FDA外用制剂检查指南.docVIP

GUIDE TO INSPECTIONS OF TOPICAL DRUG PRODUCTS Note: This document is referenee material for investigators and other FDA personneL The document does not bind FDA, and does no confer any rights, privileges, benefits, or immunities for or on any person(s). PURPOSE The purpose of this guide is to provide field investigators, who are familial with the provisions of the Current Good Manufacturing Practice (CGMP) regulations for pharmaceuticals, with guidance on inspecting selected facets of topical drug product production. The subjects covered in the guide are generally applicable to all forms of to