美国fda生产过程(工艺)验证总则指南中英文版.docVIP

GUIDELINE ON GENERAL PRINCIPLES OF PROCESS VALIDATION May, 1987 Prepared by: Center for Drugs and Biologics and Center for Devices and Radiological Health Food and Drug Administration Maintained by: Division of Manufacturing and Product Quality (HFN-320) Office of Compliance Center for Drugs and Biologics Food and Drug Administration 5600 Fishers Lane Rockville General Principles of Process Validation May 1987 GENERAL PRINCIPLES OF PROCESS VALIDATION 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. -1- This guideline may be amended from time to time. Interested persons are invited to submit comments on this document and any subse