Out of specification results - How to deal with deviations from specifications/backgrounds of the Barr decision/approaches to correct and scientifically well-grounded decisions;Hintergrunde zum Barr-Urteil/losungswege fur eine korrekte und wissenschaftich fundierte entscheidung

Pharmazeutische Industrie

Volumn 60, Issue 11, 1998, Pages 996-1001

  Schmidt, Rainer ^a  

^a ROCHE INNOVATION CENTER MUNICH   (Germany)

Author keywords

Barr Urteil; Normabweichungen; Out of Specification (OOS) results

Indexed keywords

ARTICLE; COURT; DRUG QUALITY; FOOD AND DRUG ADMINISTRATION; GERMANY; LEGAL ASPECT; QUALITY CONTROL;

EID: 0031743192     PISSN: 0031711X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (1)

1. United States of America vs. Barr Laboratories, Inc; Civil Action No. 92-1744, United States District Court for the District of New Jersey - Gold Sheet Vol. 27, No. 2, February, 1993 -Guide to Inspection of Pharmaceutical Quality Control Laboratories, July, 1993