All manufacturers are expected to establish some form of quality protocols to ensure that products meet a minimum standard, whether that threshold is … [Read more...] about Good Manufacturing Practice in the Medical Device Industry
Read our blog posts on analytical chemistry lab testing and how it helps companies answer polymer questions.
What GMP Means in Pharma
The acronym GMP refers to the good manufacturing practices promoted by the U.S. Food and Drug Administration (FDA) under the remit of the FD&C … [Read more...] about What GMP Means in Pharma
How to Avoid Regulatory Deficiencies in Extractables and Leachables Testing
Pharmaceuticals and other chemical products can potentially come into contact with thousands of other chemical species in their lifetime. Container … [Read more...] about How to Avoid Regulatory Deficiencies in Extractables and Leachables Testing
Reducing Relative Response Factor Variation in E&L Testing
E&L testing involves investigating extractables from the product related to its materials of construction or trace impurities that may come from … [Read more...] about Reducing Relative Response Factor Variation in E&L Testing
Risk Assessment Strategies in Extractables and Leachables
Risks assessments are a key element in extractables and leachables testing. There are many factors involved in ascertaining the specific risks and how … [Read more...] about Risk Assessment Strategies in Extractables and Leachables
