RT Journal Article
SR Electronic
T1 Points to Consider: Best Practices to Identify Particle Entry Routes along the Manufacturing Process for Parenteral Formulations
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 635
OP 647
DO 10.5731/pdajpst.2019.010645
VO 73
IS 6
A1 Anger, Sylvia
A1 Begat, Cecile
A1 Crnko, Vincent
A1 Fantozzi, GianMaurizio
A1 Farach, Wadi
A1 Fitzpatrick, Sean
A1 Gallagher, Brian
A1 Huelsmann, Stefan
A1 Kinsey, Paul
A1 Langlade, Vincent
A1 Lefevre, Ghislain
A1 Legendre, Elise
A1 McLean, Kevin
A1 Miller, Jahanvi
A1 Patel, Ravi
A1 Perry, Anthony
A1 Soukiassian, Herve
A1 Stanton, Amy
A1 Streich, Dorothee
A1 Timmons, Christopher
A1 Vaneylen, DAVID
A1 van Hoose, Tony
A1 Wildling, Linda
A1 Windover, Mike
YR 2019
UL http://journal.pda.org/content/73/6/635.abstract
AB During the processes involved in pharmaceutical manufacturing, particulate matter may be introduced into a product from a variety of sources and at different points in the manufacturing process. Companies design quality at the beginning of the process to ensure against defects and strive to manufacture products that meet the pharmacopeial standard of being “practically/essentially free” of particles, which can be challenging, though necessary. As particulate matter recalls are predominantly associated with parenteral products, most companies employ a quality risk management program to identify critical parameters or conditions that could affect product quality or patient safety and incorporate systemic and procedural controls to mitigate or reduce the probability of their occurrence. Yet, determining where particulates are most likely to enter the process, what types of materials are most vulnerable, and how the size and number of particles might affect product quality can be very complex. Visual inspection and sampling of the manufactured drug product are designed to control the risk of particulate contamination; building prevention controls will ensure sustainability. This concept paper highlights the necessity of a more thorough understanding of the failure mechanisms that result in particle contamination across a range of products, such as elastomeric components and glass, and processes, such as the formulation and filling of injectables. The goal is to identify process steps within the end-to-end manufacturing process that are most critical to particle generation and entering of visible particles into the final drug product.LAY ABSTRACT: This concept paper highlights the necessity of a more thorough understanding of the failure mechanisms that result in particle contamination across a range of products, such as elastomeric components and glass, and processes, such as the formulation and filling of injectables. The goal is to identify process steps within the end-to-end manufacturing process that are most critical to particle generation and entering of visible particles into the final drug product.