Document Management - GMP Requirements and Best Practice

(Im Auftrag der European Compliance Academy)

Document Management - GMP Requirements and Best Practice <p>(Im Auftrag der European Compliance Academy)

Prague, Czech Republic

Seminar Nr. 9169


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Stephan Dresen,Warner Chilcott Deutschland GmbH/ Actavis PLC Deutschland
Dr Bob McDowall, McDowall Consulting


Learn how to implement, optimise and efficiently establish a GMP-compliant Document Management System through specialised lectures and examples. For this, various possibilities will be presented, like for example management via simple databases, handling of hybrid forms or methods, and full electronic document management.
This will be discussed also in the light of the revised chapter 4 of the EU-GMP Guide and FDA’s emphasis on data integrity under CPG 7346.832.


Documentation is an essential element of every GxP-relevant activity. Indeed, various documents are necessary to define precisely what has to be done, how it has been performed and which results have been created. This gives rise to large quantities of paper and electronic data - which must be reviewed, properly organised and managed efficiently. The new chapter 4 of the EU-GMP Guide requires a „system of documentation“ as part of a Quality Management System (QMS) to ensure the accuracy, the completeness and the proper control of all documents. According to this chapter “Good documentation constitutes an essential part of the quality assurance system and is key to operating in compliance with GMP requirements.”

It must be noted that documents aren’t created for the inspector but for the company to gather comprehensive documentation about its procedures and workflows and also for control and traceability purposes.


This Education Course is directed at all those employees who are responsible for the creation and the management of GMP relevant documents and who are searching for implementation and optimisation possibilities.


An Introduction to Pharmaceutical Documentation
GMP requirements
The implications of EU-GMP Chapter 4
The interface to EU-GMP Chapter 11

Presentation and Discussion of EU GMP Chapter 4 Document Types
Documents in quality control, quality assurance,
manufacturing, IT, engineering
Forms and templates

Definition of Raw Data: what you need to know
EU and FDA requirements
How to define raw data
Data integrity
Raw data management

Efficient Usage of electronic Documentation Management Systems (example Documentum®)
Customisation and user requirements: what do
you really need
Example: SOP-Management

The Management and Storage of Records
Where to store
How to store
Practical implementation and documentation
Paper based system vs. hybrid systems vs. electronic system

Paper - hybrid - electronic: what you need to know
Practical implementation
Paper based system vs. hybrid systems electronic system

Management and Control of multilingual Documents
Part 1: Basics

Part 2: Implementation and Management
GMP status
Change Control

Digital Signatures
Part 1: Basic requirements
When and how to use the various electronic
Technical considerations

Part2: Implementation and Processes

XML –based Document Management
Advantages (single source, compliance, ...)
Challenges (change control, ...)

Workshop: Archiving
External or internal?
Database and search algorithm
How to archive paper


GMP Seminare nach Thema