@article {Goebel348, author = {Paul W. Goebel}, title = {Application of Good Manufacturing Practice Regulations To Investigational Biologic Products}, volume = {34}, number = {5}, pages = {348--351}, year = {1980}, publisher = {Parenteral Drug Association (PDA)}, abstract = {A discussion of the Food and Drug Administration{\textquoteright}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.}, issn = {0006-3363}, URL = {https://journal.pda.org/content/34/5/348}, eprint = {https://journal.pda.org/content/34/5/348.full.pdf}, journal = {PDA Journal of Pharmaceutical Science and Technology} }