Search results for " lifecycle management"
Article
Eliminating Residual Impurities Starts with a Strategic Plan
“A lifecycle management system for the risk assessment of process-related impurities should be in place that includes and evaluates relevant changes in regulatory requirements (e.g., changes in guidel…
Article
Using Quality by Design to Develop Robust Chromatographic Methods
Quality-by-design principles can be used to understand chromatographic measurement system variability.
Sep 2, 2014
By: Melissa Hanna-Brown, Kimber Barnett, Brent Harrington, Tim Graul, Jim…
Article
Establishing Acceptance Criteria for Analytical Methods
Knowing how method performance impacts out-of-specification rates may improve quality risk management and product knowledge.
By Thomas A. Little, PhD
To control the consistency and quality o…
Article
The Affordable Care Act's Impact on Innovation in Biopharma
The biopharmaceutical industry contemplates product innovation within the changing landscape of healthcare.
The Affordable Care Act (ACA) has elicited intense national debate and sent biopharm…
Article
Using Software in Process Validation
Using Software in Process Validation
Software systems can help validate pharmaceutical manufacturing and steer the most appropriate design of processes in the right direction.
…
Article
Addressing the Complex Nature of Downstream Processing with QbD
Quality by design brings both challenges and benefits to the development of downstream processes.
By Susan Haigney
natali_mis/Stock.Adobe.com
Regulators have been en…
Article
Understanding Validation and Technical Transfer, Part I
Understanding Validation and Technical Transfer, Part I
This is the first of a series of three articles about validation and technical transfer in the bio-pharmaceutical industry. Part 1 || Part 2 |…
Article
The New World of Biopharmaceutical Manufacturing
That might imply driving toward standardization from different perspectives: designs, interconnectivity, technical qualification packages, certificates, manufacturing practices, and product lifecycle …
Article
Breakthrough Drugs Raise Development and Production Challenges
The initiative, he noted, requires risk-based assessment strategies and a product quality lifecycle management plan, combined with clear analysis of what can be evaluated during review, and what can b…
Article
Modular Manufacturing Platforms for Biologics
May 01, 2015
By Randi Hernandez
BioPharm International
Volume 28, Issue 5
It should come as no surprise that the good design principles governing the execution of pharmaceutical manu…