Regulatory/GMP Compliance

Nov 17, 2016
By BioPharm International Editors
At ICH’s November 2016 meeting, the council announced new members and new guidelines.
Nov 17, 2016
By BioPharm International Editors
The agency published guidance to help pharma companies in the clinical development of treatments for bacillus Calmette-Guerin (BCG)-unresponsive nonmuscle invasive bladder cancer.
Nov 03, 2016
By BioPharm International Editors
FDA puts Beijing Taiyang Pharmaceutical Industry Co. on import alert after company refuses access to inspectors.
Nov 01, 2016
BioPharm International
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 single-use technology.
Oct 26, 2016
By BioPharm International Editors
The Czech Republic drug manufacturer was cited for data integrity and quality issues.
Oct 15, 2016
BioPharm International
Experts discuss recent advances in cell viability testing methods in bioreactors.
Oct 15, 2016
BioPharm International
Classical production in cell-based systems such as mammalian and bacterial cells requires cell line development and lengthy process development to support scale-up. With plant technology, generic plant bioreactors can be grown rapidly and then transfected with a transient vector based system to produce proteins in days. Large-scale commercial facilities are now available in the US, enabling clinical or commercial production of significant quantities of therapeutic materials within a year.
Oct 15, 2016
BioPharm International
Designing systems using the principles of good documentation practice, including validated audit trails, is a key piece of a manufacturing data integrity program.
Oct 15, 2016
BioPharm International
Are investigations supporting or hindering performance excellence?
Oct 03, 2016
By BioPharm International Editors
The guidance addresses the good manufacturing practice for managing quality in APIs.
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