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 – risk assessments can help inform the safety monitoring plan.
- Preparing a New Drug Application – provide input supporting proposed specifications.
- Post-approval Monitoring – Establishing surveillance programs for product quality-related events.
- Manufacturing Process Changes – Adopting datamining paradigms to monitor post-change event reports.
- 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 components attributes are the key to informing the safety plan in clinical studies. Ongoing review supports the product’s continued safe-use.