Quality Unit

More than 650 typical questions related to audits and inspections.
Each question with...

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

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

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

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

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

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

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

incl. an...

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

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

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

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

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

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

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

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

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

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...

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