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TOP 5 GMP Downloads

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


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


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


4. Creating a Master Plan for Drug Warehousing, Transportation and Distribution
Guide to preparing a company for compliance with Good Distribution Practice (GDP).


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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Older Pharmaceutical Factories – What does the FDA have to say?

by Thomas Peither


GMP MANUAL Update 22

Short Summary of the updated chapter 3.B
on material flow, personnel flow and layout of premises

by Andreas Nuhn


Quality Metrics - Bane or Boon?

by Thomas Peither


Risk Evaluation - more than just data and facts

An excerpt from the PDA/DHI publication Risk Assessment and Risk Management in the Pharmaceutical Industry - Clear and Simple

by James L. Vesper


General principles of hygienic design

An excerpt of the GMP MANUAL

by Richard Denk


Cleaning Engineering: Flow and Coverage in Process Piping

An excerpt from the PDA/DHI publication Cleaning and Cleaning Validation

by George Verghese and Paul Lopolito


Reverse osmosis also allowed for future WFI production

An interview with Ruven Brandes

by Dr. Sabine Paris


Advantages of laboratory data management systems (LDMS)

An excerpt of the GMP MANUAL

by Dr. Ulf Fuchslueger


Types of Biotechnological Active Substances

An excerpt of the GMP MANUAL

by Dr. Rainer Gnibl


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

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