Pharmaceutical Product Risk Assessments
Assessing the potential risk a product might pose to patient safety is an iterative process that should continue throughout the product’s lifecycle:
Development – Early risk assessments can help inform a focused safety monitoring plan.
Preparing a New Drug or Biologic Licensing Application – Utilize clinical data to assess and support proposed product specifications.
Post-approval Monitoring – Establish surveillance programs for product quality-related events.
Manufacturing Process Changes – Develop datamining paradigms to monitor post-change adverse events and product quality attributes.
For-cause Assessments – Manufacturing deviations or excursions including contaminants, decomposition, environmental stresses, atypical stability testing results.
Early identification and assessment of the drug substance, drug product and primary packaging component attributes are the key to establishing a comprehensive safety plan for clinical studies. Ongoing review then supports the product’s continued safe-use.