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IS/ISO 15378 : 2017

IS/ISO 15378 : 2017 — Primary Packaging Materials for Medicinal Products — Particular Requirements for the Application of ISO 9001 : 2015, with Reference to Good Manufacturing Practice ( GMP )

IS/ISO 15378 : 2017 is an Indian Standard titled Primary Packaging Materials for Medicinal Products — Particular Requirements for the Application of ISO 9001 : 2015, with Reference to Good Manufacturing Practice ( GMP ), classified under Medical and Hospital Equipments and administered by the Ministry of Health and Family Welfare. Certification is voluntary.

IS Number
IS/ISO 15378 : 2017
Status
0
Certification
Voluntary
Ministry
Ministry of Health and Family Welfare
Committee
Hospital Equipment and Surgical Disposable Products
Type
Code of Practice

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What is IS/ISO 15378 : 2017?

IS/ISO 15378 : 2017 is an Indian Standard published by the Bureau of Indian Standards (BIS) under the title Primary Packaging Materials for Medicinal Products — Particular Requirements for the Application of ISO 9001 : 2015, with Reference to Good Manufacturing Practice ( GMP ). It falls under the <strong>Medical and Hospital Equipments</strong> group and is administered by the Ministry of Health and Family Welfare. Certification under this standard is voluntary.

How to get certified for IS/ISO 15378 : 2017

  1. 1
    Apply online — Submit the BIS portal application with product details, factory information, and test reports.
  2. 2
    Lab testing — Submit product samples to a BIS-recognised testing laboratory for evaluation against the standard.
  3. 3
    Factory inspection — A BIS officer visits your manufacturing facility to verify quality control systems.
  4. 4
    Licence grant — On approval, BIS issues the licence. You may then affix the ISI Mark on compliant products.
View official document on bis.gov.in →

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