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GMPs

Aug 17, 2016
By Pharmaceutical Technology Editors
The Chinese facility was cited for data integrity violations.
Aug 15, 2016
By Pharmaceutical Technology Editors
The agency has adopted guidelines on the pharmacovigilance of biological drugs.
Aug 11, 2016
By Pharmaceutical Technology Editors
The agency released the GMP guidance to help manufacturers ensure accurate data and minimize risk.
Aug 10, 2016
By Pharmaceutical Technology Editors
FDA issued a warning letter to contract testing laboratory, Adamson Analytical Laboratories, for CGMP violations.
Aug 02, 2016
Pharmaceutical Technology
Conventional limit-setting techniques are not health-based and can make risk assessment more difficult.
Aug 02, 2016
Pharmaceutical Technology
Recent revisions to the European Union’s good distribution practices, which were updated in 2013, reflect increased regulatory focus on the supply chain.
Aug 02, 2016
Pharmaceutical Technology
Airlines, airports, freight forwarders, and other cold-chain partners are taking a crash course in pharma cGMPs.
Jul 06, 2016
By Pharmaceutical Technology Editors
FDA cited Guangzhou Haishi Biological Technology Co., Ltd. with CGMP violations.
Jul 06, 2016
By Pharmaceutical Technology Editors
The draft guidance addresses control of elemental impurities in harmonization with implementation of ICH Q3D guideline.
Jul 02, 2016
Pharmaceutical Technology
Data integrity and cGMP issues demand closer scrutiny of suppliers. Bribery and corruption may become the next supply chain flashpoint.
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