GMP Subjects

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

Planning and constructing cleanrooms is a complex task. Get to know how to successfully get...

GMP-Conform Sampling and Handling of Substances

• regulatory requirements
...

Why are Environmental Risk Assessments necessary? What evaluation phases and methods do exist?...

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

Correctly Implementing GMP and GDP Requirements

Current regulatory requirements...

GMP knowledge for the planning, qualification and...

Regulatory requirements for transport and storage of...

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

Are you not quite sure what a PDE report looks like and would like to take a look inside? Get...

Are you not quite sure what an OEL categorisation looks like and would like to take a look...

Are you not quite sure what an elemental impurities risk assessment...

Do you already know how to proceed after having obtained an...

This e-book lays out the basics of building a four-phase qualification plan - DQ, IQ, OQ and...

A step-by-step guide based on real-world examination experience. Discover how...

A comprehensive step-by-step guide, which covers all aspects of selecting and managing...

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

Step-by-step through the whole qualification process of water treatment systems including...

A qualification serves to prove that equipment is fit for its given purpose. So far, so good....

Do your validation processes meet their specified requirements? This bilingual guide offers an...

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

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

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

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