A PAT solution for water testing

Innovations in Pharmaceutical Technology

Volumn , Issue 23, 2007, Pages 112-118

  Janke, Donovan Maribeth ^a  

^a Lonza Walkersville

Author keywords

[No Author keywords available]

Indexed keywords

DRUG; ENDOTOXIN; REAGENT; RECOMBINANT FACTOR C; UNCLASSIFIED DRUG;

ARTICLE; ASSAY; COMPUTER SYSTEM; CONTAINER; DRUG MANUFACTURE; DRUG QUALITY; ENDOTOXIN DETECTION; GOOD MANUFACTURING PRACTICE; LIMULUS LYSATE TEST; ONLINE ANALYSIS; PROCESS CONTROL; PROCESS OPTIMIZATION; PROCESS TECHNOLOGY; PURIFICATION; QUALITY CONTROL; ROBOTICS; TOXIN ANALYSIS; WATER ANALYSIS; WATER QUALITY; WATER SAMPLING;

EID: 38949121060     PISSN: 14717204     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Article

References (4)

1. US Department of Health and Human Services, Food and Drug Administration, Guidance for Industry, PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. Pharmaceutical CGMPs. September 2004.
2. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human use, Final Concept Paper, Q10: Pharmaceutical Quality Systems. September 2005.
3. L. Chen. Reckoning Recombinant Factor C. Pharmaceutical Formulation and Quality. December/January, 58-60, 2006.
4. US Pharmacopeia. USP30-NF25. 2007.