GMPs

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The draft guidance addresses control of elemental impurities in harmonization with implementation of ICH Q3D guideline.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.
Jul 02, 2016
Pharmaceutical Technology
China and India are also increasing inspections and becoming more exigent about data integrity and cGMPs.
Jul 02, 2016
Pharmaceutical Technology
Early planning for the integration of clean-in-place systems for equipment cleaning is key.
Jul 02, 2016
Pharmaceutical Technology
Designing systems using the principles of good documentation practice, including validated audit trails, is a key piece of a manufacturing data integrity program.
Jul 02, 2016
Pharmaceutical Technology
Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses standard operating procedures for the regulatory affairs department.
Jul 02, 2016
Pharmaceutical Technology
Agency guidance and industry standards aim to reduce lapses and improve quality operations.
Jun 02, 2016
Pharmaceutical Technology
Industry experts discuss common considerations and recent technological advancements in blow-fill-seal technology.
Jun 01, 2016
Pharmaceutical Technology
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses training personnel on data integrity.
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