Quality Unit

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

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

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

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

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

incl. an example...

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

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

This e-book shows you procedures you can implement now that ensure the successful management...

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

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

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

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,...

The deployment of human resources must be carefully planned and organised. In order to assist...

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

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

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

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

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

For auditors and manufacturers of drugs and APIs.

More than 650 typical questions...