Quality Systems

Sep 01, 2018
BioPharm International
The US Pharmacopeial Convention (USP) is developing a new chapter for rapid sterility testing of short-life products based on the recommendations of a panel of experts and stakeholders.
Sep 01, 2018
BioPharm International
This study was successful in establishing a reliable and effective method for evaluating cleaning processes based on risk.
Sep 01, 2018
BioPharm International
Viral vaccines and viral vectors used in biotherapeutic applications carry the risk of microbial contamination, which must be addressed.
Sep 01, 2018
BioPharm International
Trace elements in raw materials may impact the quality and safety of the finished biologic product, according to industry experts.
Sep 01, 2018
BioPharm International
The development and optimization of an efficient conjugation process involves identifying the critical quality attributes and monitoring critical process parameters.
Sep 01, 2018
BioPharm International
Detailed process descriptions and robust documentation aid in compliance as well as training, says Siegfried Schmitt, principal consultant at PAREXEL.
Sep 01, 2018
BioPharm International
Automation can improve many aspects of bioprocessing, but several hurdles must be overcome before the full range of benefits can be realized.
Sep 01, 2018
BioPharm International
Sharing of bioprocessing know-how can help resolve pressing industry problems.
Sep 01, 2018
BioPharm International
More consistent and reliable production processes are critical for advancing innovative treatments.
Aug 29, 2018
By BioPharm International Editors
PDA Technical Report 80 (TR 80): Data Integrity in Laboratory Systems is the first in a series of three technical reports PDA will publish on data integrity.
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