Extractables & Leachables Risk Assessment for Pharmaceutical Products

Toxicology-driven extractables and leachables risk assessment to support patient safety, regulatory submissions, and inspection readiness.

Bioexcel supports pharmaceutical manufacturers


Bioexcel supports pharmaceutical manufacturers in assessing and documenting extractables and
leachables (E&L) risks associated with drug products, container closure systems, packaging materials, and manufacturing equipment.

Our E&L services focus on toxicological evaluation and regulatory justification, ensuring that analytical findings are translated into clear safety conclusions suitable for regulatory submissions, audits, and inspections.

All assessments are performed using a science-based, risk-driven, and regulator-aligned approach consistent with EMA and FDA expectations.

WHAT WE SUPPORT

  • Extractables & leachables risk assessment strategy
  • Toxicological evaluation of identified compounds
  • PDE / TTC-based safety justification
  • Regulatory documentation and responses
  • Inspection and audit readiness

Extractables & Leachables Services

Extractables & Leachables Risk Identification

Systematic identification and assessment of potential extractables and leachable arising from: – Primary and secondary packaging materials – Container closure systems Manufacturing equipment and components
Risk assessment considers intended use, route of administration, dosing, and patient exposure.

Toxicological Evaluation of E&L Compounds

Toxicological assessment of identified extractables and leachables using: – Available toxicological data -Structure Activity Relationship (SAR) analysis – Threshold of Toxicological Concern (TTC) principles to support patient safety justification.

PDE / TTC-Based Risk Justification

Derivation and justification of Permitted Daily Exposure (PDE) values or TTC-based thresholds to determine acceptable exposure levels for identified leachables.
Prepared in line with regulatory expectations.

Regulatory Documentation & Reporting

Preparation of: – Extractables & leachables risk assessment reports – Toxicological summaries for regulatory submissions – Inspection-ready justifications and responses
Documentation is structured to support authority review.

Alignment & Documentation

Regulatory & Guidance Alignment

Extractables & leachables services are aligned with: – EMA and EU regulatory expectations – FDA guidance on extractables and leachables – ICH Q3C / Q3D principles (where applicable) -Toxicological risk assessment
best practices

Integration with Pharma Compliance Activities

Built for Inspections and Audits

E&L risk assessment outputs integrate with: – PDE, OEL & CLP (Pharma) – Cleaning Validation (Pharma) -Nitrosamine Risk Assessment
Ensuring consistency of toxicological justification across all pharma compliance activities

Who This Service Is For

  • Pharmaceutical manufacturers
  • API and formulation companies
  • Quality Assurance and Regulatory Affairs teams
  • Packaging development teams

Why Bioexcel

  • Dedicated pharma toxicology expertise
  • Regulator-aligned E&L risk assessment methodology
  • Inspection-ready documentation
  • Clear separation from medical device extractables and leachable

Manage Extractables & Leachable Risks with Confidence

Bioexcel helps pharmaceutical companies translate complex extractables and leachables data into clear, regulator-ready toxicological conclusions.