Biotechnology Facility Design and Process Validation

Biotechnology: Second, Completely Revised Edition

Volumn 3, Issue , 2008, Pages 739-767

  Beatrice, Michael G ^a  

^a CENTER FOR BIOLOGICS EVALUATION AND RESEARCH   (United States)

Author keywords

Biotechnology; Specifications; Utilities; Utility; Validation

Indexed keywords

GENETIC ENGINEERING; SPECIFICATIONS;

FACILITY DESIGNS; PROCESS VALIDATION; UTILITIES; UTILITY; VALIDATION;

BIOTECHNOLOGY;

EID: 84952916718     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9783527620845.ch28     Document Type: Chapter

References (14)

1. AVALLONE, H. (1989), FDA, Talk at the Johnson & Johnson Sterilization Sciences Seminar on Water Quality, June 5, at Piscataway, NJ.
2. BJURSTROM, E. E., COLEMAN, D. (1987), Biopharm, 50-55.
3. CATTEANEO, D. J. (1988), Plant validation acceptance criteria, Pharm. Eng. 8(4), 9-11.
4. 21 CFR, Title 21, Code of Federal Regulations, Subchapter F: Biologies, Parts 600-680.
5. 21 CFR (1992), Title 21, Code of Federal Regulations (United States), Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals, April 1.
6. FDA (1981), Letter to the Pharmaceutical Industry RE: Validation and Control of Deionized Water Systems, August.
7. FDA (1983), Guide to Inspection of Computerized Systems in Drug Processing, Food and Drug Administration, February.
8. FDA (1987a), Guideline on Sterile Drug Products Produced by Aseptic Processing, June.
9. FDA (1987b), Software Development Activities, Food and Drug Administration, July.
10. Federal Register (1976), Vol. 41, No. 106, 22202-22219.
11. Federal Register (1984), Vol. 49, No. 50, 856.
12. Federal Register (1992), Vol. 57, No. 228, 55544-55546.
13. KELTER, S. L. (1988), BioPharm. Manuf. 1(5), 30-37.
14. US PHARMACOPEIA (1990), Vol. XXII, Official from January 1.