Preventing the practice of testing into compliance: A practical solutions guide

Pharmaceutical Technology North America

Volumn 26, Issue 10, 2002, Pages 138-146

  Torbeck, Lynn D ^a  

^a Torbeck and Assoc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

REGULATORY COMPLIANCE; TESTING;

PRACTICAL SOLUTIONS GUIDE;

DRUG PRODUCTS PLANTS;

CALCULATION; COMPETENCE; DOCUMENTATION; DRUG SCREENING; FOOD AND DRUG ADMINISTRATION; GOOD MANUFACTURING PRACTICE; LABORATORY TEST; QUALITY CONTROL; REVIEW; TRAINING; VALIDATION PROCESS;

EID: 0036794688     PISSN: 15342131     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (2)

1. CDER, "Investigating Out of Specification (OOS) Test Result* for Pharmaceutical Production," September (1998).
2. L.D. Torbeck, "Reportable Values for Out-of-Specification Test Results," Pharm. Technol. (Analytical Validation supplement, February 1999), p. 21.