ГОСТ Р ИСО 13408-3—2011
Библиография
[1J ИСО 9000:2005
(2) ИСОЯС 11139:2006
(3) ИСО 13485:2003
Quality management systems — Fundamentals and vocabulary
Sterilization of health care products — Vocabulary
Medical devices — Quality management systems — Requirements for regulatory purposes
(4)U.S. Food and Drugs Administration, 21 CFR Part 210 and 211. Current Good
Manufacturing Practices for Finished Pharmaceuticals
(5)U.S. Food and Drugs Administration, 21 CFR Part 11, Electronic records, electronic
signature
(6)U.S. Food and Drugs Administration. Guideline on the general Principles of Process
Validation, May 1987
17)U.S. Food and Drugs Administration. Guide to Inspections of Lyophllization of Parenterals.
15.02.01
)8) EEC Guide to Good Manufactunng Practice for Medicinal Products, Annex 1. Manufacture
of Sterile Medicinal Products
(9) ISPE, GAMP 4.0. Good Automated Manufactunng Practice Guide for Validation of
Automated Systems in Pharmaceutical Manufacture
(10)Fisher. T., Lyophiltzer Qualification: Some Practical Advice. Drugs and Pharmaceutical
Sciences. Vol. 137, Freeze-Drying/Lyophilization of Pharmaceutical and Biological
Products. 2"° edition. 2004. pp. 517—533. Marcel Dekker
(11)PDA. Process Simulation Testing for Aseptically Filled Products. PDA Technical Report
No. 22. 1996
(12)Jennings, T.A.. Validation of the Lyophllization Process. Validation of Aseptic
Pharmaceutical Processes. 1986, pp. 595—633. Marcel Dekker
(13)Cameron. P „ Good Pharmaceutical Freeze-Drying Practice, 1999, Chapter 9. Interpharm
Press. Denver. CO
(14)Jennings, T.A.. Lyophikzation — Introduction and Basic Principles, 1999. Chapter 8,
Interpharm Press. Denver. CO
(15)Auterhoff. G.. EG-Leltfaden elner Geten Herstellungspraxis fur Arzneimittel. S” edition.
1998. ECV-Verlag, Aulendorf
(16)Oetjen. G.-W.. Gefnertrocknen, 1997. VCH VerlagsgeseUschaft. Welnheim
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