FDA美國食品藥物管理局工藝驗證指南(英文版)(doc 20頁)

FDA美國食品藥物管理局工藝驗證指南(英文版)內容摘要：
I. PURPOSE
This guideline outlines general principles that FDA considers to be
acceptable elements of process validation for the preparation of
human and animal drug products and medical devices.
II. SCOPE
This guideline is issued under Section 10.90 (21 CFR 10.90) and is
applicable to the manufacture of pharmaceuticals and medical
devices. It states principles and practices of general
applicability that are not legal requirements but are acceptable to
the FDA. A person may rely upon this guideline with the assurance
of its acceptability to FDA, or may follow different procedures.
When different procedures are used, a person may, but is not
required to, discuss the matter in advance with FDA to prevent the
expenditure of money and effort on activities that may later be
determined to be unacceptable. In short, this guideline lists
principles and practices which are acceptable to the FDA for the
process validation of drug products and medical devices; it does
not list the principles and practices that must, in all instances,
be used to comply with law.
This guideline may be amended from time to time. Interested
persons are invited to submit comments on this document and any
subsequent revisions. Written comments should be submitted to the
Dockets Management Branch (HFA-305), Food and Drug Administration,
Room 4-62, 5600 Fishers Lane, Rockville, Maryland 20857. Received
comments may be seen in that office between 9\a.m. and 4\p.m.,
Monday through Friday.

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