Microbiological control of raw materials

Microbial Quality Assurance in Pharmaceuticals, Cosmetics, and Toiletries

Volumn , Issue , 2017, Pages 31-47

  Russell, M ^a  

^a Division of Centocor BV   (Netherlands)

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[No Author keywords available]

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EID: 85128130046     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (23)

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2. Anon. (1980a) Guide to data analysis and quality control using cusum charting, British Standard BS. 5703. British Standards Institution, London.
3. Anon. (1980b) Directive No. 80/778/EEC of 15.7.80 relating to the quality of water intended for human consumption. Off. J. Eur. Communities No. 2229, 11.
4. Anon. (1982) The bacteriological examination of drinking water supplies, Reports on Public Health and Medical Subjects No. 71. HMSO, London.
5. Anon. (1983) European Pharmacopoeia, 2nd edn. Maisonneuve SA, Sainte-Ruffine, France, V.2.1.8-V.2.1.8.10.
6. Anon. (1988) Note for Guidance on the Application of Part 1 of Annex to Directive 75/318/EEC, as amended. In: Rules governing medicinal products in the EEC, Vol. III.
7. Anon. (1989) The rules governing medicinal products in the European Community, Vol. IV. Guide to good manufacturing practice for medicinal products. HMSO, London.
8. Anon. (1990) CT Ρ A limits and guidelines for microbiological quality management. Cosmetic, Toiletry and Perfumery Association, London.
9. Anon. (1993a) British Pharmacopoeia. HMSO, London.
10. Anon. (1993b) Microbial aspects of pharmaceutical water. Pharmaceutical Forum 1993, 19(5) 6183-6187.
11. Anon. (1995a) European Pharmacopoeia, 2nd edn. Maisonneuve SA, Sainte-Ruffine, France, VIII 15.1-15.2
12. Anon. (1995b) United States Pharmacopoeia XXIII. US Pharmacopoeial Convention, Rockville, MD.
13. Cowan, S. T. (1993). Cowan and Steel's manual for the identification of medical bacteria. 3rd edn, Cambridge University Press, Cambridge.
14. Cruikshank, R. (1965) Medical microbiology. 11th edn. Livingstone, London, pp. 964-965.
15. Gallantree, I. (1994) Designing a pharmaceutical process water system. Pharmaceutical Manufacturing International. International Review of Pharmaceutical Technology, Research and Development, pp. 153-157.
16. Hitokoto, H. Morozumi, S., Wauke, T., Sakai, S., and Kuráta, H. (1978) Fungal contamination and mycotoxin detection of powdered herbal drugs. Appl. Environ. Microbiol. 36 252-256.
17. Meles, A. A., Misra, S. S., and Irwin, j. O. (1938) The examination of the bactericidal power of blood. J. Hyg. (Camb) 38 732-749.
18. Payne, D. (1990) Microbial ecology of the production process. In: Denyer, S., and Baird, R. (eds) Guide to microbiological control in pharmaceutics. Ellis Horwood, Chichester, pp. 53-67.
19. Payne, D. (1993) Report of a Joint Pharmaceutical Analysis Group Meeting. Pharmaceutical Journal, 251 30-31.
20. Russell, A. D., Ahonkai, E., and Rogers, D. (1979) Microbiological applications of the inactivation of antibiotics and other antimicrobial agents. J. Appl. Bacteriol. 46 207-245.
21. Russell, M. P., Purdue, R., Goldsmith, J., and Phillips, I. (1984) Computer assisted evaluation of microbiological environmental control data. J. Parenter. Sci. Technol. 38 98-103.
22. Słliker, J. H. (1980a) Microbial ecology of foods, Vol. 1, Factors affecting life and death of micro-organisms. 2nd edn, International Commission on Microbiological Specifications for Foods, Academic Press, London.
23. Słliker, J. H. (1980b) Microbial ecology of foods, Vol. 2, Sampling food commodities, 2nd end, International Commission on Microbiological Specifications for Foods, Academic Press, London.