Quality

Jul 27, 2016
The move follows a warning from FDA wherein FDA cited ALK-Abello with numerous manufacturing violations.
Jul 22, 2016
By BioPharm International Editors
The agency recommends suspending drugs developed with bioequivalence studies performed at Semler Research Centre Private Ltd, Bangalore, India.
Jul 19, 2016
By BioPharm International Editors
FDA issued a warning letter to the Worthing, UK facility for cross contamination and microbial contamination cGMP violations.
Jul 06, 2016
By BioPharm International Editors
The draft guidance addresses control of elemental impurities in harmonization with implementation of ICH Q3D guideline.
Jul 01, 2016
BioPharm International
The author addresses critical issues to consider prior to performing forced degradation studies and provides best practice recommendations for these types of studies.
Jul 01, 2016
BioPharm International
A streamlined approach may enhance process efficiency and product quality.
Jul 01, 2016
BioPharm International
The author provides a review of the concepts of design and qualification that apply to single-use systems.
Jun 24, 2016
By BioPharm International Editors
The agency publishes draft reference material for implementation of FDA’s quality metrics guidance.
Jun 24, 2016
By BioPharm International Editors
The agency has suspended recommendation of Riluzole Alkem due to flawed study results.
Jun 15, 2016
BioPharm International eBooks
Biopharmaceutical manufacturers continue to put quality at the forefront of their relationships.
lorem ipsum