Quality Systems

Apr 01, 2017
BioPharm International
Understanding the purpose of the biological indicator can guide the development of an effective sterilization process.
Apr 01, 2017
BioPharm International
The complex nature of biologics adds additional CQAs that must be determined to ensure the safe development of biologics
Apr 01, 2017
BioPharm International
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the value of internal audits and how the information gained can be applied.
Apr 01, 2017
BioPharm International
As regulators strive for balance in cGMPs for cell, gene, and tissue therapies, risk-management principles must guide decisions involving process media and additives.
Apr 01, 2017
BioPharm International
The author discusses the impact of prefilled syringe product contact materials and the filling and stoppering process on protein aggregates.
Mar 28, 2017
By BioPharm International Editors
The agency sent a warning letter to Opto-Pharm Pte Ltd. after deficiencies in sterile manufacturing procedures were found at the company’s Singapore facility.
Mar 07, 2017
By BioPharm International Editors
The agency sent a warning letter to Chongqing Pharma Research Institute Co., Ltd. citing data integrity violations.
Mar 01, 2017
BioPharm International
Siegfried Schmitt, PhD, Principal Consultant at PAREXEL, discusses how to mitigate risk in a global regulatory environment.
Feb 28, 2017
By BioPharm International Editors
The agency cited the company’s Kansas facility with CGMP violations similar to problems found at other Hospira facilities.
Feb 27, 2017
By BioPharm International Editors
The company is voluntarily recalling one lot of Edex due to a lack of container closure integrity.
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