RT Journal Article
SR Electronic
T1 Rapid Sterility Test Systems in the Pharmaceutical Industry: Applying a Structured Approach to Their Evaluation, Validation and Global Implementation
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 211
OP 235
DO 10.5731/pdajpst.2021.012672
VO 77
IS 3
A1 Deutschmann, Sven
A1 Paul, Mousumi
A1 Claassen-Willemse, Marja
A1 van den Berg, Jonas
A1 IJzerman-Boon, Pieta
A1 Grunert da Fonseca, Viviane
A1 Brunbech, Ellen
A1 Johnson, Lynn
A1 Knutsen, Chris
A1 Plourde, Lucile
A1 Salvas, Joanny
A1 Villari, Philip
A1 Wysocki, Lisa
YR 2023
UL http://journal.pda.org/content/77/3/211.abstract
AB The current compendial sterility test has a 14-day incubation time and is often the time-limiting step in the Assess and Release Process of pharmaceutical products. There is an ever-increasing number of technologies available on the market that have benefits in addition to faster Time to Result, such as standardization and automation of readout (eliminating analyst subjectivity) and improved data integrity (including eliminating the need for contemporaneous verification of the result by another analyst). Regulators have been encouraging the pharmaceutical industry to adopt these innovative systems; however, it has taken a considerable time before receiving the first approvals from various health authorities (including both the European Medicines Agency and Food and Drug Administration) for the use of an alternative and rapid sterility test for the release of sterile drug product lots. This article describes a systematic 9-step approach to the evaluation, equipment qualification, validation, and deployment of alternative sterility tests that can be applied by pharmaceutical companies wanting to take advantage of the numerous benefits of alternative sterility tests. Two case studies are presented to illustrate the validation and implementation approach, including statistical methods. Although most of the steps toward implementation are aligned, the validation and transfer have been approached differently for each of the case studies because of differences in the chosen technology as well as independent company internal decisions to comply with validation guidelines. However, both case studies show successful implementation of an alternative sterility test for sterile drug products with an ∼50% reduced incubation time.