to VCJD risk76. CPMP/BWP/2879/02 Rev. 1 CHMP Position Statement on CreutzfeldtJacob Disease and Plasma-Derived and Urine-Derived Medicinal Products77.
CPMP/BWP/3752/03 CPMP Position Statement on West-Nile Virus andPlasma-Derived Medicinal Products78. EMEA/CPMP/BWP/1818/02 CPMP Position Statement on NonRemunerated and Remunerated Donors: Safety and Supply of Plasma-Derived Medicinal Products28179. 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 Use81. CHMP/VWP/244894/2006 Explanatory Note on Immunomodulators for theGuideline on Adjuvants in Vaccines for Human Use82.
CPMP/4717/03 Dossier Structure and Content for Pandemic Influenza Vaccine Marketing Authorisation Application83. EMEA/CPMP/4986/03 Submission of Marketing Authorisation Applications for Pandemic Influenza Vaccines through the Centralised Procedure84. CPMP/4548/03/Final Rev 1 Requirements for Vaccine Antigen Master File(VAMF) certification85. CPMP/BWP/1571/02 Rev 1 CPMP Position Statement on the Quality ofWater used in the production of Vaccines for parenteral use86.
CPMP/BWP/3734/03 Scientific Data Requirements for a Vaccine AntigenMaster File (VAMF)87. CPMP/BWP/2490/00 Cell Culture Inactivated Influenza Vaccines (Annexto Note for Guidance on Harmonisation of requirements for Influenza VaccinesCPMP/BWP/214/96)88. CPMP/BWP/2289/01 Points to Consider on the Development of Live Attenuated Influenza Vaccines89. CPMP/1100/02 Development of Vaccinia Virus Based Vaccines AgainstSmallpox90. CPMP/BWP/2517/00 Points to Consider on the Reduction, Elimination orSubstitution of Thiomersal in Vaccines91. EMEA/CPMP/BWP/476/01 Public Statement on the Evaluation of BovineSpongiform Encephalopathies (BSE) – risk via the Use of Materials of Bovine Originin or during the Manufacture of Vaccines92.
CPMP/BWP/477/97 Pharmaceutical and Biological Aspects of CombinedVaccines93. CPMP/BWP/214/96 Harmonisation of Requirements for Influenza Vaccines94. CPMP/BWP/328/99 Development Pharmaceutics for Biotechnological andBiological Products – Annex to Note for Guidance on Development Pharmaceutics95. EMEA/CHMP/BWP/124446/05 Potency Labelling for Insulin AnalogueContaining Products with Particular Reference to the Use of «International Units» or«Units»96. EMEA/CHMP/VEG/193031/04 Core SPC for Pandemic Influenza Vaccines97. CPMP/BWP/2758/02 Pharmaceutical Aspects of the Product Informationfor Human Vaccines98.
CPMP/BWP/2879/02 Rev. 1 CHMP Position Statement on CreutzfeldtJacob Disease and Plasma-Derived and Urine-Derived Medicinal Products28299. 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 Products101.
CPMP/BWP/972/98 Position Paper on Viral Safety of Oral PoliovirusVaccine (OPV)102. EMEA/CHMP/BWP/27/04 First Cases of BSE in USA and Canada: RiskAssessment of Ruminant Materials Originating from USA and Canada103. EMEA/410/01 Rev. 2 Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products104. EMEA/22314/02 Position Paper on Re-establishment of Working Seedsand Working Cell Banks using TSE compliant materials105. EMEA/CPMP/BWP/337/02 Final. Public Report on Risk and RegulatoryAssessment of Lactose and other Products Prepared Using Calf Rennet106.
EMEA/CPMP/BWP/498/01 Joint CPMP/CVMP Note for Guidance onMinimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents viaHuman and Veterinary Medicinal Products107. Process Mapping by the American Productivity & Quality Center 2002,ISBN 1928593739108. What is Total Quality Control; The Japanese Way, Kaoru Ishikawa(Translated by David J. Liu, 1985, ISBN 0139524339109.
Failure Mode and Effects Analysis, FMEA from Theory to Execution, 2ndEdition 2003, D.H. Stamatis, ISBN 0873895983110. The Basics of FMEA, Robin McDermott, Raymond J. Mikulak, MichaelR. Beauregard 1996 ISBN 0527763209111. Guidelines for Failure Modes and Effects Analysis (FMEA) for MedicalDevices, 2003 Dyadem Press ISBN 0849319102283УДК 661.12:615.012Ключевые слова: активный фармацевтический ингредиент (действующее вещество), валидация, производство, документация, обеспечение качества,контроль качества, лекарственное средство, надлежащая производственнаяпрактика, технологический процесс, самоинспекция..
