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ISO 15378

Primary Packaging Materials for Medicinal Products


ISO 15378

Requirements for applying 9001:2015 standard, referring to good manufacturing practices.

ISO 15378 is a standard for designing, producing and supplying primary pae ckaging for medicine which specifies the requirements of good manufacturing practices applicable to a quality management system (based on ISO 9001); used when an organization wants to demonstrate their capacity to provide primary packaging materials for medicine that satisfy customer’s requirements, besides regulated requirements and international applicable standards.

The standard incorporates standards guidelines for the main manufacturer of glass, plastic, rubber, aluminum, and other used materials to for medicine packaging, besides the identification, reduction and risk control, including contamination and manufacturing mistakes.



ISO 15378 requirements are established from the following sections:

1. Organization context

2. Leadership

3. Planning

4. Support

5. Operation (additional requirements related with BPM)

6. Performance evaluation

7. Improvement



  • Recommendations:
  • To keep internal auditors with the competence to perform internal audits.
  • To keep records related with at least to one internal audit.
  • To keep evidence of implementation related to the documented process, records control, taken actions, internal audits and among others.
  • To keep records related to management commitment where the compliance of requirements is assured marked in ISO 15378.
  • To keep policies and defined objectives related and recorded in agreement with the standard requirements.


Audit under Global Standards methodology


ISO 15378 requirements are established from the following sections:

Improving the organization image to create trust among customers and consumers.

The BPM application in pharmaceutical packaging materials helps to comply with the necessities and requirements of the pharmaceutical industry.

A higher level of structure which allows the integration of other ISO management systems and Improving operations efficiency and profitability of operations.

Improvement of the efficiency and profitability of operations.


Process to obtain an international certificate with Global Standards 

The certification process pays attention to every detail to make sure that the company duly complies with all of the standard’s requirements.


Quote and signing of the contract


Planning and Development of Audit


Closing of Non-Conformities


Certification Committee and Issuance of the Certificate

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