Quality Systems

Jul 07, 2015
The amendment suggests modifications to the calculation of a drug's average manufacturing price and to the reimbursement rate for infused medications.
Jul 02, 2015
BioPharm International
Siegfried Schmitt, principal consultant, PAREXEL, discusses how to handle internal audit reports during inspections.
Jul 01, 2015
BioPharm International
Manufacturers and FDA look for innovative strategies to meet accelerated timeframes.
Jul 01, 2015
BioPharm International
The European Union has a challenging task ahead as it strives to harmonize regulations on advanced therapy medicinal products.
Jul 01, 2015
BioPharm International
Advances in adventitious agent detection methodology are bringing benefits, but more work needs to be done.
Jul 01, 2015
BioPharm International
The challenges and strategies of assessing and mitigating risk in biopharmaceutical manufacturing are discussed.
Jun 29, 2015
By BioPharm International Editors
The International Conference on Harmonization Steering Committee appoints Dr. Dawn Ronan as the new director of the ICH Secretariat.
Jun 29, 2015
By BioPharm International Editors
The US Pharmacopeial Convention hosts compliance seminar at CPhI China 2015.
Jun 25, 2015
By BioPharm International Editors
Pharmacy associates say more education regarding the transactional requirements of DSCSA is needed.
Jun 24, 2015
By BioPharm International Editors
The agency clarifies its requirements for allowable excess volume and labeled vial fill size in injectables and biologics.
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