Process Validation

Jan 08, 2014
By Pharmaceutical Technology Editors
EMA has launched a new version of the EudraGMDP database, which includes the publication of statements of non-compliance with good manufacturing practice.
Oct 28, 2013
By Pharmaceutical Technology Editors
Zhoydro ER is the first drug to have updated labeling now required for all ER/LA opioid analgesics.
Oct 22, 2013
By Pharmaceutical Technology Editors
FDA is seeking a permanent injunction against a dietary supplement manufacturer following the company?s repeated distribution of unapproved drugs and adulterated dietary supplements.
Oct 07, 2013
By Pharmaceutical Technology Editors
During the ongoing federal government shutdown, FDA activities will be limited to work involving the safety of human life or the protection of property, and activities funded by carryover user fee balances PDUFA, GDUFA, and MDUFA.
Oct 02, 2013
Pharmaceutical Technology
The authors evaluated a variety of materials of construction (MOCs) and found that visible residue limits (VRLs) were higher on some MOCs than on stainless steel. The optimal viewing conditions were dependent on the MOC and the viewing background. The risk of a cleaning failure due to visual failure for different MOCs can be mitigated or eliminated using complementary cleaning validation studies.
Sep 18, 2013
By Pharmaceutical Technology Editors
Shamrock Medical Solutions Group, a drug repackaging and distribution company, repeatedly failed to comply with good manufacturing practices.
Aug 28, 2013
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Installation of a quaternary chiral center with high enantioselectivity using memory of chirality enabled the six-step synthesis of the desired active compound.
Aug 14, 2013
By Pharmaceutical Technology Editors
CDER withdraws some outdated guidance documents and makes plans to finalize others.
Jul 02, 2013
By Pharmaceutical Technology Editors
Falsified Medicines Directive requires imported APIs to have written confirmation of GMP standards.
Jun 12, 2013
By Pharmaceutical Technology Editors
ISPE study reveals quality systems of manufacturing as the leading cause of drug shortages.
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