ISO 15378 Standard

What is GMP?

Not every industry has the comfort of having guidelines to ensure good manufacturing practice. GMP, i.e. good manufacturing practice, is nothing else than good production practices, which, according to the principle, concern protection against contamination and provide requirements for maintaining production hygiene. For most sectors whose activities are directly or indirectly related to human health and life, there are normative requirements for good practices. In the case of direct packaging materials for medicinal products, the GMP assumptions are provided in the ISO 15378 standard.

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What does the ISO 15378:2017 standard include?

The ISO 15378 standard provides GMP principles and specifies requirements for a quality management system for direct packaging materials of medicinal products. The assumptions regarding the implementation of the quality management system result from the ISO 9001 standard. The layout of the standard is adequate to the layout of the ISO 9001:2015 standard, the content of which is quoted directly in an unchanged form and is included in frames. Additional GMP requirements and guidelines, as well as terms and definitions used, are provided below the frames.

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ISO 15378 certificate

ISO 15378 contains the requirements of the ISO 9001:2015 standard and additionally detailed requirements specified and appropriately adapted from GMP in the field of production and control of medicinal products. The introduction of the document contains information specifying that the ISO 15378 standard applies to direct packaging materials for medicinal products. GMP supplements to the requirements of the ISO 9001 standard can be found in the following points:

1. Range

among others clearly indicates the application of the standard in the processes of design, production and supply of direct packaging materials for medicinal products

2. Normative references

reference in the content to other standards is a requirement of ISO 15378

3. Terms and definitions

terms relating to organization, activity, system, requirements, process, performance, data and information, operation, specification, requirements fulfillment and risk management are defined in detail

4. Organization context

In order to meet GMP requirements, the Organization is to document the organization’s overall policy, intentions and approach to risk management, validation and change control

5. Leadership

the principles of customer orientation were specified and additional requirements regarding duties and authorizations were specified

6. Planning changes

incorporating risk management into all processes

7. Support

additional, detailed requirements are provided for the provision of infrastructure, process operating environment, staff training and supervision of documented information

8. Operational actions

additional GMP requirements are specified for sections of chapter 8 except sections 8.6 and 8.7

9. Assessment of the effects of action

the principles of analysis and evaluation as well as the issues raised during the management review were clarified

10. Improvement

for taking corrective actions, GMP provides, among others, rules for carrying out processing

In addition to the GMP requirements relating to the content of ISO 9001, the ISO 15378 standard contains annexes providing additional, very valuable information:

Annex C

GMP requirements for printed direct packaging materials

Annex D

Guidance on verification, qualification and validation requirements for direct packaging materials

All the assumptions set out in the ISO 15378 standard provide valuable guidance to ensure that the organization consistently provides direct packaging materials for medicinal products that meet customer requirements, including regulatory requirements and international standards.

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