Docket Management
Docket: 00D-1418 - Q7a ICH Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
Comment Number: EC -12

Accepted - Volume 1

Comment Record
Commentor Dr. Thomas Zwier Date/Time 2000-10-02 08:53:34
Organization Pharmacia Corporation
Category Company

Recommended Changes / Reasons
Lines: 1232-1234
Section: 12.80
In this section it is stated that analytical methods in the current edition of official pharmacopoeia are considered validated. Does this mean that FDA will consider an analytical method in the current European Pharmacopoeia or Japanese Pharmacopoeia to be validated?
Recommended Change Type: General Comments To clarify the scope of the the reference to official compendia and validated analytical methods.

EC -12