Quality - Stevanato Group
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医薬品容器は医薬品の一部であり、患者様にとって最高の品質を保証できるものである必要があります。

StevanatoGroupの使命は非経口医薬品の完全性を保証する包装資材を製造、提供し続けることです。

Stevanato Groupでは、GMP基準をベースにしたグループ全体の品質マネジメントシステムの原則一覧表を作成しました。

Stevanato Groupは常に下記を保証致します:

01

患者様の安全

02

製品適合性

03

お客様重視

04

ISO15378準拠

05

品質マネジメントシステム適合性

06

「最初から適切な方法で」

Certificates
Iso Type
Legal Entity
EZ-fillシリンジ Alba(針なし)添付文書第2版 - Nuova Ompi S.r.l. Unipersonale
EZ-fillシリンジ(針無し)添付文書第3版 - Nuova Ompi S.r.l. Unipersonale
EZ-fillシリンジ(針付き)添付文書第3版 - Nuova Ompi S.r.l. Unipersonale
ISO 9001 - Balda Medical GmbH
ISO 13485 - Balda Medical GmbH
ISO 14001 - Balda Medical GmbH
ISO 15378 - Balda Medical GmbH
ISO 45001 - Balda Medical GmbH
ISO 50001 - Balda Medical GmbH
ISO 9001 - Balda/C. Brewer
ISO 13485 - Balda/C. Brewer
ISCC PLUS - Balda Medical GmbH
ISCC PLUS - Nuova Ompi S.r.l. Unipersonale
ISO 13485 - Nuova Ompi S.r.l. Unipersonale
ISO 17665-1 - Nuova Ompi S.r.l. Unipersonale
ISO 9001 - Stevanato Group S.p.A.
ISO 9001 - Nuova Ompi S.r.l. Unipersonale
ISO 9001 - Ompi N. A. S. de R. L. de C. V.
ISO 9001 - OMPI Pharmaceutical Packing Technology (China) Co., Ltd.
ISO 9001 - OMPI DO BRASIL INDÚSTRIA E COMÉRCIO DE EMBALAGENS FARMACÊUTICAS LTDA
ISO 9001 - Medical Glass A.S.
ISO 14001 - ISO 45001 - Stevanato Group S.p.A.
ISO 14001 - ISO 45001 - Nuova Ompi S.r.l. Unipersonale
ISO 14001 - ISO 45001 - Medical Glass A.S.
ISO 14001 - ISO 45001 - Ompi N. A. S. de R. L. de C. V.
ISO 14001 - ISO 45001 - OMPI Pharmaceutical Packing Technology (China) Co., Ltd.
ISO 14001 - ISO 45001 - OMPI DO BRASIL INDÚSTRIA E COMÉRCIO DE EMBALAGENS FARMACÊUTICAS LTDA
ISO 15378 - Stevanato Group S.p.A.
ISO 15378 - Nuova Ompi S.r.l. Unipersonale
ISO 15378 - Medical Glass A.S.
ISO 15378 - Ompi N. A. S. de R. L. de C. V.
ISO 15378 - OMPI Pharmaceutical Packing Technology (China) Co., Ltd.
ISO 15378 - OMPI DO BRASIL INDÚSTRIA E COMÉRCIO DE EMBALAGENS FARMACÊUTICAS LTDA
ISO 9001 - S.P.A.M.I. S.r.l. Unipersonale
ISO 9001 - Stevanato Group Denmark A/S
ISO 9001 - EMEA TEC - Nuova Ompi S.r.l. Unipersonale
ISO 9001 - US TEC - Ompi of America Inc.
ISO 13485 - EMEA TEC - Nuova Ompi S.r.l. Unipersonale
ISO 13485 - US TEC - Ompi of America Inc.
ISO 17025 - Accredia - EMEA TEC Analytics - Nuova Ompi S.r.l. Unipersonale

CERTIFICATES

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

ISO 15378

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

n/a
n/a
n/a

ISO 13485

Medical devices - Quality management systems

n/a
n/a
n/a
n/a
n/a

ISO 9001

Quality management systems

ISO 45001

Occupational Health and Safety Management System

n/a
n/a
n/a

ISO 14001

Environmental management systems

ISO 50001

Energy management systems

local law
local law
No
No
No
No
No
n/a

17025

General requirements for the competence of testing and calibration laboratories

n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a

ISCC PLUS

International Sustainability and Carbon Certification

n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a