The four steps of PAT implementation

Pharmaceutical Engineering

Volumn 25, Issue 1, 2005, Pages 10-22

  Davis, John R ^b   Wasynczuk, John ^a  

^a Lloyd's Register Capstone Inc   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTIC METHOD; CONTROL SYSTEM; DATA ANALYSIS; DRUG INDUSTRY; DRUG MANUFACTURE; FOOD AND DRUG ADMINISTRATION; MEASUREMENT; PHARMACEUTICAL ENGINEERING; PHILOSOPHY; PROCESS ANALYTICAL TECHNOLOGY; PROCESS DESIGN; PROCESS MONITORING; PROCESS TECHNOLOGY; QUALITY CONTROL; REVIEW; RISK ASSESSMENT; STATISTICAL MODEL; TECHNOLOGY; TRAINING;

EID: 14844335964     PISSN: 02738139     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (4)

1. st Century: A Risk-Based Approach," http.//www.fda.gov/cder/gmp/ index.htm.
2. FDA, "Guidance for Industry: PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance."
3. George, Michael L., Lean Six Sigma, New York, NY: The McGraw-Hill Companies, Inc., 2002, pp 33-60.
4. nd ed., Hoboken, NJ: John Wiley & Sons, Inc., 2003, pp 111-140.