Standards & Regulations

May 02, 2018
Pharmaceutical Technology
The approach presented in this study uses process capability index results to establish sampling strategies for use with new product cleaning and to efficiently reduce the risk of insufficient cleaning.
May 02, 2018
Pharmaceutical Technology
Monetary benefits will outweigh the hassle of batch record harmonization, says Siegfried Schmitt, principal consultant at PAREXEL.
May 02, 2018
Pharmaceutical Technology
FDA’s commissioner addresses opioid abuse, drug costs, and manufacturing quality.
May 02, 2018
Pharmaceutical Technology
Updated guidelines and new technologies aid visual inspection of parenteral products and packaging.
Apr 30, 2018
By Pharmaceutical Technology Editors
The company received a complete response letter from FDA in response to the biologics license application for a proposed trastuzumab biosimilar.
Apr 30, 2018
By Pharmaceutical Technology Editors
After a review of public comments, USP will not move forward with nomenclature proposal without further FDA collaboration.
Apr 30, 2018
By Pharmaceutical Technology Editors
The agency updated its list of recommended influenza virus strains that manufacturers should include in vaccines for the autumn 2018 season.
Apr 30, 2018
By Pharmaceutical Technology 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 Pharmaceutical Technology Editors
EMA and its new host country have finalized the terms of the agency’s relocation to Amsterdam.
Apr 20, 2018
By Pharmaceutical Technology Editors
FDA’s Center for Drug Evaluation and Research has published its second annual report on key safety programs and activities.
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