RT Journal Article
SR Electronic
T1 Assessing Risks of Changing Sterile Drug Manufacturing Sites
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 3
OP 10
VO 64
IS 1
A1 Stephen E. Langille
A1 Cliff Campbell
YR 2010
UL http://journal.pda.org/content/64/1/3.abstract
AB This article summarizes a recently completed research assignment conducted on behalf of the Food and Drug Administration's (FDA) Office of Pharmaceutical Science. The assignment addressed the issue of changing sterile drug manufacturing sites from the point of view of both synthetic and biotech drug products. The article is intended to provide readers with an overview of the assignment and to summarize a recommended approach whereby the use of a comparability protocol can satisfy the FDA's review expectations on the one hand, and facilitate streamlined compliance and faster product to market by manufacturers on the other.© PDA, Inc. 2010