PT  - JOURNAL ARTICLE
AU  - Goebel, Paul W.
TI  - Application of Good Manufacturing Practice Regulations To Investigational Biologic Products
DP  - 1980 Sep 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 348--351
VI  - 34
IP  - 5
4099  - http://journal.pda.org/content/34/5/348.short
4100  - http://journal.pda.org/content/34/5/348.full
SO  - PDA J Pharm Sci Technol1980 Sep 01; 34
AB  - A discussion of the Food and Drug Administration’s authority to regulate investigational biologic products; the changes that were necessary with the inclusion of biologies under Part 211, Good Manufacturing Practice regulations, and procedures currently in effect to assure integrity of the test article and compliance with Good Manufacturing Practices.