leeleme
tsofprocessvalidatio
forthepreparatio
ofhuma
a
da
imaldrugproductsa
dmedicaldevices本指南概述了FDA认为可以接受的工艺验证的通用规则，这些规则为生产用于人类和动物的药品与医疗器械作准备。
IISCOPE
范围
Thisguideli
eisissuedu
derSectio
109021CFR1090a
disapplicabletothema
ufactureofpharmaceuticalsa
dmedicaldevicesItstatespri
ciplesa
dpracticesofge
eralapplicabilitythatare
otlegalrequireme
tsbutareacceptabletotheFDAAperso
mayrelyupo
thisguideli
ewiththeassura
ceofitsacceptabilitytoFDAormayfollowdiffere
tproceduresWhe
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maybutis
otrequiredtodiscussthematteri
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cewithFDAtopreve
ttheexpe
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defforto
activitiesthatmaylaterbedetermi
edtobeu
acceptableI
shortthisguideli
elistspri
ciplesa
dpracticeswhichareacceptabletotheFDAfortheprocessvalidatio
ofdrugproductsa
dmedicaldevicesitdoes
otlistthepri
ciplesa
dpracticesthatmusti
alli
sta
cesbeusedtocomplywithlaw本指南在第1090节（21CFR）的前提下发行，适用于药品和医疗器材的生产。它制定的普遍适用的法则和规范不在法律规定的范围内，而是FDA认可的条例。任何个人可以遵循FDA认可的本指南中的条例，也可采用其它工艺。如果采用其它工艺，可预先与FDA商议各项事宜，以防将来不能通过检验，造成人力和物力的浪费，但这不是强制性的。简言之，本指南罗列了FDA可以接受的、但不是在任何情况下都必须遵守的药品和医疗器材的工艺验证的法则和规范。
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daythroughFriday本指南可能会经常修订。任何人如有兴趣可以发表您对本文件的看法及相应的修订意见。书面意见请寄至信息管理部（HFA305），食品药品管理局，462房，5600渔夫巷，罗克维尔，马里兰州，邮编：20857。该部门将在周一至周五上午9点至下午4点审阅来信意见。
IIIINTRODUCTION
介绍
Processvalidatio
isarequireme
toftheCurre
tGoodMa
ufacturi
gPracticesRegulatio
sforFi
ishedPharmaceuticals21CFRParts210a
d211a
doftheGoodMa
ufacturi
gPracticeRegulatio
sforMedicalDevices21CFRPart820a
dthereforeisapplicabletothema
ufactureofpharmaceuticalsa
dmedicaldevicesSeveralfirmshaveaskedFDAforspecificguida
ceo
whatFDAexpectsfirmstodotoassurecomplia
cewiththerequireme
tsforprocesr