Quality Systems

Aug 01, 2017
BioPharm International
Investigational failures and discrepancies can be avoided through the proper execution and documentation of investigations.
Aug 01, 2017
BioPharm International
Managing and prioritizing risk is essential to ensuring raw material quality. USP is developing new guidelines to make the work easier.
Jul 31, 2017
By BioPharm International Editors
Stainless-steel particulates were found in one lot of 0.9% Sodium Chloride Injection, USP 1000 mL, prompting the recall to the hospital/user level.
Jul 26, 2017
Weak or faulty quality systems can hurt a company at every stage of a product’s lifecycle.
Jul 21, 2017
By BioPharm International Editors
Updated ISPE guidance offers risk assessment guidance to avoid cross contamination in multiproduct pharmaceutical manufacturing facilities.
Jul 21, 2017
By BioPharm International Editors
The agency will lead an international team to create a Supply Chain Security Toolkit of resources to educate the pharmaceutical and healthcare industries on supply chain vulnerabilities.
Jul 12, 2017
By BioPharm International Editors
One day after Ocular Therapeutix sent FDA a detailed response highlighting manufacturing improvements, FDA rejected its application for Dextenza, a new drug designed to alleviate post-operative eye pain.
Jul 10, 2017
By BioPharm International Editors
FDA sent a warning letter to Shandong Analysis and Test Center for CGMP violations including data integrity issues and insufficient testing procedures.
Jul 01, 2017
BioPharm International
Short tandem repeat profiling is the most validated method to confirm cell line identity and avoid misidentified or cross-contaminated cell lines.
Jul 01, 2017
BioPharm International
Electronic systems can remove opportunities for individuals to make mistakes or to manipulate the data.
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