Statement 3.4

Section 3

"Hospital pharmacists must ensure that an appropriate system for quality control, quality assurance and traceability is in place for pharmacy prepared and compounded medicines."

What does it mean for patients? In case of adverse events a patient has the right to receive all information necessary to check whether the event was unavoidable and not due to ineffective treatment. Thus a tracking system is necessary to assure the information flow. 

What does it mean for healthcare professionals? In case of adverse events, doctors or nurses should have the possibility to examine the manufacturing records to see whether the produced medicines fulfilled all quality requirements. This is only possible if the pharmacy implements an appropriate tracking system  

What does it mean for Hospital Pharmacists? In case of adverse events the pharmacy has to demonstrate that all quality requirements were fulfilled in the production of the medicine of interest. 

Hospital pharmacists should: 

  • Define written procedures for all 
individual preparations 

  • Record all individual 
preparations in a database 

  • Create a tracking system 


The Hospital Universitario Clinico San Carlos is SILCC Host providing training on this Statement. Please learn more about the SILCC programme here.