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TOP 5 GMP Downloads

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 in Practice: 24 chapters written by internationally renowned industry experts.


GMP Regulations: 8 chapters with the most important GMP guidelines and regulations.



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Reduce Human Error in a GMP Facility

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


Continuous Manufacturing

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

by Dr. Sabine Paris


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


Principles of blow-fill-seal technology

An excerpt of the GMP MANUAL

by Dr. Manfred Grüneberg


Project management of facility construction

An excerpt of the GMP MANUAL

by Thomas Peither


What you must know about qualification and ATP classification of lorries

by Thomas Peither


Test results outside defined criteria (OOX)

by Dr. Markus Limberger


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

by Thomas Peither

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