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GMP Manufacturing

Production
€ 179.00
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€ 213.01
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US$
270.00
GMP in the production process | sanitation | hygiene | environmental monitoring | in-process control | and much more...
190 Pages
ISBN: 978-3-943267-19-8
Excerpt from the GMP MANUAL. Identical with chapter 11.

Table of contents:

A. Sanitation
What is sanitation and who is responsible for it?
B. Personnel hygiene
What are the requirements for working clothing?
C. Production hygiene
What sources of contamination must be taken into consideration in the production sequence?
D. Sanitation programme
What is a sanitation programme?
E. Environmental Monitoring
How can monitoring be prepared, carried out and evaluated?
F. GMP in the Production Process
What quality assurance elements are included in production?
G. Weigh-In
What requirements are made concerning rooms and balances?
H. Identification
Which requirements apply for the identification of containers, equipment and rooms?
I. In-Process Control
What are the in-process control tasks?
J. Prevention of cross-contamination
What are the causes of incidence of cross-contamination?
K. Deviations
How can deviations be dealt with?
L. Reworking
What is the difference between rework, reprocessing and recovery?
M. Warehouse and Logistics
What are the requirements?
N. Transportation
Which are the common ways of transportation?
O. References

full table of contents.pdf

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Technical Requirements

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Dr. Christian Gausepohl, Rottendorf Pharma GmbH, Germany
Paolomi Mukherji, Clarkston Consulting, USA
Dr. Nicola Spiggelkoetter, Consultant, Germany
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