Real-Time Monitoring Of Pharmaceutical Shipments

In today’s technologically advanced world, real-time monitoring of pharmaceutical shipments is crucial. Ensuring the integrity of sensitive, high-value products requires strict adherence to procedures and policies. At Singota Solutions (Bloomington, Indiana CDMO), we excel in managing the complexities of the pharmaceutical supply chain. With our GMP compliant warehouse and expertise…

Analysis Paralysis: Navigating Early-Phase Analytical Validation

Source: Singota Solutions By Dustin Lafferty, Singota Solutions Significant confusion persists across the pharmaceutical/biopharmaceutical industry relevant to early-phase analytical development and validation. While several guidance documents serve as a de facto standard, distinguishing method validation requirements from suggestions, when and how to apply those guidelines often is not a straightforward task.…

Which Testing Does An Effective Certificate Of Analysis Include?

Source: Singota Solutions By Ken Chomistek, Singota Solutions Compendial monograph (pharmacopeial) testing applied to pharmaceutical raw materials and finished drug products is a critical element of drug development. A testing record is created in the form of a Certificate of Analysis (CoA) for manufacturing release and distribution. However, the testing required…