Human Drug CGMP Notes

These documents have been and still are issued by the FDA. Each document contains a number of questions and “unofficial” FDA answers. They cover a variety of topics, among them cleaning validation.

Cleaning Validation Technologies has selected those questions (and answers) that are applicable, either directly or indirectly, to cleaning validation. The issue date and the topic are listed below. Click on a date to see the entire question and answer.

Please note that each “Human Drug CGMP Notes” contains many more questions than are listed on this site. These are only selected sections that deal with cleaning validation issues. In each case where the question and answer are presented, no editing has been done except for the format. For key decisions, it is recommended that the original file or document be consulted.