Quality Systems

Oct 16, 2018
By BioPharm International Editors
The new guidance, Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings Guidance for Industry, discusses the planning of pre-IND meetings with FDA and sponsors.
Oct 16, 2018
By BioPharm International Editors
The agency is developing technology- and disease-specific regulatory frameworks for innovations that may not have previously had a clear development pathway.
Oct 16, 2018
By BioPharm International Editors
The guidance describes the agency's recommendations on how to group patients with different molecular alterations and approaches for evaluating the benefits and risks of targeted therapies where some molecular alterations may occur at low frequencies.
Oct 15, 2018
BioPharm International
The testing of raw materials is essential as raw material quality determines the outcome of biologic product quality.
Oct 15, 2018
BioPharm International
Providing analytical data on the comparison between a biosimilar and the reference product is a primary consideration in the development of biosimilars.
Oct 10, 2018
Congress approves bills with provisions important to FDA and industry, some of which reflect continuing concerns about drug pricing and transparency.
Oct 01, 2018
BioPharm International
Applied throughout a product’s lifecycle and across a company’s portfolio, quality risk management and knowledge management will enable more agile manufacturing and better quality standards in the future.
Oct 01, 2018
BioPharm International
Susan Schniepp, executive vice-president of Post-Approval Pharma and Distinguished Fellow, Regulatory Compliance Associates, takes a look at the regulations around data integrity and how they relate to the concept of quality culture.
Oct 01, 2018
BioPharm International
Analytical exoglycosidases are transitioning from being largely academic tools to being suitable for glycan analytics in biopharmaceutical manufacturing.
Oct 01, 2018
BioPharm International
This article explores the use of single-use mixing technology in a detergent-based virus inactivation step during a monoclonal antibody production process.
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