Eu Gmp Annex 15 Concept Paper For Dissertation

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75. Brussels: European Commission; 2010. European Commission, Enterprise and Industry Directorate-General. Eudralex-EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Manufacture of Medicinal Gases. Vol. 4, Annex 6.

76. Geneva: PIC/S Secretariat; 2013. Pharmaceutical Inspection Convention, Pharmaceutical Inspection Co-operation Scheme, International Guide to Good Manufacturing Practice for Medicinal Products, Manufacture of medicinal gases, Annex 6.

77. Brussels: European Commission; 2010. European Commission, Enterprise and Industry Directorate-General. Eudralex-EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Investigational Medicinal Products. Vol. 4, Annex 13.

78. Geneva: PIC/S Secretariat; 2013. Pharmaceutical Inspection Convention, Pharmaceutical Inspection Co-operation Scheme, International Guide to Good Manufacturing Practice for Medicinal Products, Manufacture of investigational medicinal products, Annex 13.

79. Geneva: WHO Press; 1996. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Annex 7-Good Manufacturing Practices: Supplementary Guidelines for the Manufacture of Investigational Pharmaceutical Products for Clinical Trials in Humans. WHO Technical Report Series, No 863, Thirty-fourth Report.

80. Brussels: European Commission; 2011. European Commission, Health and Consumers Directorate-General. Eudralex-EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Manufacture of Medicinal Products Derived from Human Blood or Plasma. Vol. 4, Annex 14.

81. Geneva: PIC/S Secretariat; 2013. Pharmaceutical Inspection Convention, Pharmaceutical Inspection Co-operation Scheme, International Guide to Good Manufacturing Practice for Medicinal Products, Manufacture of products derived from human blood or human plasma, Annex 14.

82. Brussels: European Commission; 2008. European Commission, Enterprise and Industry Directorate-General. Eudralex-EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Manufacture of Herbal Medicinal Products. Vol. 4, Annex 7.

83. Geneva: PIC/S Secretariat; 2013. Pharmaceutical Inspection Convention, Pharmaceutical Inspection Co-operation Scheme, International Guide to Good Manufacturing Practice for Medicinal Products, Manufacture of Herbal Medicinal Products, Annex 7.

84. Geneva: WHO Press; 2006. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Annex 3-Supplementary Guidelines on Good Manufacturing Practices for the Manufacture of Herbal Medicines. WHO Technical Report Series, No 937, Fortieth Report.

85. Brussels: European Commission; 1991. European Commission. Eudralex-EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Use of Ionizing Radiation in the Manufacture of Medicinal Products. Vol. 4, Annex 12.

86. Geneva: PIC/S Secretariat; 2013. Pharmaceutical Inspection Convention, Pharmaceutical Inspection Co-operation Scheme, International Guide to Good Manufacturing Practice for Medicinal Products, Use of Ionizing Radiation in the Manufacture of Medicinal Products, Annex 12.

87. Brussels: European Commission; 1991. European Commission. Eudralex-EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Sampling of Starting and Packaging Materials. Vol. 4, Annex 8.

88. Geneva: PIC/S Secretariat; 2013. Pharmaceutical Inspection Convention, Pharmaceutical Inspection Co-operation Scheme, International Guide to Good Manufacturing Practice for Medicinal Products, Sampling of Starting and Packaging Materials, Annex 8.

89. Geneva: WHO Press; 2005. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Annex 2-Good Manufacturing Practices: Requirement for the Sampling of Starting Materials (amendment). WHO Technical Report Series, No 929, Thirty-ninth Report.

90. Brussels: European Commission; 2011. European Commission, Health and Consumers Directorate-General. Eudralex-EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Computerised Systems. Vol. 4, Annex 11.

91. Current Good Manufacturing Practice for Finished Pharmaceutical, Electronic Records; Electronic Signatures, Part 11, 21 C.F.R. 2013

92. Geneva: PIC/S Secretariat; 2013. Pharmaceutical Inspection Convention, Pharmaceutical Inspection Co-operation Scheme, International Guide to Good Manufacturing Practice for Medicinal Products, Computerised systems, Annex 11.

93. United States: Office of the Federal Register; 2007. U.S. Department of Health and Human Services. Guidance for Industry-Computerized Systems Used in Clinical Investigations.

94. Brussels: European Commission; 2001. European Commission, Enterprise Directorate-General. Eudralex-EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Qualification and Validation. Vol. 4, Annex 15.

95. Geneva: PIC/S Secretariat; 2013. Pharmaceutical Inspection Convention, Pharmaceutical Inspection Co-operation Scheme, International Guide to Good Manufacturing Practice for Medicinal Products, Qualification and Validation, Annex 15.

96. Brussels: 2001. European Commission, Enterprise Directorate-General. Eudralex-EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Certification by a Qualified Person and Batch Release, Volume 4, Annex 16.

97. Brussels: European Commission; 2001. European Commission, Enterprise Directorate-General. Eudralex-EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Parametric Release. Vol. 4, Annex 17.

98. Geneva: PIC/S Secretariat; 2013. Pharmaceutical Inspection Convention, Pharmaceutical Inspection Co-operation Scheme, International Guide to Good Manufacturing Practice for Medicinal Products, Parametric Release, Annex 17.

99. Geneva: PIC/S Secretariat; 2007. Pharmaceutical Inspection Convention, Pharmaceutical Inspection Co-operation Scheme, Recommendation on Guidance on Parametric Release.

100. London: The European Agency for the Evaluation of Medicinal Product; 2001. Committee for Proprietary Medicinal Products: Note for Guidance on Parametric Release. CPMP/QWP/3015/99.

101. United States: Rockville: 2010. U.S. Department of Health and Human Services. Guidance for Industry, Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes; 2010 February.

102. Brussels: European Commission; 2005. European Commission, Enterprise and Industry Directorate-General. Eudralex-EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Reference and Retention Samples. Vol. 4, Annex 19.

103. Geneva: PIC/S Secretariat; 2013. Pharmaceutical Inspection Convention, Pharmaceutical Inspection Co-operation Scheme, International Guide to Good Manufacturing Practice for Medicinal Products, Reference and Retention Samples. Annex 19.

104. Geneva: ICH Legal Mentions; c2014. [Last cited on 2014 Feb 19]. ICH. Harmonization for Better Health. ICH Quality Guidelines; Quality Risk Management Q9. Available from: http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html .

105. Final Concept Paper; Q9: Quality Risk Management. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use; November 11. 2003

106. Geneva, Switzerland: 2005. ICH Expert Working Group. ICH Harmonized Tripartite Guideline, Quality Risk Management Q9. International Conference of Technical Requirements for Registration of Pharmaceuticals for Human Use; 2005 Nov, 9.

107. London: European Medicines Agency; 2011. Quality Risk Management (ICH Q9). EMA/INS/GMP/79766/2011.

108. United States, Rockville: 2006. ICH Expert Working Group, U.S. Department of Health and Human Services. Guidance for Industry, Q9 Quality Risk Management. International Conference of Technical Requirements for Registration of Pharmaceuticals for Human Use; 2006 June.

109. Geneva: PIC/S Secretariat; 2013. Pharmaceutical Inspection Convention, Pharmaceutical Inspection Co-operation Scheme, International Guide to Good Manufacturing Practice for Medicinal Products, Quality Risk Management, Annex 20.

Никто никогда не называл Джаббу дураком, свиньей - быть может, но дураком -. - Свою женскую интуицию ты ставишь выше ученых степеней и опыта Джаббы в области антивирусного программирования. Она взглянула на него с холодным презрением. Бринкерхофф поднял руки в знак капитуляции.

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