Quality Management

GMP-Conform Sampling and Handling of Substances

• regulatory requirements
...

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

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

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

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

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

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...

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...

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...