Quality Control/Quality Assurance

Nov 14, 2018
By BioPharm International Editors
The agency sent a warning letter to the company for marketing an unapproved stem cell product and CGMP violations.
Nov 12, 2018
By BioPharm International Editors
The agency is developing a new way to assess, record, and report data from surveillance and preapproval inspections of sterile drugs.
Nov 09, 2018
By BioPharm International Editors
The new program will provide cell and gene therapy companies a more efficient way to ensure quality compliance across collection center networks and to minimize quality system audit burden on these centers.
Nov 01, 2018
BioPharm International
The second half of this article describes the testing methods used by the authors to demonstrate the applicability of single-use mixing technology for virus inactivation.
Nov 01, 2018
BioPharm International
This article will explore the requirements for media and supplements needed to maintain newer cell lines, such as those based on human cells and fungal cells.
Nov 01, 2018
BioPharm International
Industry is searching for ways to deal with the criticality of ensuring data integrity.
Nov 01, 2018
BioPharm International
Building up relevant expertise in-house will make writing spec sheets for software easier, according to Siegfried Schmitt, principal consultant at PAREXEL.
Oct 15, 2018
BioPharm International
The testing of raw materials is essential as raw material quality determines the outcome of biologic product quality.
Oct 15, 2018
BioPharm International
Providing analytical data on the comparison between a biosimilar and the reference product is a primary consideration in the development of biosimilars.
Oct 01, 2018
BioPharm International
Susan Schniepp, executive vice-president of Post-Approval Pharma and Distinguished Fellow, Regulatory Compliance Associates, takes a look at the regulations around data integrity and how they relate to the concept of quality culture.
native1_300x100
lorem ipsum