GUIDELINE ON GENERAL PRINCIPLES OF PROCESS VALIDATION

I. PURPOSE
II. SCOPE
III. INTRODUCTION
IV. GENERAL CONCEPTS
V. CGMP REGULATIONS FOR FINISHED PHARMACEUTICALS
VI. GMP REGULATION FOR MEDICAL DEVICES
VII. PRELIMINARY CONSIDERATIONS
VIII. ELEMENTS OF PROCESS VALIDATION
A. Prospective Validation
1. Equipment and Process
a. Equipment: Installation Qualification
b. Process: Performance Qualification
c. Product: Performance Qualification
2. System to Assure Timely Revalidation
3. Documentation
B. Retrospective Process Validation
IX. ACCEPTABILITY OF PRODUCT TESTING
GUIDELINE ON 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.
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.