Good Manufacturing Practice (GMP)

What is GMP?

GMP (= Good Manufacturing Practice) protects patients. GMP ensures that they receive medicinal products of uncompromised high quality. Compliance with these quality standards is imperative during the manufacture, processing, packaging and storage of medicinal products. Manufacturing authorisation will be denied to any company that fails to comply with GMP regulations. This is governed all over the world by acts of law, regulations and guidelines issued by government bodies, ministries and international organisations. Their goal is to put safe and effective medicinal products on the market with no harm to the patients.

Anyone who takes part in the production of medicinal products or active pharmaceutical ingredients must comply with GMP regulations, regardless of whether that individual is employed in

• Executive Management
• Quality Management
• Production
• Quality Control or
• Engineering

of a pharmaceutical company or supplier.

Every employee must know, follow and implement GMP regulations. Even small errors can have disastrous consequences. Such incidents can lead to official sanctions ranging from suspending sales or closing down the company, all the way to criminal prosecution of the persons responsible. The great challenge is to be familiar with all requirements, to interpret them correctly and to implement them in a timely fashion.

You can protect yourself with

• proper organisation
• appropriate processes
• correct documentation and
• up-to-date information.

Our publications form the benchmark for GMP information. We know what counts for you when it comes to taking the right steps at all times. With us you will find

• a compilation of the most important laws and guidelines
• a broad-based team of experts from government and industry
• well-founded expert knowledge presented understandably
• tips and pointers for putting the requirements into practise.

Pharmaceutical companies, suppliers and research institutes have been relying on our publications for more than 20 years.

We provide GMP knowledge

>>> FOR BEGINNERS

>>> FOR EXPERTS

GMP Fundamentals – A Step-by-Step Guide

A helpful and easy to read guide which facilitates the entry into the complex world of Good Manufacturing Practice (GMP) and teaches the necessary basics.

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The GMP:Blog

Lots of interesting and up-to-date information about Good Manufacturing Practice.

>>> Have a look at the GMP:Blog!

Everything about Good Manufacturing Practice:

In our GMP Glossary you will find over 1000 official definitions of many important terms used in everyday pharmaceutical practice.

We list terms of the following sources:

• Germany (AMG, AMWHV, ZLG, MPG)
• Switzerland and Austria (HMG, AMBV, MepV and AMBO, AMG, MPG)
• Europe (EU-GMP Guide)
• USA (CFR, FDA)
• International organizations (WHO, PIC/S, ICH, etc.)

 To the Glossary