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 Sylvia Anger
A1 Cecile Begat
A1 Vincent Crnko
A1 GianMaurizio Fantozzi
A1 Wadi Farach
A1 Sean Fitzpatrick
A1 Brian Gallagher
A1 Stefan Huelsmann
A1 Paul Kinsey
A1 Vincent Langlade
A1 Ghislain Lefevre
A1 Elise Legendre
A1 Kevin McLean
A1 Jahanvi Miller
A1 Ravi Patel
A1 Anthony Perry
A1 Herve Soukiassian
A1 Amy Stanton
A1 Dorothee Streich
A1 Christopher Timmons
A1 DAVID Vaneylen
A1 Tony van Hoose
A1 Linda Wildling
A1 Mike Windover
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.