GMPs

Pharmaceutical Technology: Apr 16, 2015
By Pharmaceutical Technology Editors
At the request of FDA, US Marshals seize unapproved prescription drugs from Florida distributor.
Pharmaceutical Technology: Apr 10, 2015
By Pharmaceutical Technology Editors
FDA issues a Warning Letter to Hospira S.p.A. for GMP violations at the company’s Liscate, Italy facility.
Pharmaceutical Technology: Apr 02, 2015
Process design experimental data and risk assessments are used to predict expected process performance and establish process performance qualification acceptance criteria.
PTSM: Pharmaceutical Technology Sourcing and Management: Mar 30, 2015
By Pharmaceutical Technology Editors
A consensus-based standard issued by NSF International incorporates regulatory and industry requirements into a single standard for the manufacturing and distribution of pharmaceutical excipients.
Mar 13, 2015
By Pharmaceutical Technology Editors
McNeil-PPC pleads guilty in connection with adulterated infants' and children's over-the-counter liquid medications.
Pharmaceutical Technology: Mar 02, 2015
Cleanability is crucial when choosing components for GMP manufacturing areas.
Pharmaceutical Technology: Feb 24, 2015
By Pharmaceutical Technology Editors
The company voluntarily recalls product due to FDA observations of potential sterility problems.
Pharmaceutical Technology: Feb 23, 2015
By Pharmaceutical Technology Editors
The agency cites Apotex’s Bangalore facility with quality system failures.
Pharmaceutical Technology: Feb 02, 2015
Biosimilars, supply chain security, quality metrics, and elemental impurities headline guidance topics on FDA’s 2015 agenda.
PTSM: Pharmaceutical Technology Sourcing and Management: Dec 31, 2014
By Pharmaceutical Technology Editors
Analytical and procedural deficiencies result in FDA warning letter for Novacyl Wuxi Pharmaceutical.