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- Title
Some (abbreviated) facts about GMP compliance.
- Authors
Czap, Al
- Abstract
The article offers information on the good manufacturing practices (GMP) being implemented by the U.S. Food and Drug Administration (FDA). Approaching the third year of GMP implementation, records of inspection of FDA Form 483 showed that FDA focused on GMP violations including product storage and sanitation issues although no manufacturers have been issued warning letters. Areas where the FDA pays specific attention include the identification of raw materials, standard operating procedure (SOP) to ensure product quality and training of personnel.
- Subjects
UNITED States; CURRENT good manufacturing practices; UNITED States. Food &; Drug Administration; FORMS (Law); STORAGE
- Publication
Alternative Medicine Review, 2010, Vol 15, Issue 1, p1
- ISSN
1089-5159
- Publication type
Article