The end of process validation: As we know it?

Pharmaceutical Technology

Volumn 29, Issue 8, 2005, Pages 36-42

  Bush, Laura ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

CHEMICAL INDUSTRY; DRUG PRODUCTS; FOOD PRODUCTS; SOCIETIES AND INSTITUTIONS;

FDA; PROCESS VALIDATION;

DRUG PRODUCTS PLANTS;

BEVACIZUMAB; MONOCLONAL ANTIBODY;

COLON CANCER; DRUG COST; DRUG MANUFACTURE; DRUG QUALITY; FOOD AND DRUG ADMINISTRATION; METASTASIS; NEAR INFRARED SPECTROSCOPY; PROCESS DEVELOPMENT; PROCESS MODEL; QUALITY CONTROL; RAMAN SPECTROMETRY; RECTUM CANCER; REVIEW;

EID: 23744451157     PISSN: 15432521     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (4)

1. US Food and Drug Administration, Guideline on General Principles of Process Validation (FDA, Rockville, MD, May 1987).
2. FDA, Guidance for Industry PAT-A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (FDA, Rockville, MD, Sept. 2004).
3. D. McCormick, "PAT Survey Reflects Optimism, Uncertainty," Pharm. Technol. 29 (1), 24 (2005).
4. FDA, Innovation and Continuous Improvement in Pharmaceutical Manufacturing. Pharmaceutical CGMPs for the 21st Century (FDA, Rockville, MD, Sept. 2004), p. 8; available at http://www.fda.gov/cder/gmp/gmp2004/ manufSciWP.pdf.