Regulatory/GMP Compliance

Jan 01, 2018
BioPharm International
Open standards based on GAMP and GS1 will soon be released and more companies are moving beyond basic compliance.
Jan 01, 2018
BioPharm International
A review of 2017 advancements from the Open-SCS working group with Charlie Gifford, group technical director.
Jan 01, 2018
BioPharm International
Pharmaceutical companies and contract manufacturing organizations report lack of readiness for the US Drug Supply Chain Security Act serialization deadline.
Dec 28, 2017
By BioPharm International Editors
The recall was initiated due to a product complaint in which white particulate matter, identified as mold, was discovered in a flexible bag from one batch.
Dec 20, 2017
By BioPharm International Editors
FDA sent a warning letter to Deserving Health International Corp. after inspectors found CGMP violations including failure to prevent microbiological contamination.
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.
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