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GMP Compliant Documentation
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GMP Documentation

GMP Compliant Documentation
€ 129.00
€ 153.51
  19% VAT included
How to create, organize, review and archive GMP related documents in pharmaceutical industries
Edition: 1st edition 2013
45 Pages
ISBN: 978-3-943267-50-1
Documentation is the systematic utilisation of information in documents for business purposes and as such a component of the pharmaceutical assurance system. Generally, two types of documents may be distinguished: documents that describe requirements and documents that record activities and their results.

The authors give an overview on GMP-relevant documents and their contents.

The requirements of US GMP regulations are dealt with in a separate chapter. Another focus is set on document management and especially on electronic document management systems.

A large part of the chapter is dedicated to the process of creating documents, with special regard to quality features and formal aspects of good documentation. Signatures and electronic signatures are of key importance for the approval of documents and are therefore discussed in detail. Organising systems for controlling and monitoring documents are presented and the life cycle of documentation is examined.
Handling of copies and archiving of documents are additional aspects that are discussed in this very comprehensive overview on the topic of documentation.

You'll find answers to the following questions:

- What legal requirements exist in relation to the documentation?
- Which documents are relevant to GMP?
- What is required of document management systems?
- How should documents be created, controlled and monitored?
- How should documents be archived?

Table of Contents

1 Basic Principles of Documentation
2 GMP-relevant Documents
3 Requirements of the US GMP Regulations
4 Document Management System
5 Creating Documents
5.1 Quality Features of Good Documentation
5.2 Format and structure of documents
5.3 Revising Documents
5.4 Signatures and Electronic Signatures
6 Controlling and monitoring documents
6.1 Organising systems
6.2 Life cycle of documents
6.3 Handling document copies
6.4 Compliance
6.5 Archiving

Please note: This document is an excerpt from the GMP MANUAL.

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Technical Requirements

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Dr. Michael Hiob, Ministry for Health of Land Schleswig-Holstein, Germany
Dr. Ralph Gomez, Consultant, USA
GMP Audit Checklist (Download)
A Process Approach to Pharmaceutical Quality Systems
Quality Agreement