美国FDA_外用制剂检查指南（英文）..docVIP

GUIDE TO INSPECTIONS OF TOPICAL DRUG PRODUCTS Note: This document is reference 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). I. PURPOSE The purpose of this guide is to provide field investigators, who are familiar 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 topical drug products, including those that are intended to be sterile. However, this guide does not address every problem area that the investigator may encounter, nor every policy that pertains to topical drug products. II. INTRODUCTION This inspectional guide addresses several problem areas that may be encountered in the production of topical drug products potency, active ingredient uniformity, physical characteristics, microbial purity and chemical purity. The guide also addresses problems relating to the growing number of transdermal products. If a new drug pre-approval inspection is being conducted, then an examination of the filed manufacturing and control data, and correspondence should be accomplished early in the inspection. As with other pre-approval inspections, the manufacturing and controls information filed in the relevant application should be compared with the data used for clinical batches and for production (validation) batches. Filed production control data should be specific and complete. III. POTENCY UNIFORMITY Active ingredient solubility and particle size are generally important ingredient characteristics that need to be controlled to assure potency uniformity in many topical drug products such as emulsions