Quality - StevanatoGroup
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Quality - StevanatoGroup
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Quality

Pharmaceutical containers are integral to the pharmaceutical product itself, therefore their quality affects patient safety. Since Stevanato Group’s mission is to create systems that guarantee the integrity of parenteral medicines, ensuring maximum quality of the primary packaging is the primary goal for everyone involved in the process.

Stevanato Group has defined a list of principles as the basis of GMP (Good Manufacturing Practices), representing the quality management system orientation of the whole Group.

The aim is to always guarantee:

  • Patient safety
  • Product conformity
  • Customer-focused orientation
  • ISO15378 conformity
  • Quality Management System conformity
  • “Right first time”

CERTIFICATES

Nuova Ompi (IT-PD)
Nuova Ompi (IT-LT)
Medical Glass
Ompi of America
Ompi of China
Ompi do Brasil
Balda (DE)
Balda (US)
Spami
SG Lab

ISO 15378

Primary packaging material for medicine products - particular requirements for the application of ISO 9001:2015 with reference to Good Manufacturing Practice (GMP)

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ISO 13485

Medical devices - Quality management systems

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ISO 9001

Medical devices - Quality management systems

ISO 14001

Environmental management systems

ISO 50000

Energy management systems

local law
local law
No
No
No
No
No
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ISO 17665

Sterilization of health care products -- Moist heat

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17025

General requirements for the competence of testing and calibration laboratories

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