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Pregled bibliografske jedinice broj: 321685

Radiation decontamination of pharmaceutical raw materials as an integral part of the good pharmaceutical manufacturing practice (GPMP)

Ražem, Dušan; Katušin-Ražem, Branka; Starčević, M.; Galeković, B.
Radiation decontamination of pharmaceutical raw materials as an integral part of the good pharmaceutical manufacturing practice (GPMP) // International journal of radiation applications and instrumentation. Part C, Radiation physics and chemistry, 35 (1990), 1-3; 377-381 doi:10.1016/1359-0197(90)90123-Y (međunarodna recenzija, članak, znanstveni)

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Naslov
Radiation decontamination of pharmaceutical raw materials as an integral part of the good pharmaceutical manufacturing practice (GPMP)

Autori
Ražem, Dušan ; Katušin-Ražem, Branka ; Starčević, M. ; Galeković, B.

Izvornik
International journal of radiation applications and instrumentation. Part C, Radiation physics and chemistry (1359-0197) 35 (1990), 1-3; 377-381

Vrsta, podvrsta i kategorija rada
Radovi u časopisima, članak, znanstveni

Ključne riječi
GPMP ; irradiation ; quality assurance ; pharmaceuticals ; starch

Sažetak
The microbiological quality of many raw materials used in the manufacture of pharmaceuticals and adjuvants often fails to meet the standards set by the pharmaceutical industry. Raw materials of biological provenience are particularly susceptible to contamination. This work describes the present situation regarding the microbial load of corn starch. Given the accepted microbiological criteria, irradiation treatment is proposed as integral to Good Pharmaceutical Manufacturing Practice (GPMP). The use of total viable count as a guide for specifying microbial limites for non-sterile materials is supported. Criteria for the choice of dose are discussed.

Izvorni jezik
Engleski

Znanstvena područja
Kemija



POVEZANOST RADA

Ustanove:
Pliva-Istraživački institut,
Institut "Ruđer Bošković", Zagreb

Profili:

Avatar Url Branka Katušin-Ražem (autor)

Avatar Url Dušan Ražem (autor)

Poveznice na cjeloviti tekst rada:

doi www.sciencedirect.com

Citiraj ovu publikaciju:

Ražem, Dušan; Katušin-Ražem, Branka; Starčević, M.; Galeković, B.
Radiation decontamination of pharmaceutical raw materials as an integral part of the good pharmaceutical manufacturing practice (GPMP) // International journal of radiation applications and instrumentation. Part C, Radiation physics and chemistry, 35 (1990), 1-3; 377-381 doi:10.1016/1359-0197(90)90123-Y (međunarodna recenzija, članak, znanstveni)
Ražem, D., Katušin-Ražem, B., Starčević, M. & Galeković, B. (1990) Radiation decontamination of pharmaceutical raw materials as an integral part of the good pharmaceutical manufacturing practice (GPMP). International journal of radiation applications and instrumentation. Part C, Radiation physics and chemistry, 35 (1-3), 377-381 doi:10.1016/1359-0197(90)90123-Y.
@article{article, author = {Ra\v{z}em, Du\v{s}an and Katu\v{s}in-Ra\v{z}em, Branka and Star\v{c}evi\'{c}, M. and Galekovi\'{c}, B.}, year = {1990}, pages = {377-381}, DOI = {10.1016/1359-0197(90)90123-Y}, keywords = {GPMP, irradiation, quality assurance, pharmaceuticals, starch}, journal = {International journal of radiation applications and instrumentation. Part C, Radiation physics and chemistry}, doi = {10.1016/1359-0197(90)90123-Y}, volume = {35}, number = {1-3}, issn = {1359-0197}, title = {Radiation decontamination of pharmaceutical raw materials as an integral part of the good pharmaceutical manufacturing practice (GPMP)}, keyword = {GPMP, irradiation, quality assurance, pharmaceuticals, starch} }
@article{article, author = {Ra\v{z}em, Du\v{s}an and Katu\v{s}in-Ra\v{z}em, Branka and Star\v{c}evi\'{c}, M. and Galekovi\'{c}, B.}, year = {1990}, pages = {377-381}, DOI = {10.1016/1359-0197(90)90123-Y}, keywords = {GPMP, irradiation, quality assurance, pharmaceuticals, starch}, journal = {International journal of radiation applications and instrumentation. Part C, Radiation physics and chemistry}, doi = {10.1016/1359-0197(90)90123-Y}, volume = {35}, number = {1-3}, issn = {1359-0197}, title = {Radiation decontamination of pharmaceutical raw materials as an integral part of the good pharmaceutical manufacturing practice (GPMP)}, keyword = {GPMP, irradiation, quality assurance, pharmaceuticals, starch} }

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