Validacion de procesos

Guidance for Industry

Process Validation: General
Principles and Practices

DRAFT GUIDANCE

This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to theDivision of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. For questions regarding this draft document contact Brian Hasselbalch or Grace McNally (CDER) 301-796-3286 or 301-796-3279, Christopher Joneckis (CBER)301-827-0373, or Dennis Bensley (CVM) 301-827-6956.

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
Center for Veterinary Medicine (CVM)
November 2008
Current Good Manufacturing Practices (CGMP)

Guidance for Industry

Process Validation: GeneralPrinciples and Practices

Additional copies are available from: Office of Training and Communication Division of Drug Information, HFD-240 Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Avenue Building 51, Room 2201 Silver Spring, MD 20993-0002 (Tel) 301-796-3400 http://www.fda.gov/cder/guidance/index.htm and/or Office of Communication, Training andManufacturers Assistance, HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike Rockville, MD 20852-1448 (Tel) 800-835-4709 or 301-827-1800 http://www.fda.gov/cber/guidelines.htm and/or Communications Staff, HFV-12 Center for Veterinary Medicine Food and Drug Administration 7519 Standish Place, Rockville, MD 20855 (Tel) 240-276-9300http://www.fda.gov/cvm/guidance/published.htm

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
Center for Veterinary Medicine (CVM)
November 2008
Current Good Manufacturing Practices (CGMP)

Contains Nonbinding Recommendations
Draft — Not for Implementation

TABLEOF CONTENTS I. II. III. IV.
A. B.

INTRODUCTION............................................................................................................. 1
BACKGROUND ............................................................................................................... 2
STATUTORY AND REGULATORY REQUIREMENTS FOR PROCESSVALIDATION................................................................................................................... 4
RECOMMENDATIONS.................................................................................................. 6

General Considerations for Process Validation .......................................................................... 6
Specific Stages and Activities of Process Validation in the Product Lifecycle......................... 6
1. Stage 1 – Process Design................................................................................................................. 7
2. Stage 2 – Process Qualification....................................................................................................... 9
3. Stage 3 – Continued Process Verification..................................................................................... 13

V. VI.

CONCURRENT RELEASE OF PERFORMANCE QUALIFICATION BATCHES
........................................................................................................................................... 14
DOCUMENTATION...................................................................................................... 15

VII....