Validation of critical process input parameters in the production of protein pharmaceutical products: A strategy for validating new processes or revalidating existing processes

PDA Journal of Pharmaceutical Science and Technology

Volumn 54, Issue 4, 2000, Pages 315-319

  Martin Moe, S ^a   Ellis, J ^a   Coan, M ^a   Victor, R ^a   Savage, J ^a   Bogren, N ^a   Leng, B ^a   Lee, C ^a   Burnett, M ^a   Montgomery, P ^a  

^a NONE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; DRUG DETERMINATION; DRUG RESEARCH; DRUG SYNTHESIS; QUALITY CONTROL; VALIDATION PROCESS;

PROTEINS; TECHNOLOGY, PHARMACEUTICAL;

EID: 0033840058     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (3)

1. Defining critical variables in well-characterized biotechnology processes