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...

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

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

SOP "Technical Agreement and Delimitation of Pharmaceutical Responsibilities"
Standard...

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

GMP Supplier Assessment Questionnaire for Active Pharmaceutical Ingredients (API) 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...

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

This download shows you procedures you can implement now that ensure the successful management...

In this pdf download you'll find answers on how deviations are defined, what must be observed...

This pdf download shows how you can establish an effective CAPA system, which interfaces there...

This download covers all aspects you have to consider when transferring!

incl. an...

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

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

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

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

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...