Role of quality control in validation of biopharmaceutical processes: case example of clean-in-place (CIP) procedure for a bioreactor.
PDA J Pharm Sci Technol
; 48(5): 236-40, 1994.
Article
em En
| MEDLINE
| ID: mdl-8000897
ABSTRACT
If ever clear instruction and close teamwork is needed, it is in the validation of manufacturing processes. All members of the Validation Team need to understand how the Quality Control testing fits into the overall validation work plan. This affords the team members the opportunity to understand how data will be used and avoids a situation where the test results either invalidate or inadequately support the validation plan. A case example is presented for an approach used to validate Clean-in-Place (CIP) procedures for 1600 L bioreactors which are operated on a campaign basis for multi-biopharmaceutical synthesis.
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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Controle de Qualidade
/
Proteínas Recombinantes
/
Contaminação de Medicamentos
/
Indústria Farmacêutica
Tipo de estudo:
Diagnostic_studies
País/Região como assunto:
America do norte
Idioma:
En
Revista:
PDA J Pharm Sci Technol
Assunto da revista:
FARMACIA
/
FARMACOLOGIA
Ano de publicação:
1994
Tipo de documento:
Article