Courtesy of our extensive regulatory database, we are currently compiling a series of compliance Guidance Documents, which will present the mounds of regulatory information available under logical subject matter headings. Each guide will contain all the pertinent references from:

directives and regulations, which tell us what we all have to comply with

guidance information, which tells the regulators and industry how they should be interpreted

FDA 483 Inspectional Observations, Establishment Inspection Reports and Warning Letters, which tell us how the regulators themselves actually interpret all this information.

Currently there are two available. These are free to download, and there are more to follow. Simply click next to the title you are interested in to download a PDF version of the document.

Cleaning Processes and Cleaning Validation > CLICK HERE <