What Is Meant by Gmp Good Manufacturing Processes

1. Gouveia BG. Lisbon: Lusófona University of Humanities and Technologies; 2013. Good Manufacturing Practices for Medicinal Products for Human Use [dissertation] [Google Scholar]

3. Geneva: PIC/S Secretariat; c2014. [Last update on 2013 Dec 20; Last cited on 2014 Feb 19]. PIC/S. Pharmaceutical Inspection Co-operation Scheme. Available from: http://www.picscheme.org/index.php . [Google Scholar]

6. 2nd ed. Vol. 2. Geneva: WHO Library Cataloguing in Publication Data; 2007. World Health Organization. Quality Assurance of Pharmaceuticals: A Compendium of Guidelines and Related Materials. Good Manufacturing Practices and Inspection; pp. 1–6. [Google Scholar]

7. Geneva: WHO Press; 2011. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Annex 3- WHO Good Manufacturing Practices for Pharmaceutical Products: Main Principles, Introduction. WHO Technical Report Series, No 961, Forty-fifth Report. [Google Scholar]

15. Vol. 4. Brussels: European Commission; 2010. European Commission, Health and Consumers Directorate-General. Eudralex-EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Introduction. [Google Scholar]

20. Silver Spring: FDA; [Last updated on 2013 June 14; Last cited on 2014 Feb 19]. U.S. Food and Drug Administration. What is the difference between the Federal Food, Drug, and Cosmetic Act (FD and CAct), FDA regulations, and FDA guidance? Available from: http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194909.htm . [Google Scholar]

22. Geneva, Switzerland: 2008. ICH Expert Working Group. ICH Harmonized Tripartite Guideline, Pharmaceutical Quality System Q10. International Conference of Technical Requirements for Registration of Pharmaceuticals for Human Use; 2008 June. [Google Scholar]

24. Part 1, Ch. 1. Vol. 4. Brussels: European Commission; 2010. European Commission, Health and Consumers Directorate-General. Eudralex-EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Pharmaceutical Quality System. [Google Scholar]

25. Part I, Ch. 1. Geneva: PIC/S Secretariat; 2013. Pharmaceutical Inspection Convention, Pharmaceutical Inspection Co-operation Scheme. Guide to Good Manufacturing Practice for Medicinal Products, Quality Management. [Google Scholar]

26. 2nd ed. Vol. 2. Geneva: WHO Library Cataloguing in Publication Data; 2007. World Health Organization. Quality Assurance of Pharmaceuticals: A Compendium of Guidelines and Related Materials. Good Manufacturing Practices and Inspection, Quality Management in the Drug Industry; pp. 15–18. [Google Scholar]

27. Geneva: WHO Press; 2011. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Annex 3-WHO Good Manufacturing Practices for Pharmaceutical Products: Main Principles, Quality Management in the Medicines Industry: Philosophy and Essential Elements. WHO Technical Report Series, No 961, Forty-fifth Report. [Google Scholar]

28. Part 1, Ch. 2. Vol. 4. Brussels: European Commission; 2013. European Commission, Health and Consumers Directorate-General. Eudralex-EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Personnel. [Google Scholar]

29. Geneva: WHO Press; 2011. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Annex 3-WHO Good Manufacturing Practices for Pharmaceutical Products: Main Principles, Personnel; Training; Personnel Hygiene. WHO Technical Report Series, No 961, Forty-fifth Report. [Google Scholar]

30. Part I, Ch. 2. Geneva: PIC/S Secretariat; 2013. Pharmaceutical Inspection Convention, Pharmaceutical Inspection Co-operation Scheme. Guide to Good Manufacturing Practice for Medicinal Products, Personnel. [Google Scholar]

31. Current Good Manufacturing Practice for Finished Pharmaceutical, Organization and Personnel, Part 211, Subpart B, 21 C.F.R. 2009 [Google Scholar]

32. Geneva: WHO Press; 2011. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Annex 3-WHO Good Manufacturing Practices for Pharmaceutical Products: Main Principles, Premises, Equipment. WHO Technical Report Series, No 961, Forty-fifth Report. [Google Scholar]

33. Part 1, Ch. 3. Vol. 4. Brussels: European Commission; 1991. European Commission, Health and Consumers Directorate-General. Eudralex-EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Premises and Equipment. [Google Scholar]

34. Part I, Ch. 3. Geneva: PIC/S Secretariat; 2013. Pharmaceutical Inspection Convention, Pharmaceutical Inspection Co-operation Scheme. Guide to Good Manufacturing Practice for Medicinal Products, Premises and Equipment. [Google Scholar]

