Quality system

The quality system is a great strength of our company. STM PHARMA PRO has based its quality on structures that are in accordance with current regulations, the requests of regulatory bodies and the attention that our partner companies require of us.

Thanks to the authorizations issued by AIFA, the Ministry of Health, ATS/ASL and the ISO 9001: 2015 and ISO 13485: 2016 certifications, we can guarantee optimized company procedures in accordance with the cGMP/cGDP.


Our procedures include:

  • Self-inspection scheduling
  • Management of deviations and CAPA (corrective actions and preventive actions)
  • Audit to Transport, Goods and Services Partners
  • Management of customer complaints
  • Management of returned products
  • HACCP system (for food requirements, including food supplements such as supplements)
  • KPIs analysis (in this case an internal system of KPIs can easily be adapted to the KPIs requested by customers if there were specific parameters to be evaluated)
  • Temperature monitoring of our warehouses and during the transport of medicines. Following the identification of the most critical routes (worst case approach), continuous monitoring plans are established annually on temperatures during transport up to the last mile
  • Management of IT systems certified by GAMP 5, CRF 21 part 11 and Annex 11 GMP
  • Management of staff training
  • Product traceability and recall management
  • Management of company changes
  • Periodic Management Reviews
  • Risk analysis management
  • Business continuity Plan

 

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