Regulatory/GMP Compliance

Jul 01, 2008
BioPharm International
By BioPharm International Editors
Quality by Design and Design Space can be used by companies to enhance process understanding, improve scientific rigor, and enhanced qualitative and quantative performance, as well as cost savings.
Jun 01, 2008
BioPharm International
By BioPharm International Editors
The industry needs to open up to validation failures.
Jun 01, 2008
BioPharm International
The comparative research approach may be preferable to price controls in the guise of government negotiations for the Medicare drug benefit, coverage denials, and limits on access to new technologies.
May 01, 2008
BioPharm International
By BioPharm International Editors
Recent problems with food and pharmaceutical ingredients sourced from China highlight a major disadvantage of our complex international supply chains for food and drug ingredients. A global supply chain offers more opportunities for accidental contamination as well as intentional adulteration and counterfeiting. Sticking to minimal requirements may not be enough.
May 01, 2008
BioPharm International
The current overcapacity situation in the bio/pharmaceutical industry is a reminder that CMOs need to come up with business models and value propositions that are based on more than just selling capacity.
May 01, 2008
BioPharm International
By BioPharm International Editors
The principles of QbD can be applied to biotech development and manufacturing to help resolve many common issues. QbD scientifically provides a greater understanding of the complex relationships among product quality attributes, the manufacturing process, and clinical safety and efficacy by determining the various permutations of critical input variables that will keep the product within specification.
Apr 09, 2008
In its effort to ensure that consistent definitions of terminology are being applied by all constituents of the ICH, the FDA has released a new guidance, E15, containing definitions of key terms in the discipline of pharmacogenomics and pharmacogenetics.
Apr 02, 2008
BioPharm International
When a biopharmaceutical company pursues an outsourcing strategy, the choice of a contractor is a critical and strategic decision.
Apr 02, 2008
BioPharm International
After a strategic evaluation of what activities to outsource, sponsor companies should follow key guidelines for selecting and auditing a provider and preparing quality agreements.
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