Regulatory/GMP Compliance

Jul 06, 2016
By BioPharm International Editors
FDA cited Guangzhou Haishi Biological Technology Co., Ltd. with CGMP violations.
Jul 01, 2016
BioPharm International
Agency guidance and industry standards aim to reduce lapses and improve quality operations.
Jul 01, 2016
BioPharm International
A streamlined approach may enhance process efficiency and product quality.
Jul 01, 2016
BioPharm International
The author provides a review of the concepts of design and qualification that apply to single-use systems.
Jul 01, 2016
BioPharm International
Revised versions of ISO 14644 Parts 1 and 2 introduce changes to sampling procedures and monitoring plans for cleanrooms and clean zones.
Jun 24, 2016
By BioPharm International Editors
The agency publishes draft reference material for implementation of FDA’s quality metrics guidance.
Jun 15, 2016
By BioPharm International Editors
FDA cited a Las Vegas compounding pharmacy for sterility violations.
Jun 15, 2016
By BioPharm International Editors
FDA sent a warning letter to The Compounding Pharmacy of America for deficiencies in sterile manufacturing.
Jun 09, 2016
By BioPharm International Editors
The agency publishes three final guidance documents on drug compounding.
Jun 09, 2016
Sharing un-redacted inspection reports between FDA and EMA may reduce duplicate inspections of facilities.
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