Standards/Regulations

Sep 15, 2017
Continued industry investment in advanced biologics will raise further regulatory challenges and require innovative manufacturing systems.
Sep 12, 2017
By Pharmaceutical Technology Editors
The agency is looking for industry input on best practices for continuous manufacturing.
Sep 12, 2017
By Pharmaceutical Technology Editors
The meeting, to be held jointly with the European Centre for Disease Prevention and Control, is part of the agency’s effort to raise awareness about the threat of antimicrobial resistance.
Sep 11, 2017
By Pharmaceutical Technology Editors
FDA cited Meridian Medical Technologies, a Pfizer company, which manufactures Mylan’s EpiPen, for cGMP violations that included failure to appropriately investigate defects in auto-injector components.
Sep 08, 2017
Six years after the guidance, it’s time to change our quality assurance vocabulary.
Sep 02, 2017
Pharmaceutical Technology
EMA recognizes that a regulatory framework, under which medicines and diagnostics are developed and approved independently, may not be ideal.
Sep 02, 2017
Pharmaceutical Technology
When it comes to getting the best out of quality by design, timing is everything.
Sep 02, 2017
Pharmaceutical Technology
FDA works with industry on strategies for assuring high-quality regenerative medicines.
Sep 02, 2017
Pharmaceutical Technology
The differences between the quality control and quality assurance units can be found in their names, according to Siegfried Schmitt, principal consultant at PAREXEL.
Sep 01, 2017
Pharmaceutical Technology
Regulatory outsourcing can result in improved compliance, greater transparency, higher productivity, increased cost-effectiveness, and desired strategic outcomes.
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