Search results for " regulations"
Article
Avoiding Investigational Failures and Discrepancies
By Walt Murray, James Jardine
Investigations-focused regulatory standards that apply to life-sciences organizations, such as FDA 21Code of Federal Regulations (CFR) 211.192, mand…
Article
Best Practices for Data Integrity
If manufacturing data are missing or inaccurate, then the firm is in violation of GMP regulations; it may mean that the quality of the product cannot be trusted. In serious cases, bad data integrity c…
Article
Managing Residual Impurities During Downstream Processing
“Consequently,” Wake observes, “as the regulations surrounding impurities and product specification continue to evolve, manufacturers will be presented with challenges not only with respect to the man…
Article
Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
It can be difficult to change or improve processes with the strict regulations around biologics and biosimilars. “We’re working with several biosimilar companies and also working with innovators,” Elh…
Article
Automating Processes in Upstream Processing
Biopharma companies are focused on 21 Code of Federal Regulations Part 11 assessments to document which aspects of the regulation are covered by the control system and which aspects may be covered via…
Article
Advancing Single-Use Technology Through Collaboration
By working together to harmonize the highly variable steps within the biopharmaceutical manufacturing process, both end users and suppliers are making strides toward the efficiency and integrity of …
Article
Efforts Accelerate to Streamline Postapproval Change Process
But those few significant changes that have to be reported to authorities according to different local regulations can take years to process, particularly for biotechnology-derived products that are m…
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
FDA is still developing its final regulations and guidelines pertaining to biosimilar approval in the US. While not formalized yet, preliminary guidance suggests that this pathway will require the com…