Guidance for industry : analytical procedures and methods validation, chemistry, manufacturing, and controls documentation.

Format:

Book

Government document

Contributor:

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

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

Language:

English

Subjects (All):

Drugs--Testing--Documentation--United States.

Drugs.

United States.

Physical Description:

1 online resource (33 pages)

Other Title:

Analytical procedures and methods validation, chemistry manufacturing, and controls documentation

Place of Publication:

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2000]

Notes:

"Draft guidance."

"CMC #."

"August 2000."

Includes bibliographical references (pages 30-31).

OCLC:

558594862