Defining process design space: A risk-management case study (part 1)

Pharmaceutical Technology

Volumn 35, Issue 7, 2011, Pages 77-79

  Frank, Ted ^a   Brooks, Stephen ^b   Murray, Kristin ^b   Reich, Steve ^b   Sanchez, Ed ^c   Hasselbalch, Brian ^d   Obeng, Kwame ^e   Creekmore, Richard ^f  

^a MERCK RESEARCH LABORATORIES   (United States)

^b PFIZER INC   (United States)

^c Johnson and Johnson ^*  (United States)

^d CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^e BRISTOL MYERS SQUIBB   (United States)

^f ASTRAZENECA   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

INTERNATIONAL CONFERENCE ON HARMONIZATIONS; MANUFACTURING TECHNOLOGIES; PHARMACEUTICAL QUALITY; PHARMACEUTICAL TECHNOLOGIES; RESEARCH INSTITUTES; WORKING GROUPS;

INDUSTRIAL RESEARCH; MANUFACTURE; PROCESS DESIGN; RISK MANAGEMENT;

OCCUPATIONAL RISKS;

ARTICLE; CASE STUDY; CHEMICAL ANALYSIS; DOCUMENTATION; DRUG FORMULATION; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG QUALITY; DRUG RELEASE; DRUG SOLUBILITY; EQUIPMENT DESIGN; FAILURE MODE EFFECT ANALYSIS; FOLLOW UP; INTERPERSONAL COMMUNICATION; POLICY; PROBABILITY; PROCESS DESIGN; PRODUCT DEVELOPMENT; QUALITY CONTROL; QUALITY RISK MANAGEMENT; RISK ASSESSMENT; RISK MANAGEMENT; SCORING SYSTEM;

EID: 80051910936     PISSN: 15432521     EISSN: 21507376     Source Type: Journal    
DOI: None     Document Type: Article

References (4)

1. FDA Global Harmonization Task Force, "Implementation of Risk Management Principles andActivities within a Quality Management System" (Rockville, MD, 2000).
2. ICH, Q9 Quality Risk Management, 2005.
3. FDA, Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations (Rockville, MD, 2006).
4. FDA, "Risk-Based Method for Prioritizing CGMP Inspections of Pharmaceutical Manufacturing Sites-A Pilot Risk Ranking Model, " (Rockville, MD, 2004).