The Integrated Quality Management System

STM PHARMA PRO S.R.L. has implemented and maintains its own “Integrated Quality Management System” to cover the following, different company management systems through a systemic approach and single documentary system:
GDP Certificate
  • Quality Management System;
  • Occupational Health and Safety Management System;
  • Privacy Management System;
  • Security Management System;
  • Business Continuity Plan and Disaster Recovery;
  • Quality Risk Management;
  • the Organizational, Management and Control Model pursuant to Italian Legislative Decree 231/2001;
  • Validation of IT Systems;
  • Qualification of IT Infrastructures;
  • Qualification of Corporate Infrastructures.
All the STM PHARMA PRO S.R.L. platforms operate to high, set standards of quality; they all have whatever ministerial and local authorisations are required for managing pharmaceuticals, narcotics, veterinary products, dietary and healthcare products in general.
The Manuals, Codes, Standard Operating Procedures and Operating Instructions, the Forms defining and structuring the “Integrated Quality Management System” of STM PHARMA PRO S.R.L. have obtained and constantly obtain extremely positive assessments by leading Italian and international Pharmaceutical Companies.
The operational logistics platforms of STM PHARMA PRO S.R.L. are ISO 9001:2008 certified and comply with a specific self-monitoring HACCP plan.
All the transport partners selected and used bySTM PHARMA PRO S.R.L. for distribution, guarantee compliance and monitoring of the product temperatures, both during any temporary transit through transit points and hubs, and during actual delivery. All the transport partners of STM PHARMA PRO S.R.L. undergo a specific qualification procedure involving periodic assessment questionnaires, onsite audits, measurement of service levels, defects and complaints.
The “Integrated Quality Management System” of STM PHARMA PRO S.R.L. is implemented on a daily basis in compliance with the industry regulations, specifically the Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01), Italian Ministerial Decree of 6 July 1999 and Title VII of Italian Legislative Decree no. 219/2006.

 

Quality Assurance Team:             
  • Luca De Toro Quality Manager
  • Marilisa Calcagno Responsible Person & Qualified Person c/o Pozzuoli
  • Beniamino Bergamaschi Responsible Person c/o Cambiago/Grezzago
  • Davide Mastroieni Responsible Person c/o Cambiago/Grezzago
  • Vincenzo Cricchio Responsible Person c/o Pozzuoli
  • Floriana Miraglia Qualified Person c/o Pozzuoli
  • Maria Rosa Leonardis Responsible Person Integrated Systems
The Integrated Quality Management System:                 
  • Manuals, Codes and Organizational, Management and Control Models.
  • Standard Operating Procedures.
  • Operating Instructions.
  • CAPA System.
  • Periodic in-house meetings.
  • Business review.
  • Management review and periodic review.
  • Internal audits.
  • Audits of Principal.
  • Audits of “Certiquality” certification body for compliance with ISO 9001:2015.

Download  ISO 9001-2015

 

 

 

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