Quality control and assurance from the development to the production of biopharmaceuticals

Trends in Biotechnology

Volumn 17, Issue 7, 1999, Pages 266-270

  Doblhoff Dier, Otto ^a   Bliem, Rudolf ^b  

^a UNIVERSITY OF AGRICULTURAL SCIENCES   (Austria)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

BIOTECHNOLOGY; CONSUMER; DOCUMENTATION; DRUG MANUFACTURE; ETHICS; GOOD MANUFACTURING PRACTICE; PRIORITY JOURNAL; QUALITY CONTROL; RECOMBINANT DNA TECHNOLOGY; REGULATORY MECHANISM; REVIEW; SAFETY;

DRUG DESIGN; DRUG INDUSTRY; EUROPE; GUIDELINES; QUALITY CONTROL; REPRODUCIBILITY OF RESULTS; UNITED STATES;

EID: 0033168756     PISSN: 01677799     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0167-7799(99)01314-1     Document Type: Review

References (30)

1. Federal Food, Drug, and Cosmetic Act, United States Code of Federal Regulations (CFR). 1998;. Title 21.
2. Kennedy C.M. Pharm. Technol. Eur. 7:1995;23-30.
3. Haase M. Pharm. Technol. Eur. 7:1995;28-36.
4. Federici M.M. Biologicals. 22:1994;151-159.
5. Guidelines for Research Involving Recombinant DNA Molecules. 1998.
6. Recombinant DNA Safety Considerations for Industrial, Agricultural and Environmental Applications of Organisms Derived by rDNA Techniques. 1986;OECD, Paris, France.
7. Off. J. Eur. Commun. L117:1990;1-14.
8. Off. J. Eur. Commun. L117:1990;15-27.
9. Off. J. Eur. Commun. L374:1990;1-12.
10. Bhatt V. Pharm. Technol. Eur. 8:1996;32-47.
11. Hill D., Beatrice M. Biopharm. Manuf. 2:1989;20-26.
12. Hill D., Beatrice M. Biopharm. Manuf. 2:1989;28-32.
13. Williams R.L. BioPharm. 100:1997;44-50.
14. Morgan J.L., Chew N.J. BioPharm. 9:1996;26-30.
15. Lelieveld H.L.M. J. Soc. Dairy Technol. 38:1985;14-16.
16. Vranch S.P. Ann. New York Acad. Sci. 646:1991;367-375.
17. Chisti Y., Moo Young M. J. Ind. Microbiol. 13:1994;201-207.
18. Fourman G.L., Mullen M.V. Pharm. Technol. Int. 5:1993;46-49.
19. Riggin A., David G.C., Copmann T.L. BioPharm. 9:1996;36-41.
20. Darling A.J., Spaltro J.J. BioPharm. 9:1996;42-50.
21. Sito A.F. J. Cell. Biochem. 17A(Suppl.):1993;46-49.
22. Jeffcoate S. Trends Biotechnol. 14:1996;121-124.
23. Freeman M., Leng M., Morrison D., Munden R.P. Pharm. Technol. Eur. 7:1995;40-46.
24. Paliwal S.K., Nadler T.K., Regnier F.E. Trends Biotechnol. 11:1993;95-100.
25. Trends Food Sci. Technol. 3:1992;325-328.
26. Kletz T.A. HAZOP and HAZAN: Identifying and Assessing Process Industry Hazards. 1992;Hemisphere Publishing Corporation, New York, NY, USA.
27. Akers J., McEntire J., Sofer G. Biopharm. Manuf. 7:1994;40-43.
28. Akers J., McEntire J., Sofer G. Biopharm. Manuf. 7:1994;54-56.
29. Steuer A., Ostrove J.A. BioPharm. 9:1996;40-44.
30. Wright P. Pharm. Technol. Eur. 8:1996;26-32.