GMPs

May 23, 2017
By Pharmaceutical Technology Editors
FDA cited the facility for violations of quality management and data integrity CGMPs.
May 16, 2017
Archana M. Akalkotkar, PhD, research scientist I at Charles River, discusses the use of process validation to ensure quality.
May 15, 2017
Pharmaceutical Technology
Manufacturing for originator molecules is restricted by regulations, but drug makers can exploit newer technologies for the manufacture of biosimilars.
May 05, 2017
By Pharmaceutical Technology Editors
The agency sent a warning letter to Sal Pharma for not disclosing information about API manufacturers to customers.
May 02, 2017
Pharmaceutical Technology
In this study, the authors investigated the relationship between the 0.001 MinDD and the PDE values for 140 drug substances as an attempt to identify high-risk groups of products for patient safety. This comparison can serve as a method for prioritization of APIs for development of PDEs.
May 02, 2017
Pharmaceutical Technology
Solid-phase extraction has several advantages over liquid/liquid extraction for extractables and leachables studies.
May 02, 2017
Pharmaceutical Technology
The author discusses the impact of prefilled syringe product contact materials and the filling and stoppering process on protein aggregates.
May 02, 2017
Pharmaceutical Technology
New study will reveal bio/pharma practices and performance on quality issues.
May 02, 2017
Pharmaceutical Technology
Advances in chemical synthesis are enabling greener, more cost-efficient processes for API manufacturing.
May 02, 2017
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Siegfried Schmitt, PhD, Principal Consultant at PAREXEL, discusses how to gain benefits from interactions with industry associations.
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