FDA外用制剂检查指南中英文版.docVIP

GUIDE TO INSPECTIONS OF TOPICAL DRUG PRODUCTS 局部外用药物检查指南 Note: This document is reference material for investigators and other FDA personnel. The document does not bind（进退两难） FDA, and does no confer（赠予） any rights,privileges（特权）, benefits（权益）, or immunities（豁免） for or on any person(s). 注：该指南是FDA 检查官和其他工作人员的参考材料。该指南不是约束FDA，但也不赋予任何人特权，利益或豁免的权利。 I. PURPOSE（目的） The purpose of this guide is to provide field investigators, who are familiar with the provisions（食品） of the Current Good Manufacturing Practice (CGMP) regulations for pharmaceuticals, with guidance on inspecting selected facets（方面） of topical（局部的） 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（无菌的）. However, this guide does not address（介绍） every problem area that the investigator may encounter（碰见）, nor every policy that pertains to（附属） topical drug products. 该指南的目的是向熟悉食品CGMP规程的检察官提供药品CGMP的指导，提供局部外用药物检查方面的指南。该指南中涵盖的内容适用于所有剂型的局部外用药物，包括那些无菌产品。然而，该指南未能介绍检察官可能遇到的每个问题领域，也不适用局部外用药物的每项政策。 II. INTRODUCTION（介绍） This inspectional guide addresses several problem areas that may be encountered in the production of topical drug products potency（效价）, active ingredient uniformity（均一性）, physical characteristics, microbial purity and chemical purity. The guide also addresses problems relating to the growing number of transdermal（经皮吸收） 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. 该检查指南介绍了局部外用药物可能遇到的一些问题，如效价、活性成分的均一