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Reading Samples

See for yourself how GMP MANUAL provides you with state-of-the art GMP know-how that will simplify your daily business!

 

Table of contents

>>> full table of contents

 

Reading Samples
"GMP in Practice"

1.B The road to a pharmaceutical quality system

 

Extract: 7.A Process Validation - Official Requirements

 

Extract: 18.H Questionnaire for preparing GMP inspections

 

19.B.3 The qualified person - Qualification and Experience

 

21.A.11 GMP for APIs - Laboratory Controls

 
 
Advantage for you

Reasons to buy the GMP MANUAL:

#1 Benchmark your procedures


#2 Regulations and Interpretations in one convenient source

 

#3 The only current GMP knowledge source that has THE AUTHORITY

 

#4 More than 10,000 satisfied users around the globe

 

#5 Training Material

 

more advantages ...

 
 
Customers Opinion

Recommended by PDA (Parenteral Drug Association):

 

"... The GMP MANUAL occupies a spot in my bookcase and I often have the occasion to refer to it. If you are a professional in the field of GMP and regulatory compliance, you may find it should be in your bookcase too."

Bob Dana, Sen. VP Regulatory Affairs

 

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GMP in general

GMP MANUAL
The GMP MANUAL is presented in two parts: GMP in Practice and GMP Regulations

9 binders and/or CD-ROM

 
 
Site Master File - Sample for Download
Instructions for preparing a Site Master File according to PIC/S PE 008-4

 
 
GMP for APIs
ICH Q7
combined with
APIC/Cefic "How to do" Document

 
 
 
Systems Based Inspection for Pharmaceutical Manufacturers
A must read for anyone involved in any way with the pharmaceutical inspection process

 
 
 
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