Guideline list and search

Content

In this database we have collected all the bodies of regulations, guidelines and commentaries on GMP that we consider important. We have listed the official source for each document. The guidelines can be ordered there or via their internet addresses (any existing links are given). Many guidelines are available free of charge!
So don't let yourself be bamboozled by dubious sources wanting to sell you these free-of-charge guidelines for as much as EUR 100.00.

Some interest groups such as IPEC, PDA and ISPE ask a small fee to cover the printing costs. These guidelines should be ordered directly from these interest groups. Their addresses are also listed. The same applies to commentaries and literature which we have also listed where we consider this necessary in the GMP environment.

Please bear in mind that not all the guidelines are published in English!

How it works

Enter the "Keyword" above and click "Search". Hint: You can find the guidelines you want via the following search terms:

Search via lawmaker: FDA, EC....

Search via product: active, sterile, solid, liquid, biotechnology, medicinal product, cosmetics.

Search via subject group: GMP, engineering, computers, marketing authorization, validation, quality control.

Please do not use compound terms such as computer validation, sterile manufacture, process validation. In the second step you can search for detailed terms such as water, analysis or similar.

You can also search for the organization which issues the guideline. Search words may be: EC, EN standard, CPMP, FDA standard, ISO standard, PIC, ICH, WHO, APV, IKW, Eucomed, PDA, ISPE, IPEC, CEFIC, VFA.
As the search result you will obtain a list containing the guidelines found. Just click one of the guidelines and you will be shown the source from which it can be obtained. If the guideline can be obtained via an internet address (e.g. FDA guidelines) we give the link to the source.

Note

We have chosen the headings printed below in order to have a system. This means that the documents in our database under the heading "FDA guidelines" do not automatically have to have been assigned this term by the FDA but have the character of an FDA recommendation.

For instance you will find the FDA recommendations quickly and easily irrespective of which center at the FDA issued the document (e.g. as a guide, guidance or without designation). If you already know the exact name of the document you can also search for it.