RT Journal Article
SR Electronic
T1 Visible Particulate Contamination Control for Injectable Products: A Lifecycle Approach
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP pdajpst.2019.010462
DO 10.5731/pdajpst.2019.010462
A1 Stephen Langille
YR 2019
UL http://journal.pda.org/content/early/2019/11/15/pdajpst.2019.010462.abstract
AB Visible particulate matter contamination is responsible for the rejection or recall of numerous batches of injectable product each year. The result is wasted time, effort, money, product, and the limited availability of medically necessary drug and biologic products. Recently published compendial standards have alleviated some of the confusion surrounding suitable test methods and acceptance criteria for visible particulates, however the complexities of visual inspection methods across a wide range of injectable product types packaged in diverse and sometimes complex container systems has complicated the approach to visible particulate control in injectable products. The solution is a lifecycle approach to visible particulate contamination control which addresses the prevention, inspection, identification, and remediation of visible particulate contamination. More importantly, the lifecycle approach to visible particulate control is aligned with current FDA CGMPs and can serve as an effective tool for demonstrating regulatory compliance for inspections, audits, and regulatory submissions.