A service provided
by the European
Compliance Academy

The CD-ROM contains 630 Mb of GMP-related Guides from various authorities (EU, FDA, ICH, PIC/S etc.). All in all the CD-ROM contains 16,112 pages. All documents together would have a height of about 322.2 cm in total.

In order to search all documents on the CD e.g. for all requirements regarding process validation, you need 3 seconds. Then you will be shown 117 Guides, recommendations and interpretations (e.g. FDA Warning Letters).

1. Find key words in one document.
   This function is useful if you want to identify certain requirements in a Guide. Suppose you want to find out where exactly the FDA guide to inspection of high purity water systems defines design requirements on material - just search for 'material' and the relevant pages appear.

2. Search in all documents
   If your question is:
   "Which Guides define requirements on pharmaceutical water systems?", just use the overall search function and type in 'water system'.

The result

You will get a list of Guidelines which contain the keyword. You can open the files and jump directly to the relevant page. But more than this. You will also find interpretations like presentations of FDA investigators or Warning Letters issued by the FDA.