RT Journal Article
SR Electronic
T1 Achieving “Zero” Defects for Visible Particles in Injectables
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 640
OP 650
DO 10.5731/pdajpst.2018.009027
VO 72
IS 6
A1 Johns, Jennifer
A1 Golfetto, Paolo
A1 Bush, Tia
A1 Fantozzi, Gianmaurizio
A1 Shabushnig, John
A1 Perry, Anthony
A1 Degrazio, Fran
A1 Streich, Dorothee
A1 Miller, Jahanvi
A1 Soukiassian, Herve
A1 Stanton, Amy
A1 Watson, Rick
YR 2018
UL http://journal.pda.org/content/72/6/640.abstract
AB The reduction of visible particles in injectable products is an important element in the consistent delivery of high-quality parenteral products. An important part of this effort is the control of particles that may emanate from the primary packaging materials. The Parenteral Drug Association (PDA), with the support of the Pharmaceutical Manufacturers Forum (PMF), has undertaken the task of developing test methods to assess the cleanliness of primary packaging components used in the manufacturing of sterile injectable products. Further work is focused on end-to-end analysis of the supply chain to identify additional points where particles may enter the finished product workflow. This includes shipment, receipt, transfer, and fill and finishing operations. This information and appropriate corrective actions and control methods, coupled with appropriate patient risk-based acceptance limits, are intended to provide better and more consistent supply of injectable products that meet current compendial and good manufacturing practice (GMP) expectations. Aligning control limits between supplier and pharmaceutical manufacturers will offer further improvement. This paper describes the formation of a task force to address these needs and current progress to date.LAY ABSTRACT: Visible particles must be controlled in parenteral products. Such particles come from many sources including the primary packaging materials. The Parenteral Drug Association (PDA), with the support of the Pharmaceutical Manufacturers Forum (PMF), has formed a task force to review and improve particle measurement methods and perform an end-to-end analysis of how particles may enter into parenteral products. These activities are intended to lead to more consistent control limits for visible particles and ultimately more consistent supply of high quality injectable products.