Identifying and assessing highly hazardous drugs within quality risk management programs

Area of Science:

• Pharmaceutical Science
• Toxicology
• Quality Risk Management

Background:

• Historical pharmaceutical industry guidelines used broad categories (e.g., "cytotoxic", "hormones") for active pharmaceutical ingredients (APIs).
• These categories were intended to guide segregation and dedication practices to prevent cross-contamination.
• The lack of regulatory definitions and evolving pharmacology challenge the utility of these traditional categories.

Observation:

• Novel pharmacological mechanisms increasingly blur the lines of historical API categories.
• A health-based limit, such as acceptable daily exposure (ADE), offers a more precise risk assessment tool.
• Quantitative risk assessments are crucial for controlling airborne concentrations and surface contamination.

Findings:

• A risk-based approach utilizing compound-specific acceptable daily exposures (ADEs) is superior to categorical designations for Quality Risk Management Programs (QRMPs).
• Toxicological and pharmacological data are essential for prioritizing compounds needing special handling.
• Controlling airborne and surface contamination based on risk assessment values prevents adverse effects.

Implications:

• Adopting ADEs and risk assessments enables more effective Quality Risk Management Programs (QRMPs) in pharmaceutical manufacturing.
• This approach enhances the prevention of cross-contamination and ensures drug product quality and safety.
• Segregation and dedication may still be necessary for specific compounds identified through rigorous risk assessment.