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Értesítés a kedvenc témákról
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GMP Audits in Pharmaceutical and Biotechnology Industries

 
Kiadás sorszáma: 1
Kiadó: CRC Press
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Rövid leírás:

This user-friendly volume presents a basic knowledge on how to perform an audit or inspect a facility and meets all the needs of the audience. It is a key reference source for those training as auditors in organizations that follow FDA, EMA, MHRA, WHO, TGA, PIC/S regulations.

Hosszú leírás:

The fact that GMP audits in the pharmaceutical and biotechnology industries have to be evaluated and with very limited resources has created a gap in this field. The lack of trained and qualified GMP auditors is on the rise in all organizations which are required to implement FDA, EMA, MHRA, WHO, TGA, PIC/S regulations. This volume is an essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits.The author also provides useful tips and a selection of samples about GMP audits that are indispensable for professionals and health inspectors working in industry and health authorities.


Features




  • An essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits.



  • Anyone working in the manufacturing sector needs to be aware of GMP, be able to identify operational flaws as well as legal violations, and have a clear understanding of how to meet GMP standards.

  • Assists the readers in understanding the importance of GMP and how they can apply each aspect in their working environment.



  • Covers a global regulatory landscape.



  • Suitable for relevant degree courses including industrial pharmaceutics and pharmaceutical biotechnology.

Tartalomjegyzék:

Dedication


Preface


Author Biography


Abbreviation


Chapter 1 - The Concept of Quality


Chapter 2 - GMP Audits


Chapter 3 - GMP Auditing in Various Areas


Chapter 4 - Auditing Pharmaceutical Quality Management System


Chapter 5 - Alternative Auditing Methods


Chapter 6 - Audit Question Examples



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