Guidance for industry : process validation, general principles and practices.

Format:

Book

Government document

Contributor:

Center for Drug Evaluation and Research (U.S.)

Center for Biologics Evaluation and Research (U.S.)

Center for Veterinary Medicine (U.S.)

Language:

English

Subjects (All):

Biologicals--Evaluation.

Biologicals.

Drugs--Testing.

Drugs.

Manufacturing processes--Evaluation.

Manufacturing processes.

Physical Description:

1 online resource (20 unnumbered pages)

Other Title:

Process validation, general principles and practices

Place of Publication:

Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) ; Rockville, MD : Center for Biologics Evaluation and Research (CBER) : Center for Veterinary Medicine (CGMP), [2008]

Notes:

Title from PDF title page (viewed on March 24, 2009).

"Draft guidance."

"November 2008."

Includes bibliographical references (page 20).

OCLC:

316871659