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1. Quality Agreement
Defines framework conditions and processes between contract givers and contract acceptors in order to meet mandatory quality criteria.

 

2. GDP Audit Checklist
More than 700 questions with reference to regulations for preparing and carrying out GDP audits.

 

3. GMP Audit Checklist
The GMP Audit Checklist works great for both sides - the auditor and the inspected company.

 

4. Technical Agreement
and Delimination of Pharmaceutical Responsibilities.

 

5. A Process Approach to Pharmaceutical Quality Systems
A Guide to ICH Q10 Compliance

 

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GMP LOGFILE Features

2015-05-27

Advantages of laboratory data management systems (LDMS)

An excerpt of the GMP MANUAL

by Dr. Ulf Fuchslueger

 
2015-05-06

Types of Biotechnological Active Substances

An excerpt of the GMP MANUAL

by Dr. Rainer Gnibl

 
2015-04-15

Reduce Human Error in a GMP Facility

by Claire Newcombe, Applied Biopharm Consultancy, Shanon McKenna , PAREXEL, Anthony Newcombe, PhD, PAREXEL

 
2015-04-09

Continuous Manufacturing

– the FDA perspective on the future of medicinal product manufacturing –


by Dr. Sabine Paris

 
2015-03-25

Preventing Cross-Contamination

In a highly acclaimed talk held during our GMP Symposium, Richard Denk elucidated the risk factors for contamination and the influence of highly active substances.


by Susanne Sailer

 
2015-03-11

Principles of blow-fill-seal technology

An excerpt of the GMP MANUAL


by Dr. Manfred Grüneberg

 
2015-02-25

Project management of facility construction

An excerpt of the GMP MANUAL


by Thomas Peither

 
2015-02-11

What you must know about qualification and ATP classification of lorries

by Thomas Peither

 
2015-01-28

Test results outside defined criteria (OOX)

by Dr. Markus Limberger

 
2015-01-14

GMP-Outlook 2015: What to expect in the world of GMP?

by Thomas Peither

 
2014-11-19

GMP-Compliant Documentation

An excerpt from the GMP MANUAL

by Cornelia Wawretschek

 
2014-11-12

GMP Certificates for API Manufacturers

An excerpt from the GMP MANUAL

by Dr. Stefan Kettelhoit

 
2014-10-29

EDMF/ASMF and CEP

An excerpt from the GMP MANUAL

by Dr. Stefan Kettelhoit

 
2014-10-15

Safety in the workplace / Occupational health and safety

An excerpt from the GMP MANUAL

by Dr. Michael Hiob

 
2014-09-03

Integrated Quality Risk Management

An excerpt from the GMP MANUAL

by Martin Mayer

 
 
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