Referências: |
BRASIL, Ministério da Saúde, ANVISA, Resolução n. 210, agosto de 2003. DOU, 14/08/2003. REGULAMENTO TÉCNICO DAS BOAS PRÁTICAS
DE FABRICAÇÃO DE MEDICAMENTOS.
BRASIL, Ministério da Saúde, ANVISA, Resolução n. 249, setembro de 2005. DOU, 26/09/2005. REGULAMENTO TÉCNICO DAS BOAS PRÁTICAS
DE FABRICAÇÃO DE PRODUTOS INTERMEDIÁRIOS E INSUMOS FARMACÊUTICOS ATIVOSCOBO, F. and CONCHA, A. Environmental microbial contamination in a stem cell bank Letters in Applied Microbiology 44 (2007) 379?386
CROWLEY, R.; FITZGERALD, L.H.; The impact of cGMP compliance on consumer confidence in dietary supplement products Toxicology 221 (2006)
9?16
FAZIO, T.T.; SINGH, A.K.; KEDOR-HACKMANN, E.R.M.; SANTORO, M.I.R.M. Quantitative determination and sampling of azathioprine residues for
cleaning validation in production area. Journal of Pharmaceutical and Biomedical Analysis 43 (2007) 1495?1498
LAUGEN, B.T.; ACUR, N.; BOER, H.; FRICK, J. Best manufacturing practices. What do the best-performing companies do? International Journal of
Operations & Production Management. 25 (2), 2005, 131-150
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics
Evaluation and Research, Office of Regulatory Affairs. Pharmaceutical CGMPs Guidance for Industry Sterile Drug Products Produced by Aseptic
Processing ? Current Good Manufacturing Practice, august 2003.
Food and Drug Administration, Center for Drugs and Biologics and Center for Devices and Radiological Health. GUIDELINE ON GENERAL
PRINCIPLES OF PROCESS VALIDATION, may 1987 |