Regulatory/GMP Compliance

Dec 13, 2017
By BioPharm International Editors
The European Medicines Agency has granted Samsung BioLogics approval to manufacture a monoclonal antibody at the company’s second facility in Songdo, Incheon, South Korea.
Dec 07, 2017
An increasing number of warning letters shows that FDA is observing more problems with pharmaceutical contract manufacturing.
Dec 01, 2017
BioPharm International
SOPs need to reflect a company’s specific manufacturing or other operations, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
Nov 01, 2017
BioPharm International
Rinse sample analysis or visual inspection are risk-based approaches that can be correlated to surface cleanliness to replace surface sampling in a biopharmaceutical equipment cleaning process.
Nov 01, 2017
BioPharm International
The level of formality in change control may be holding back your SOP progress, according to Siegfried Schmitt, principal consultant at PAREXEL.
Oct 31, 2017
By BioPharm International Editors
A mutual recognition agreement to accept inspection data from eight EU regulatory authorities may reduce inspection burdens at global drug facilities.
Oct 25, 2017
By BioPharm International Editors
FDA sent a warning letter to Ridge Properties, LLC, after inspectors found a variety of current good manufacturing practice violations at the company’s Salem, OR facility.
Oct 24, 2017
This article examines how process characterization is crucial to process understanding and then applying that understanding to controlling a process.
Oct 05, 2017
By BioPharm International Editors
Both regulatory bodies are working on enhancements to their respective adverse event reporting systems in efforts to increase transparency and safety monitoring of drugs.
Sep 28, 2017
By BioPharm International Editors
The draft guidance gives recommendations for reproductive toxicity testing and labeling.
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