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ISO 15378:2017

This Customary Specifies Explicit Needs For The Appliance Of ISO 9001:2015, With Regard To Sensible Producing Follow (GMP) Needs, Applicable To Primary Packaging Materials For A High Quality Know More

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ISO 15378:2017

This customary specifies explicit needs for the appliance of ISO 9001:2015, with regard to sensible producing follow (GMP) needs, applicable to primary packaging materials for a high quality management system (QMS) wherever a corporation must demonstrate the power to produce primary packaging materials for healthful product that systematically meet client and regulative needs likewise as international best follow.

It is applicable for the planning, manufacture and provide of primary packaging materials for healthful products; the quality is generic and supposed to be applicable to any organization, despite its sort or size, or the product and services it provides.

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Steps For ISO 15378:2017

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Benefits of ISO 15378:2017

  • Ensure compliance with local legal requirements in each country
  • To give confidence to the clients that the production is carried out in accordance with the Good Manufacturing Practices
  • Ensure compliance with the principles of Goof Manufacturing Practices for primary product packaging of medicines
  • Integrate a pre-existing ISO 9001:2015 certification with a more specific sector certification
  • Adapt a focus on the continuous improvement of processes and quality
  • Implement processes aimed at supervising the quality management system