文档介绍：FDA工艺验证指南
GUIDELINE
ON GENERAL PRINCIPLES OF ROCESS 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 pliance
Center for Drugs and Biologics
Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857
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 (21 CFR ) 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 eptable. 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 ply with law.
This guideline may be amended from time to time. Interested persons are invited to ments on this document and any subsequent revisions. ments should be submitted to the Dockets Management Branch (HFA-305), Food and Drug Administration, Room 4-62, 5600 Fishers Lane, Rockville, Maryland 20857. ments may be seen in that office between 9\. and 4\., Monday through Friday.
III. INTRODUCTION
Process validation is a requirement of t