Quality Systems

Apr 30, 2018
By BioPharm International Editors
FDA sent a warning letter to Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. for failure to follow current good manufacturing practices.
Apr 24, 2018
By BioPharm International Editors
EMA and its new host country have finalized the terms of the agency’s relocation to Amsterdam.
Apr 20, 2018
By BioPharm International Editors
FDA’s Center for Drug Evaluation and Research has published its second annual report on key safety programs and activities.
Apr 20, 2018
By BioPharm International Editors
The agency has released new guidance on the development of new medication-assisted treatments for opioid dependence.
Apr 19, 2018
By BioPharm International Editors
The agency has granted breakthrough therapy designation to Roche’s hemophilia therapy for treating hemophilia A in patients without factor VIII inhibitors.
Apr 19, 2018
By BioPharm International Editors
The new document answers questions regarding implementation of the ICH Q7 guidance on GMPs for APIs.
Apr 16, 2018
By BioPharm International Editors
A new report gives an overview of the work of the International API Inspection Program.
Apr 13, 2018
By BioPharm International Editors
Premier Pharmacy Labs is voluntarily recalling multiple products because of the potential lack of sterility assurance.
Apr 11, 2018
By BioPharm International Editors
The agency has assigned new EU member state rapporteurs and co-rapporteurs to medicines previously assigned to the UK’s Medicines and Healthcare products Regulatory Agency.
Apr 11, 2018
By BioPharm International Editors
FDA sent a warning letter to Tris Pharma Inc. after investigators found the company had failed to properly investigate batch failures and establish quality control procedures.
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