FDA美国食品药物管理局工艺验证指南(英文版)(doc 20页)

FDA美国食品药物管理局工艺验证指南(英文版)内容摘要：
 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.