Biopharmaceutical Process Validation (Biotechnology and Bioprocessing Series)
Edition: 1 edition
Publisher: CRC
Published: March 24, 2000
Language: eng
Format: Hardcover
Number of pages: 402
ISBN-13: 9780824702496
Subjects: Pharmaceutical technology; Pharmacology; Pharmaceutical biotechnology; Medical; Medical / Nursing; Biotechnology; Pharmacy; Science / Biotechnology; Quality Control
First sentence: "Process validation" is defined by the U.S. Food and Drug Administration (FDA) as "establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes" (1).