Handbook of pharmaceutical manufacturing formulations: Sterile products volume 6

Handbook of Pharmaceutical Manufacturing Formulations: Sterile Products Volume 6

Volumn , Issue , 2004, Pages 1-355

  Niazi, Sarfaraz K ^a  

^a Pharmaceutical Scientist Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 85055932517     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Book

References (29)

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2. Ljungqvist, B. and Reinmuller, B., Clean Room Design: Minimizing Contamination Through Proper Design. Interpharm Press, Buffalo Grove, IL, 1997.
3. NASA Standard for Clean Room and Work Stations for Microbially Controlled Environment. Publication NHB 5340.2, August 1967.
4. Clinical sepsis and death in a newborn nursery associated with contaminated medications — Brazil, 1996. Morbidity and Mortality Weekly Report, 47(29): 610-612, 1998.
5. Grandics, P., Pyrogens in parenteral pharmaceuticals. Pharmaceutical Technology, April 2000.
6. Lord, A. and Levchuk, J.W., Personnel issues in aseptic processing. Biopharm, 1989.
7. Current Practices in the Validation of Aseptic Processing. Technical Report No. 36, Parenteral Drug Association, Inc., Bethesda, MD, 2002.
8. Leahy, T. J. and Sullivan, M.J., Validation of bacterialretention capabilities of membrane filters. Pharmaceutical Technology, November 1978.
9. Pall, D. B. and Kirnbauer, E.A. et al. Particulate Retention by Bacteria Retentive Membrane Filters, Vol. 1. Elsevier, Amsterdam, pp. 235-256, 1980.
10. Sterilizing Filtration of Liquids. Technical Report No. 26, Parenteral Drug Association, Inc., Bethesda, MD, 1998.
11. Commentary on the Sterility Tests and Sterilization Chapters of the U.S. Pharmacopoeia. Pharmacopoeial Forum, July–August 1980, p. 354. Aubrey S. Out-schoorn, Sr. Scientist, U.S.P. Drug Standards Division.
12. Price, J., Blow-fill-seal technology. Part I: A design for particulate control. Pharmaceutical Technology, February 1998.
13. United States Pharmacopoeia, The U.S. Pharmacopoeia Convention, Rockville, MD.
14. Guidance for the Submission of Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Product, 1994.
15. Guideline for Validation of Limulus Amebocyte Lysate Test as an End Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices, 1987.
16. Guide to Inspections of Lyophilization of Parenterals, 1993.
17. Guide to Inspections of High Purity Water Systems, 1993.
18. Guide to Inspections of Microbiological Pharmaceutical Quality Control Laboratories, 1993.
19. Guide to Inspections of Sterile Drug Substance Manufacturers, 1994.
20. Pyrogens: Still a Danger, 1979 (Inspection Technical Guide); Bacterial Endotoxins/Pyrogens, 1985 (Inspection Technical Guide).
21. Heat Exchangers to Avoid Contamination, 1979 (Inspection Technical Guide).
22. Guidance for Industry: Container and Closure Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products, 1999.
23. Compliance Policy Guide 7132a.13: Parametric Release of Terminally Heat Sterilized Drug Products, 1987.
24. Compliance Policy Guide 7150.16: Status and Responsibilities of Contract Sterilizers Engaged in the Sterilization of Drugs and Devices, 1995.
25. Compliance Program CP7346.832: Pre-Approval Inspections/Investigations, 1994.
26. Compliance Program CP7346.843: Post-Approval Audit Inspections, 1992.
27. Compliance Program CP7346.002A: Sterile Drug Process Inspections, Foreign Inspection Guide, 1992.
28. Laboratory Inspection Guide, 1993.
29. Cleaning Validation Inspection Guide, 1993.