Quality Unit

For auditors and manufacturers of drugs and APIs.

More than 650 typical questions...

for the Transport and Storage of Medicinal Products for Human Use, Active Substances and...

GMP-Conform Sampling and Handling of Substances

• regulatory requirements
...

What is the GMP-compliant approach and what do the single steps in the process flow look like?...

A step-by-step guide to bring your drug manufacturing systems into compliance!

Ask your supplier the right questions - this questionnaire will help you!
Standard draft to...

How to Meet the GMP Requirements of Annex 16 EU GMP Guide Batch release is complex and...

A number of different approaches can be taken when it comes to the qualification of analytical...

What has changed compared to the last version? Are there new requirements that did not...

This e-book covers all aspects you have to consider when transferring!

incl. an example...

Nowadays all regulatory authorities focus on data integrity and have their own data integrity...

This SOP helps you to create and describe contracts correctly.
Standard draft to adapt and...

This e-book shows how you can establish an effective CAPA system, which interfaces there are...

SOP "GMP-Questionnaire: Contract Manufacturing / Contract Analysis"
Standard draft to adapt...

This sample document defines framework conditions and processes between contract givers and...

How can occured failures be avoided in the future? Start to treat the root cause, not the...

Various different aspects must be considered in order to transfer documentation management,...

In this e-book you'll find answers on how deviations are defined, what must be observed in...

Introducing and implementing an EBR system requires systematic analysis, definition and...

The introduction of a LDMS has an extremely positive impact on the efficiency and quality of...

Handling packaging materials is a high-risk business because of the danger of mix-ups. Get to...