Ronald Piervincenzi, USP, urges drugmakers and purchasers to act on supply chain resilience to curb drug shortages and shape better policy.
|Articles|May 2, 2016
- Pharmaceutical Technology-05-02-2016
- Volume 40
- Issue 5
Penetrometer for Quality Monitoring
The penetrometer PNR 12 from Anton Paar, used for quality monitoring, features the Pharma Qualification Package--Smart PNR 12, which fulfills GMP and United States Pharmacopeia (USP) regulations and can be used to perform qualification processes.
The penetrometer PNR 12 from Anton Paar, used for quality monitoring, features the Pharma Qualification Package--Smart PNR 12, which fulfills GMP and United States Pharmacopeia (USP) <1058> regulations and can be used to perform qualification processes. PNR 12 can complete cone and needle tests for petrolatum, ointments, and wax. The penetrometer requires a sample size of 4 mL, which results in short temperature-stabilization intervals. Tests can also be performed outside an analytical laboratory, and 16 different programs are available to run on the penetrometer independently.
Articles in this issue
over 10 years ago
Forced Degradation Studies for Biopharmaceuticalsover 10 years ago
Choosing Containment Strategies For Highly Potent APIsover 10 years ago
Visions for the Future of Biopharma Manufacturingover 10 years ago
Outsourcing of Biomanufacturing in 2016over 10 years ago
Pharmaceutical Quality: Where Do We Need to Go from Here?over 10 years ago
Reporting Quality Metrics to FDAover 10 years ago
Significant Revisions and Updates to the European Pharmacopoeiaover 10 years ago
The Value of Saving LivesRelated to this article
Content on PharmTech.com this week ranged from fundamentals on the use of digital pathology in drug development, discussions on the use of AI in pharma, and regulatory actions impacting the industry.
This article discusses risk-based lifecycle governance, system implementation considerations, and the progression of batch record control from paper-based to fully electronic systems.
Ronald Piervincenzi, USP, explains why manufacturers should act now and how benchmarking could reward reliable generic drug suppliers.
The FDA approves Lilly's once-weekly insulin efsitora for type 2 diabetes, raising Fc-fusion manufacturing, high-concentration pen, and capacity questions.
Florin Muraru, Gourav Pandey, and Richard Jaenisch explain where human sign-off belongs as multi-agent AI and document-parsing models reach GxP.
In this episode of Ask the Expert, Siegfried Schmitt, PhD, vice president, Technical at Parexel, and Susan J. Schniepp, distinguished fellow at Nelson Labs, discuss how companies should approach post-approval changes to their CMC regulatory filings.
The EC has approved AstraZeneca's Trixeo Aerosphere as the first single-inhaler triple-combination therapy for asthma in the EU, based on phase e data showing improved lung function and fewer severe exacerbations in patients uncontrolled on standard ICS/LABA treatment.
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