This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
|Articles|May 15, 2014
- Pharmaceutical Technology-05-15-2014
- Volume 2014 eBook
- Issue 2
Achieving and Maintaining Compliance Using Continuous Monitoring Systems
Author(s)Asbjørn Jensen
Challenges encountered when implementing a continuous monitoring system are reviewed.
Advertisement
There are a number of challenges when implementing a continuous monitoring system.
The author presents issues encountered at Novo Nordisk and discusses how expanding the scope of monitoring, together with frequent and thorough review of data, can help keep a facility in compliance.
Download
.
Articles in this issue
over 12 years ago
Potential Benefits Drive Interest in Continuous Manufacturingover 12 years ago
Continuous Bioprocessing Challengesover 12 years ago
Optimizing the Sterilization of Liquids in Sealed Containersover 12 years ago
Using Modular Systems in Biopharmaceutical Manufacturingover 12 years ago
Determining Protein Oxidation Induced During Fill-Finish Operationsover 12 years ago
Single-Use Technology in Parenteral Fill/FinishAdvertisement
Related to this article
Andrea K. Kerrigan, FDA, outlines how validation, data integrity, and QRM determine whether digital tools and AI strengthen or undermine CGMP compliance.
PDA/FDA 2026 session maps the GMP audit lifecycle, root cause to CAPA closure, plus a local vs. above-site decision framework and two case studies.
The recently opened NJ spray drying facility doubles capacity for amorphous solid dispersions, addressing solubility limits in roughly 70% of small-molecule pipelines.
Lori Dingledine, QC Director Microbiological Control and GTIC Operations at Genentech, provided input on the regulations surrounding raw material manufacturing and use for ATMPs in a presentation at the 2026 PDA/FDA Joint Regulatory Conference.
AI can turn medical device risk management into a continuous signal.
Sanofi will transfer 20 mature medicines and three manufacturing sites to Cheplapharm for a 26.4% equity stake, closing by Q3 2027.
On PharmTech.com this week, coverage of upcoming events continued, experts continued to discuss the use of AI in pharma, and validation in oral solid dosage product production was emphasized.
Advertisement
Advertisement