Search results for " regulators"
Article
Avoiding Investigational Failures and Discrepancies
Avoiding Investigational Failures and Discrepancies
Investigational failures and discrepancies can be avoided through the proper execution and documentation of investigations.
By Walt Murray,…
Article
Best Practices for Data Integrity
Best Practices for Data Integrity
Optimize practices and meet requirements using electronic data integrity systems.
By Jennifer Markarian
Maintainin…
Article
Managing Residual Impurities During Downstream Processing
He adds that the use of commercial or platform assays early in development is common, but most regulators expect a well-qualified process-specific or platform assay for later development and post-appr…
Article
Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
By Catherine Shaffer
Four biosimilars have been approved for the market by FDA as of February 2017, and more are in the pipeline. Now that biosimilars are here to stay, manufacturers are devel…
Article
Automating Processes in Upstream Processing
…d with process control systems, and the collection and the protection of these data is paramount for regulators. Proving data integrity is one of the most important aspects of any control system as t…
Article
Advancing Single-Use Technology Through Collaboration
“We still need more three-way conversations between end users, suppliers, and regulators, so that we are all on the same page on the key challenges and mutual expectations, as well as the regulatory i…
Article
Efforts Accelerate to Streamline Postapproval Change Process
FDA and other regulators have sought to address these issues by encouraging industry adoption of continual improvement and quality-by-design approaches, along with change management protocols and life…
Article
What’s In a Name? For Biosimilars, A Lot
Jun 01, 2015
By Randi Hernandez
BioPharm International
Volume 28, Issue 6
There is still some uncertainty surrounding whether a biosimilar will share the same compendial identity—or …
Article
Modern Manufacturing Systems Key to FDA Quality Initiative
Apr 02, 2015
By Jill Wechsler
Pharmaceutical Technology
Volume 39, Issue 4
To ensure patient access to high quality, safe, and effective medicines, FDA spends considerable time and resou…
Article
The Bullish Outlook for Biosimilars
Feb 01, 2015
By Jill E. Sackman, PhD, Michael J. Kuchenreuther, PhD
BioPharm International
There are several important reasons for stakeholders to be optimistic about prospects for b…