Regulatory Compliance

Our experts can help you achieve regulatory compliance by conducting extractables and leachables assessments in accordance to regional guidance and regulatory specifications.

We will work with you to assess your specific needs to make sure your product achieves compliance in whatever market you're working in. Our labs in the US and the UK are fully equipped to carry out a full range of assessments pertaining to:

  • United States Pharmacopeia (USP) general chapters
  • Food and Drug Administration (FDA) requirements
  • Medicines and Healthcare Products Regulatory Agency (MHRA) requirements
  • Europen Medicines Agency (EMA) requirements
  • Product Quality Research Institute (PQRI) recommendations
  • BioPhorum Operations Group (BPOG) guidelines

We can provide an extractables and leachables analysis to demonstrate product and material compliance with:

  • USP <1661> Evaluation of Plastic Packaging Systems and Their Materials of Construction with Respect to Their User Safety Impact
  • USP <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems
  • USP <1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems
  • USP <232> Elemental Impurities
  • USP <381> Elastomeric Closures for Injections
  • USP <661> Containers – Plastic
  • USP <661.1> Plastic Materials of Construction
  • USP <661.2> Plastic Packaging Systems for Pharmaceutical Use
  • USP <665> Plastic Components and Systems Used in Pharmaceutical Manufacturing
  • USP <671> Containers – Performance Testing
  • BPOG single use extractables studies

Your testing program will be custom designed to meet your exact needs and ensure that your regulatory requirements are fulfilled. 

 For more information or to request a quote, contact us.