35. Part 1, Ch. 4. Vol. 4. 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, Documentation. [Google Scholar]

36. Part I, Ch. 4. Geneva: PIC/S Secretariat; 2013. Pharmaceutical Inspection Convention, Pharmaceutical Inspection Co-operation Scheme. Guide to Good Manufacturing Practice for Medicinal Products, Documentation. [Google Scholar]

37. Geneva: WHO Press; 2011. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Annex 3-WHO Good Manufacturing Practices for Pharmaceutical Products: Main Principles, Documentation. WHO Technical Report Series, No 961, Forty-fifth Report. [Google Scholar]

38. Part 1, Ch. 5. Vol. 4. Brussels: European Commission; 1991. European Commission, Health and Consumers Directorate-General. Eudralex-EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Documentation. [Google Scholar]

39. Part I, Ch. 5. Geneva: PIC/S Secretariat; 2013. Pharmaceutical Inspection Convention, Pharmaceutical Inspection Co-operation Scheme. Guide to Good Manufacturing Practice for Medicinal Products, Production. [Google Scholar]

40. Part I, Ch. 6. Geneva: PIC/S Secretariat; 2013. Pharmaceutical Inspection Convention, Pharmaceutical Inspection Co-operation Scheme. Guide to Good Manufacturing Practice for Medicinal Products, Quality Control. [Google Scholar]

41. Geneva: WHO Press; 2011. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Annex 3-WHO Good Manufacturing Practices for Pharmaceutical Products: Main Principles, Good Practices in Quality Control. WHO Technical Report Series, No 961, Forty-fifth Report. [Google Scholar]

42. Part 1, Ch. 6. Vol. 4. 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, Quality Control. [Google Scholar]

43. Part 1, Ch. 7. Vol. 4. Brussels: European Commission; 2013. European Commission, Health and Consumers Directorate-General. Eudralex-EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Outsourced Activities. [Google Scholar]

44. Part I, Ch. 7. Geneva: PIC/S Secretariat; 2013. Pharmaceutical Inspection Convention, Pharmaceutical Inspection Co-operation Scheme. Guide to Good Manufacturing Practice for Medicinal Products, Contract Manufacture and Analysis. [Google Scholar]

45. Geneva: WHO Press; 2011. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Annex 3-WHO Good Manufacturing Practices for Pharmaceutical Products: Main Principles, Contract Production and Analysis. WHO Technical Report Series, No 961, Forty-fifth Report. [Google Scholar]

46. Part 1, Ch. 8. Vol. 4. 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, Complaints and Product Recall. [Google Scholar]

47. Part I, Ch. 8. Geneva: PIC/S Secretariat; 2013. Pharmaceutical Inspection Convention, Pharmaceutical Inspection Co-operation Scheme. Guide to Good Manufacturing Practice for Medicinal Products, Complaints and Product Recall. [Google Scholar]

48. Geneva: WHO Press; 2011. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Annex 3-WHO Good Manufacturing Practices for Pharmaceutical Products: Main Principles, Complaints, Product Recall. WHO Technical Report Series, No 961, Forty-fifth Report. [Google Scholar]

49. Current Good Manufacturing Practice for Finished Pharmaceutical, Complaint files, Part 211, Subpart J, 21 C.F.R. 2009 [Google Scholar]

50. Part 1, Ch. 9. Vol. 4. Brussels: European Commission; 1991. European Commission, Health and Consumers Directorate-General. Eudralex-EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Self Inspection. [Google Scholar]

51. Part I, Ch. 9. Geneva: PIC/S Secretariat; 2013. Pharmaceutical Inspection Convention, Pharmaceutical Inspection Co-operation Scheme. Guide to Good Manufacturing Practice for Medicinal Products, Self Inspection. [Google Scholar]

52. Geneva: WHO Press; 2011. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Annex 3-WHO Good Manufacturing Practices for Pharmaceutical Products: Main Principles, Self-inspection, Quality Audits and Supplier's Audits and Approval. WHO Technical Report Series, No 961, Forty-fifth Report. [Google Scholar]

53. United States: Rockville; 2001. ICH. Expert Working Group, U.S. Department of Health and Human Services. Guidance for Industry, Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. International Conference of Technical Requirements for Registration of Pharmaceuticals for Human Use; 2001 August. [Google Scholar]

55. Geneva, Switzerland: 2000. ICH Expert Working Group. ICH Harmonized Tripartite Guideline, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7. International Conference of Technical Requirements for Registration of Pharmaceuticals for Human Use; 2000 Nov, 10. [Google Scholar]

56. Part 2. Vol. 4. 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, Basic Requirements for Active Substances used as Starting Materials. [Google Scholar]

57. Geneva: WHO Press; 2010. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Annex 2-WHO Good Manufacturing Practices for Active Pharmaceutical Ingredients. WHO Technical Report Series, No 957, Forty-fourth Report. [Google Scholar]

