Quality Control Training Manual
eBook - PDF

Quality Control Training Manual

Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories

Syed Imtiaz Haider, Syed Erfan Asif

  1. 484 pagine
  2. English
  3. PDF
  4. Disponibile su iOS e Android
eBook - PDF

Quality Control Training Manual

Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories

Syed Imtiaz Haider, Syed Erfan Asif

Dettagli del libro
Indice dei contenuti
Citazioni

Informazioni sul libro

Written to help companies comply with GMP, GLP, and validation requirements imposed by the FDA and regulatory bodies worldwide, Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories presents cost-effective training courses that cover how to apply advances in the life sciences to produce commercially viable biotech products and services in terms of quality, safety, and efficacy. This book and its accompanying downloadable resources comprise detailed text, summaries, test papers, and answers to test papers, providing an administrative solution for management.

  • Provides the FDA, Health Canada, WHO, and EMEA guidelines directly applicable to pharmaceutical laboratory-related issues
  • Offers generic formats and styles that can be customized to any organization and help management build quality into routine operations to comply with regulatory requirements
  • Contains ready-to-use training courses that supply a good source of training material for experienced and inexperienced practitioners in the biotechnology/biopharmaceutical industries
  • Includes downloadable resources with downloadable training courses that can be adopted and directly customized to a particular organization
  • Supplies ready-to-use test papers that allow end users to record all raw data up to the issuance of the attached certificate

The biotechnology/bioscience industries are regulated worldwide to be in compliance with cGMP and GLP principles, with particular focus on safety issues. Each company must create a definite training matrix of its employees. The training procedures in this book enable end users to understand the principles and elements of manufacturing techniques and provide documentation language ranging from the generic to the specific. The training courses on the downloadable resources supply valuable tools for developing training matrices to achieve FDA, Health Canada, EMEA, MHRA UK, WHO, and GLP compliance.

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Informazioni

Editore
CRC Press
Anno
2016
ISBN
9781439850169
Edizione
1
Argomento
Medicine
Categoria
Biotechnology in Medicine

