GMP FundamentalsA Step-by-Step Guide
This hand book is a practical and easy to read guideline, giving you a quick and comprehensive overview of the complex world of Good Manufacturing Practice (GMP) without the need of previous acquired knowledge.
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Facilitate your communication with our GMP Glossary!
This booklet helps you to easily compare definitions compiled from official glossaries of:
- the EU GMP Guide
- ICH Guidelines
- WHO Guidelines
- PIC/S Guidelines
- FDA Guidelines
ORDER NOW: GMP Glossary and Abbreviations
Good Manufacturing Practice (GMP)
What is GMP?
GMP 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
- Quality Control or
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. Here 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.
Most official inspection authorities, pharmaceutical companies, suppliers and research institutes have been relying on our publications for more than 15 years.
We provide GMP knowledge
>>> for beginners
>>> for experts
Good Distribution Practice (GDP)
What is GDP?
The wholesale distribution of medicinal products is an important activity in integrated supply chain management. Today's distribution network for medicinal products is increasingly complex and involves many players.
These guidelines lay down approviate tools to assist wholesale distributors ins conducting their activities and to prevent falsified medicines from entering the legal supply chain. Compliance with these guidelines will ensure control of the distribution chain and consequently maintain the quality and the integrity of medicinal products.