The FDA approves remibrutinib for symptomatic dermographism, the first such therapy, extending an oral BTK inhibitor label via the Phase III RemIND trial.
News|Articles|May 15, 2019
- Pharmaceutical Technology-05-15-2019
- Volume 2019 eBook
- Issue 1
Distinguishing Between Cleanroom Classification and Monitoring
A one-size-fits-all approach to monitoring practices and results is never appropriate, given the diversity of practice within the pharmaceutical industry.
Advertisement
Cleanroom monitoring and classification are vital to operations but are still separate functions. This article discusses the differences between the two concepts and emphasizes the need for the two to remain independent. As they write, “A one-size-fits-all approach to cleanroom monitoring will not reflect the diversity of practices” within the industry. In addition, they write, classification values should not be used as monitoring targets.
Article Details
Pharmaceutical Technology
eBook: Biologics and Sterile Drug Manufacturing 2019
May 2019
Pages: 10–13
Citation
When referring to this article, please cite it as J. Agalloco, R. Madsen, and J. Akers, “Distinguishing Between Cleanroom Classification and Monitoring," Pharmaceutical Technology Biologics and Sterile Drug Manufacturing eBook (May 2019).
Articles in this issue
over 7 years ago
Supply Chain Challenges for Single-Use Systemsover 7 years ago
Challenges with Successful Commercialization of Biosimilarsover 7 years ago
Test Methods and Quality Control for Prefilled Syringesover 7 years ago
Unknown and UnknowableAdvertisement
Related to this article
The company is showcasing new development solutions and advanced digital technologies including its new OSD Express and Steriles Express solutions for drug development.
Ron Scarboro, Azurity Pharmaceuticals, explains when formulation robustness justifies added cost and which post-approval quality and supply metrics teams can track.
The winners of the CPHI Pharma Awards 2026 include a neurodegeneration platform, a track-and-trace packaging innovation, a enzymatic mRNA manufacturing technology, and a cell-free enzymatic biomanufacturing platform.
Richard Jaenisch explains why NAMs are compressing drug development faster than AI and what FDA's new nonclinical testing rule means for sponsors.
Shadow AI and vendor data retention put GMP records and trade secrets at risk. AI Pulse Check panelists outline what pharma AI policies require.
Hovione's $35M CDC Flex line links spray drying to tablets, designed to eliminate scale-up under FDA Q13 guidance.
This week on PharmTech, Merck diversified its pipeline, USP emphasizes supply chain security, AI systems are examined, and speakers preview their presentations at CPHI Milan and AAPS PharmSci 360.
Advertisement
Advertisement