Quality Assurance Units must provide assurance that the validation process has produced the expected results as per the requirements of USP General Chapter <233> Elemental Impurities in accordance with <1225> Validation of compendial procedures
Pharmaceutical products should contain low levels of residual solvents as determined by safety data. The presence of residual solvents in pharmaceutical products needs to be determined through testing
As development of biologics and biosimilars forges on, the autoinjector remains on the rise. Industry shifts to deterministic test methods translate to a need to develop and validate methods for autoinjectors
Three years ago, the executive management of Whitehouse Laboratories implemented a major reorganization plan. Over the previous ten years, the company had experienced many areas of growth to include e
CCIT programs in lifecycle of a product-package system; from development of the package, to stability, to analysis of package integrity after distribution cycles. As related to proposed revisions to USP 1207
In the past four or so years working with clients to develop and validate container closure integrity (CCI) test methods, there have been a number overarching trends that have become readily apparent.