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Feliz Natal

A equipe Biotec lhe deseja um

Feliz Natal e Próspero 2010

GMP Manual, Good Manufacturing Practice and Implementation - 9 Binders + Cd-Rom

GMP Manual, Good Manufacturing Practice and Implementation - 9 Binders + Cd-Rom Autor:
Editora: PROPRIO AUTOR - 2007
ISBN: 9783934971554
Área: Ciências Farmacêuticas
N. Páginas: 3000 pags
Valor:
R$9,648,00

Sob Encomenda

Sujeito a disponibilidade na editora/fornecedor.

Prazo de entrega:
Livros nacionais: 30 dias úteis.
Livros importados: 60 dias úteis.


The GMP MANUAL is presented in two parts:
GMP in Practice is written in a concise manner by noted industry experts according to international GMP regulations. Numerous approaches and examples of problem-solving are included. All articles are reviewed by an International Advisory Board and industry experts for accuracy and validity. More than 700 checklists, templates and SOPs examples are included.
GMP Regulations contain important, continuously updated GMP regulations from Europe, USA, Japan, PIC/S, ICH and WHO. Each regulation has a separate index. It provides examples, templates and includes numerous checklists, figures and cross-references.
GMP in Practice
1. Pharmaceutical Quality System (PQS)
2. Personnel
3. Premises
4. Facilities and Equipment
5. Pharmaceutical Water
6. Qualification
7. Process Validation
8. Cleaning Validation
9. Computer System Validation
10. Considerations on Risk Management
11. Production
12. Sterile Production
13. Packaging
14. Laboratory Controls
15. Documentation
16. Research and Development
17. Contractors and Suppliers
18. Inspections
19. Quality Unit
20. Continual Improvement
21. Active and Inactive Ingredients
22. Biologics (empty)
23. Medical Devices
GMP Regulations

A. Empty Register
B. Empty Register
C. EU Directives and Guidelines
D. USA: CFR and FDA Guidelines
E. ICH-Guidelines
F. PIC/S Guidelines
G. GMP of other Regions (this
chapter is supplied on CD-ROM
and online only)
- WHO Guidelines
- Canadian GMP Guidelines
- Japanese Regulations
- Chinese Regulations
H. Information
- GMP Abbreviations
- GMP-Glossary
- Addresses

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