Current risk-based principles for shared pharmaceutical facilities, cross-contamination prevention, containment and cleaning control.
Shared facilities can be acceptable when cross-contamination risk is scientifically understood and adequately controlled. The decision should integrate toxicology, product and process knowledge rather than depend only on therapeutic class.
Cross-contamination pathways
Relevant mechanisms can include mix-up, retention, mechanical transfer and airborne transfer.
Technical controls
Facility design, closed systems, containment, HVAC, dedicated equipment parts and automated cleaning can be considered according to risk.
Organizational controls
Campaigning, cleaning verification, training, status control, material and personnel flows and deviation management can complement technical measures.
When dedication becomes necessary
Dedicated facilities or equipment may be needed when the risk cannot be adequately controlled or the toxicological assessment does not support a controllable scenario.
Frequently asked questions
Are shared facilities prohibited for all potent compounds?
No. The decision is risk-based and depends on the complete scenario.
Can cleaning alone control every risk?
No. Containment, organization and process design may also be required.
When can dedicated facilities be necessary?
When controls cannot reliably keep cross-contamination below the acceptable level or the hazard is not controllable.
Does RDC 658/2022 use a risk-based approach?
Yes. It requires QRM including toxicological and potency assessment for cross-contamination control.
