ISO 15378:2015 specifies necessities for a quality management system where an organization requirements to demonstrate its capacity to supply primary packaging materials for medicinal products, which constantly meet client necessities, including regulatory necessities and International Standards applicable to primary packaging materials.

Now for the big question all ISO 15378 users have: What are the changes in the ISO 15378:2015 Edition? Here’s the guidance given by the committee:

That certificate confirms that delivering products have successfully preceded a certification procedure. It means that they are high quality and meet Russian GOST-R standards. Most of the exporting products are a subject of an obligatory certification otherwise will not drive in to the boundary and will not be admitted for trade.

There are regulations identifying which products are subject to obligatory certification and which may possess voluntary certification. Certificate of conformity is essential if products or services are subject to obligatory certification according to legislation. Voluntary certification is prepared only at the initiative of the manufacturer in order to certify certain properties of the product or to persuade consumers to its high quality.

  • • This new edition includes necessities for risk management.
  • • There is an extensive revision regarding verification, qualification and validation necessities for primary packaging materials.
  • • The necessities for infrastructure, work environment, preservation and cleaning activities have been revised. Also the needs for customer communication control of production and service provision and batch release have been customized.

Benefits of ISO 15378:2015

  • • Decrease and control of risks
  • • Proof of adherence to legal needs and contractual obligations
  • • Saves time and costs
  • • Creates competitive advantages
  • • Clear statement of the organization’s competence
  • • Get better quality capability