Indice dei contenuti

  1. Front Cover
  2. Contents
  3. Preface
  4. Acknowledgements
  5. Authors
  6. About the Book
  7. Disclaimer
  8. QCT-01 : Analytical Methods, Techniques and Quality Measures for General Pharmaceutical Products
  9. QCT-01.1: Analytical Method Validation and Requirements
  10. QCT-01.2: Laboratory Equipment
  11. QCT-01.2 : Laboratory Equipment
  12. QCT-01.3 : Reference Standards and Reagents
  13. QCT-01.4 - Sample Management
  14. QCT-01.5 - Stability Analytical Methods and Requirements
  15. QCT-01.6 - Microbiological Methods and Analysis
  16. QCT-01.7 - Analytical Failure Investigations
  17. QCT-01.8 - Calibration Program
  18. QCT-01.9 - Laboratory Facility
  19. QCT-01.10 - Products Annual Reviews
  20. QCT-01.11 - Third-Party Testing
  21. QCT-01.12 - Good Documentation Practices
  22. QCT-01.13 - Change Control
  23. QCT-02 - Analytical Methods, Techniques and Quality Measures for Biological Products
  24. QCT-02.1 - Immunoblotting
  25. QCT-02.2 - Gel Permeation Chromatography
  26. QCT-02.3 - Electrophoresis
  27. QCT-02.4 - Ion-Exchange Chromatography
  28. QCT-03 - Laboratory Training Manual
  29. QCT-03.1 - Laboratory Safety and Good Laboratory Practice
  30. QCT-03.2 - Training of Sampling Procedure
  31. QCT-03.3.1 - Training of Conventional Procedures
  32. QCT-03.3.2 - Training of Basic Analytical Techniques
  33. QCT-03.3.3 - Training of Chromatographic Techniques
  34. QCT-03.3.4 - Spectroscopic Techniques
  35. QCT-03.3.5 - Electrochemical Techniques
  36. QCT-03.3.6 - Dissolution Test
  37. QCT-03.3.7 - Miscellaneous Techniques
  38. QCT-04 - Assessment of Training
  39. QCT-04.1 - Assessment Procedure for Chemical Testing
  40. QCT-04.2 - Assessment Procedure for Microbiologist
  41. QCT-05 - Training Assessment with Quiz and Answers
  42. QCT-05.1 - Assessment for Analytical Methods Validation and Requirements
  43. QCT-05.1.1 - Answers to Quiz for Analytical Methods Validation and Requirements
  44. QCT-05.2 - Assessment for Analytical Equipment
  45. QCT-05.2.1 - Answers to Quiz for Analytical Equipment
  46. QCT-05.3 - Assessment for Reference Standards and Reagents
  47. QCT-05.3.1 - Answers to Quiz for Reference Standards and Reagents
  48. QCT-05.4 - Assessment for Sample Management
  49. QCT-05.4.1 - Answers to Quiz for Sample Management
  50. QCT-05.5 - Assessment for Stability Analytical Methods and Requirements
  51. QCT-05.5.1 - Answers to Quiz for Stability Analytical Methods and Requirements
  52. QCT-05.6 - Assessment for Microbiological Methods and Testing
  53. QCT-05.6.1 - Answers to Quiz for Microbiological Methods and Testing
  54. QCT-05.7 - Assessment for Laboratory Investigations
  55. QCT-05.7.1 - Answers to Quiz for Laboratory Investigations
  56. QCT-05.8 - Assessment for Calibration Programme
  57. QCT-05.8.1 - Answers to Quiz for Calibration Programme
  58. QCT-05.9 - Assessment for Laboratory Facility
  59. QCT-05.9.1 - Answers to Quiz for Laboratory Facility
  60. QCT-05.10 - Assessment for Annual Reviews
  61. QCT-05.10.1 - Answers to Quiz for Annual Reviews
  62. QCT-05.11 - Assessment for Third-Party Testing
  63. QCT-05.11.1 - Answers to Quiz for Third-Party Testing
  64. QCT-05.12 - Assessment for Good Documentation Practices
  65. QCT-05.12.1 - Answers to Quiz for Good Documentation Practices
  66. QCT-05.13 - Assessment for Change Control
  67. QCT-05.13.1 - Answers to Quiz for Change Control
  68. QCT-05.14 - Assessment for Immunoblotting
  69. QCT-05.14.1 - Answers to Quiz for Immunoblotting
  70. QCT-05.15 - Assessment for Gel Permeation Chromatography
  71. QCT-05.15.1 - Answers to Quiz for Gel Permeation Chromatography
  72. QCT-05.16 - Assessment for Electrophoresis
  73. QCT-05.16.1 - Answers to Quiz for Electrophoresis
  74. QCT-05.17 - Assessment for Ion-Exchange Chromatography
  75. QCT-05.17.1 - Answers to Quiz for Ion-Exchange Chromatography
  76. QCT-06 - Training Log
  77. QCT-06.1 - General Introduction Training Log
  78. QCT-06.2 - Good Housekeeping and Good Laboratory Practice
  79. QCT-06.3 - Sampling Procedure Training Log
  80. QCT-06.4 - Chemical Testing Training Log
  81. QCT-06.5 - Training Log for Microbiology
  82. QCT-07 - Analytical Method Validation Master Plan
  83. QCT-08 - Analytical Methods Validation Protocol
  84. QCT-09 - SOP for Annual Re-Qualification of HPLC Units
  85. QCT-10 - SOP for Annual Re-Qualification of GC Units
  86. QCT-11 - ABC Pharmaceutical Company
  87. QCT-12 - Regulations
  88. QCT-12.1
  89. QCT-12.1
  90. QCT-12.2
  91. CLV-12.3
  92. QCT-12.4
  93. QCT-12.5
  94. Index
  95. Back Cover
Stili delle citazioni per Quality Control Training Manual

APA 6 Citation

Haider, S. I., & Asif, S. E. (2016). Quality Control Training Manual (1st ed.). CRC Press. Retrieved from https://www.perlego.com/book/1506883/quality-control-training-manual-comprehensive-training-guide-for-api-finished-pharmaceutical-and-biotechnologies-laboratories-pdf (Original work published 2016)

Chicago Citation

Haider, Syed Imtiaz, and Syed Erfan Asif. (2016) 2016. Quality Control Training Manual. 1st ed. CRC Press. https://www.perlego.com/book/1506883/quality-control-training-manual-comprehensive-training-guide-for-api-finished-pharmaceutical-and-biotechnologies-laboratories-pdf.

Harvard Citation

Haider, S. I. and Asif, S. E. (2016) Quality Control Training Manual. 1st edn. CRC Press. Available at: https://www.perlego.com/book/1506883/quality-control-training-manual-comprehensive-training-guide-for-api-finished-pharmaceutical-and-biotechnologies-laboratories-pdf (Accessed: 14 October 2022).

MLA 7 Citation

Haider, Syed Imtiaz, and Syed Erfan Asif. Quality Control Training Manual. 1st ed. CRC Press, 2016. Web. 14 Oct. 2022.