Process Validation

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CDER withdraws some outdated guidance documents and makes plans to finalize others.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.
Jun 05, 2013
The company is cited for using unapproved visual-inspection methods for finished parenteral drugs and conducting inadequate visual inspections.
May 28, 2013
Company receives notice from FDA for not fully investigating foreign particles in APIs and finished products made from its facility in Ingelheim am Rhein, Germany.
Apr 12, 2013
By Pharmaceutical Technology Editors
Prefilled-syringe line features automation and novel disinfection techniques.
Mar 29, 2013
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Victor Hernandez of EMD Millipore discusses his upcoming session, "Current continuous process validation program: following FDA current guidelines,? which will be held at Interphex 2013
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