Effective pharmaceutical regulation protects public health by ensuring that medicines are of the required quality, safety, and efficacy.

Regulatory bodies require extractables and leachables assessments and testing to be conducted according to the most current regulations and best practices. New specifications are continually incorporated into the existing standards to ensure that medicines are appropriately manufactured, stored, distributed and dispensed. The ultimate goal is to guide the industry to effective and safe product development, hence protecting public health.

Examples of new regulations are:

  • Revision of USP <661> Containers – Plastics. The extractables and leachables testing is now a component of USP <661.2> Plastic Packaging Systems for Pharmaceutical Use
  • General chapters for extractables and leachables testing:
    • USP <1663> Assessment of Extractbales Associated with Pharmaceutical Packaging/Delivery Systems
    • USP <1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging / Delivery Systems
  • Extractables Testing for Plastic Manufacturing Equipment – USP <665>, formerly <661.3>
  • Product Quality Research Institute (PQRI) best practices for parenteral and ophthalmic drug products – Final Recommendations Issued

When developing study plans for extractables and leachables testing, a “risk-based approach” is still expected to be taken. Lower risk dosage forms, such as oral and topical drug products, typically do not require formal extractables and leachables testing for the packaging and manufacturing components if their materials of construction comply with the Food and Drug Administration (FDA) food contact regulations.

Exova’s scientists are active participants in the working groups that have developed the current extractables and leachables best practices such as PQRI, USP Expert Panels, ELSIE, and BPOG.

We know when actual extractables and leachables testing is expected and when an assessment report will be sufficient to meet the regulatory expectations. When testing is required, we can design efficient customized protocols to meet your specific needs.