GMPs

Jun 15, 2017
By Pharmaceutical Technology Editors
The company has extended its voluntary recall of one lot of paliperidone extended-release tablets to the consumer level due to dissolution test failure.
Jun 14, 2017
By Pharmaceutical Technology Editors
FDA sent a warning letter to drug compounder DCA, Inc. dba Beacon Prescriptions for failing to ensure sanitary conditions.
Jun 14, 2017
By Pharmaceutical Technology Editors
The agency sent a warning letter to A-S Medication Solutions LLC after it found the company didn’t comply with drug listing file requirements.
Jun 06, 2017
By Pharmaceutical Technology Editors
Yusef Manufacturing Laboratories, LLC received an FDA warning letter citing CGMP violations at its Clearfield, UT facility.
Jun 05, 2017
The author shares his opinion on the challenges presented by the Internet of Things and what companies need to consider when choosing suitable architectures to manage serialization data.
Jun 02, 2017
Pharmaceutical Technology
Informing your clients of possible changes in equipment is imperative when upgrading a laboratory, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
Jun 02, 2017
Pharmaceutical Technology
The authors summarize the current regulatory expectations regarding the number of PPQ batches required and provide potential approaches that can be used to determine and justify the number of PPQ batches.
Jun 02, 2017
Pharmaceutical Technology
Approval of breakthrough therapies requires expedited quality assessment.
Jun 02, 2017
Pharmaceutical Technology
Serialization and complementary authentication technologies are needed in order to meet DSCSA and FMD regulations.
May 30, 2017
By Pharmaceutical Technology Editors
The company was cited for cGMP violations at its Irvine, California facility.
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