Search results for " change management"
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
Continuous Manufacturing: A Changing Processing Paradigm
Apr 01, 2015
By Randi Hernandez
BioPharm International
Volume 28, Issue 4
Although continuous manufacturing is well established for bulk chemicals, complex automation and validation …
Article
Climate Change in Outsourcing
As 2013 draws to a close, the bio/pharmaceutical industry continues to be reshaped by changes in the business climate. Financial, political, and scientific developments that began 10 years ago conti…
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The Lifecycle Change of Process Validation and Analytical Testing
In the two years since the publication of FDA's final process validation guidance, how has this new lifecycle approach affected the way the industry performs validation? BioPharm Internati…
Article
Driving Change in Biomanufacturing
Whatever the objective, driving change is a challenge. Implementing a new technology into a bioprocess is a big change. The new technology must be fully understood, all regulatory requirements fulfi…
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Discovering the unknown: How does in silico process development change PD scientists’ work?
In silico process development for chromatography is a paradigm-shifting approach that redefines the routine work of process development scientists. But what does it actually mean to perfor…
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Regulatory Challenges in the QbD Paradigm
Variability of raw materials and change management would be assessed. Current emphasis is on excluding complex biologically derived raw materials whenever possible and/or treating materials for inacti…
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Supplier-Change Management for Drug-Product Manufacturers
Pharmaceutical change management processes extend to the materials and services employed to manufacture and test drug products, necessitating the need for an effective supplier-initiated change (SIC) …
Article
Quality Systems Key to Lifecycle Drug Management
FDA also hopes to revise guidance on providing CMC information in comparability protocols for approved drugs to encourage adoption of innovative test methods and new approaches to change management. …
Article
Supply Chain Challenges for Single-Use Systems
BioPharm: What are some of the challenges with change management?
Carter (Cytiva): Some suppliers produce products for our industry, but their main industry is not ours. It has been observed that …