Regulatory/GMP Compliance

Jun 01, 2017
BioPharm International
Informing your clients of possible changes in equipment is imperative when upgrading a laboratory, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
Jun 01, 2017
BioPharm International
This article reviews systems and processes that enable a laboratory to approach troubleshooting in an effective way, while also taking a proactive, preventive approach to managing atypical laboratory scenarios.
May 09, 2017
By BioPharm International Editors
FDA sent a warning letter to Pharmaceutic Labs, LLC for deficiencies in producing sterile drugs.
May 05, 2017
By BioPharm International Editors
The agency sent a warning letter to Sal Pharma for not disclosing information about API manufacturers to customers.
May 01, 2017
BioPharm International
The unique structures of fusion proteins lead to expression, heterogeneity, and stability issues.
May 01, 2017
BioPharm International
New study will reveal bio/pharma practices and performance on quality issues.
May 01, 2017
BioPharm International
Can bioprocessing runs be consistently replicated in an inherently variable production environment?
Apr 13, 2017
Pharmaceutical Technology spoke with CPhI North America presenter Jonathan Helfgott to discuss navigating GDUFA and helpful tips for submitting successful ANDAs.
Apr 12, 2017
By BioPharm International Editors
The new guide offers guidance on how to ensure data and records are complete, consistent, secure, accurate, and available throughout their lifecycle.
Apr 01, 2017
BioPharm International
Understanding the purpose of the biological indicator can guide the development of an effective sterilization process.
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