58. Geneva: PIC/S Secretariat; 2013. Pharmaceutical Inspection Convention, Pharmaceutical Inspection Co-operation Scheme, International Conference on Harmonization. Guide to Good Manufacturing Practice for Medicinal Products, Part II. [Google Scholar]

59. Annex 9. Vol. 4. Brussels: European Commission; 1991. European Commission. Eudralex-EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Manufacture of Liquids, Creams and Ointments. [Google Scholar]

60. Geneva: PIC/S Secretariat; 2013. Pharmaceutical Inspection Convention, Pharmaceutical Inspection Co-operation Scheme, International Guide to Good Manufacturing Practice for Medicinal Products, Manufacture of Liquids, Creams and Ointments, Annex 9. [Google Scholar]

61. Annex 1. Vol. 4. 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 Sterile Medicinal Products (corrected version) [Google Scholar]

62. Geneva: PIC/S Secretariat; 2013. Pharmaceutical Inspection Convention, Pharmaceutical Inspection Co-operation Scheme, International Guide to Good Manufacturing Practice for Medicinal Products, Manufacture of Sterile Medicinal Products. Annex 1. [Google Scholar]

63. Geneva: WHO Press; 2011. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Annex 6-WHO Good Manufacturing Practices for Sterile Pharmaceutical Products. WHO Technical Report Series, No 961, Forty-fifth Report. [Google Scholar]

64. Geneva: 1999. Technical Committee ISO/TC 209; International Standard Organization. Cleanrooms and associated environments-Part 1: Classification of air cleanliness. ISO 14644-1:1999. [Google Scholar]

65. United States, Rockville: 2004. U.S. Department of Health and Human Services. Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing-Current Good Manufacturing Practice. Pharmaceutical CGMPs; 2004, September. [Google Scholar]

66. Geneva: 2000. Technical Committee ISO/TC 209; International Standard Organization. Cleanrooms and associated controlled environments-Part 2: Specifications for Testing and Monitoring to Prove Continued Compliance with ISO 14644-1. ISO 14644-2:2000. [Google Scholar]

67. Brussels: European Commission; 2013. European Commission, Health and Consumers Directorate-General. Eudralex-EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Manufacture of Biological active substances and Medicinal Products for Human Use, Vol. 4, Annex 2. [Google Scholar]

68. Geneva: PIC/S Secretariat; 2013. Pharmaceutical Inspection Convention, Pharmaceutical Inspection Co-operation Scheme, International Guide to Good Manufacturing Practice for Medicinal Products, Manufacture of biological medicinal products for human use, Annex 2. [Google Scholar]

69. Geneva: WHO Press; 1992. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Annex 1-WHO Good Manufacturing Practices for Biological Products. WHO Technical Report Series, No 822. [Google Scholar]

70. 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 Radiopharmaceuticals. Vol. 4, Annex 3. [Google Scholar]

71. Geneva: WHO Press; 2003. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Annex 3-Guidelines on Good Manufacturing Practices for Radiopharmaceutical Products. WHO Technical Report Series, No 908, Thirty-seventh Report. [Google Scholar]

72. Geneva: PIC/S Secretariat; 2013. Pharmaceutical Inspection Convention, Pharmaceutical Inspection Co-operation Scheme, International Guide to Good Manufacturing Practice for Medicinal Products, Manufacture of radiopharmaceuticals, Annex 3. [Google Scholar]

73. Brussels: European Commission; 1991. European Commission. Eudralex-EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation. Vol. 4, Annex 10. [Google Scholar]

74. Geneva: PIC/S Secretariat; 2013. Pharmaceutical Inspection Convention, Pharmaceutical Inspection Co-operation Scheme, International Guide to Good Manufacturing Practice for Medicinal Products, Manufacture of Pressurised Metered dose Aerosol Preparations for Inhalation, Annex 10. [Google Scholar]

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. [Google Scholar]

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. [Google Scholar]

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. [Google Scholar]

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. [Google Scholar]

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. [Google Scholar]

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. [Google Scholar]

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. [Google Scholar]

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. [Google Scholar]

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. [Google Scholar]

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. [Google Scholar]

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. [Google Scholar]

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. [Google Scholar]

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. [Google Scholar]

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. [Google Scholar]

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. [Google Scholar]

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. [Google Scholar]

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

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. [Google Scholar]

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. [Google Scholar]

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. [Google Scholar]

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. [Google Scholar]

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. [Google Scholar]

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. [Google Scholar]

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. [Google Scholar]

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

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. [Google Scholar]

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. [Google Scholar]

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. [Google Scholar]

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. [Google Scholar]

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 [Google Scholar]

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. [Google Scholar]

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

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. [Google Scholar]

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. [Google Scholar]

What Is Meant by Gmp Good Manufacturing Processes

Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4399016/

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