WORLD TRADE G/TBT/Notif.96.133
21May1996
ORGANIZATION
(96-1928)
Committee onTechnical Barriers toTrade
NOTIFICATION
Thefollowing notification isbeing circulated inaccordance withArticle 10.6.
1. Member toAgreement notifying: UNITED STATES
Ifapplicable, name oflocalgovernment involved (Articles 3.2and7.2):
2. Agency responsible: Food andDrug Administration (51)
Agency orauthority designated tohandle comments regarding thenotification canbe
indicated ifdifferent from above:
3. Notified under Article 2.9.2 [X],2.10.1 [],5.6.2 [],5.7.1 [],other:
4. Products covered (HSorCCCN where applicable, otherwise national tariff heading.
ICSnumbers maybeprovided inaddition, where applicable): Drug products
5. Title, number ofpages andlanguage(s) ofthenotified document: Current Good
Manufacturing Practice; Proposed Amendment ofCertain Requirements forFinished
Pharmaceuticals (12pages)
6. Description ofcontent: TheAdministration isproposing toamend certain requirements
oftheCurrent Good Manufacturing Practice (CGMP) Regulations forfinished
pharmaceuticals. These amendments would clarify certain manufacturing, quality
control, anddocumentation requirements andwould ensure thattherequirements
regulations more accurately encompass CGMP. Inaddition, theAgency isupdating the
requirements forprocess andmethods validation toincorporate guidance previously
issued toindustry andtoreflect current practice.
7. Objective andrationale: Toenhance theintegrity ofthedrugmanufacturing process and
thesafety ofdrugproducts.
8. Relevant documents: 61FR20104, 3May1996; 21CFR Parts 210and211. Will
appear intheFederal Register when adopted.
9. Proposed dateofadoption: TheAdministration proposes thatanyfinalrulethatmay
issue based upon thisproposal become effective 90daysafteritsdateofpublication in
theFederal Register.
Proposed dateofentry intoforce:
10. Final dateforcomments: 1August 1996
11. Texts available from: National enquiry point [X]oraddress andtelefax number ofother
body: