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GMP Pocket Guides

GMP for APIs
€ 25.00
€ 26.75
  7% VAT included
spiral bound
combined with
APIC/Cefic "How to do" Document
Edition: 2nd edition 2012
190 Pages
Format: 140 x 105 mm

ISBN: 978-3-943267-29-7
GMP Pocket Guide Volume 1
Excerpt from the GMP MANUAL

The ICH Q7 is the most important GMP guideline for active pharmaceutical ingredients manufacturers worldwide.

As an interpretation aid the CEFIC/APIC published a “How to do” Document. This document, developed by experts of the European industry, describes generally accepted solutions, helps to interpret recommendations and shows how to approach the implementation of requirements.

We have editorially combined the recently updated text of the “How to do” Document (August 2012) with the ICH Q7 Guideline, to provide you with a valuable interpretation tool directly related to the regulatory text.

Table of Contents
1 Introduction
2 Quality Management
3 Personnel
4 Buildings and Facilties
5 Process Equipment
6 Documentation and Records
7 Materials Management
8 Production and In-Process Controls
9 Packaging and Identification Labelling of APIs and Intermediates
10 Storage and Distribution
11 Laboratory Controls
12 Validation
13 Change Control
14 Rejection and Re-use of Materials
15 Complaints and Recalls
16 Contract Manufacturers (including Laboratories)
17 Agents, Brokers, Traders, Distributors, Repackers, and Relabellers
18 Specific Guidance for APIs Manufactured by Cell Culture/Fermentation
19 APIs for Use in Clinical Trials
20 Glossary

Reading Sample

Click & View: GMP Pocket Guide Volume 1
Are you looking for a great giveaway for your clients and staff? Starting with as little as 50 copies you can get your corporate edition!

For more information, please contact Ms. Annette Crawford
GMP Glossary and Abbreviations
Creating a Master Plan for Drug Warehousing, Transportation and Distribution
Quality Agreement