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Home  /  Computerized Systems Validation   /  ISO 15378. GMPs for manufacturers of primary medicine packages

ISO 15378: GMPs for drug packaging manufacturers

Know the ISO 15378 standard that establishes the requirements for the quality system of organizations dedicated to the manufacture of primary packaging for medicines.

ISO 15378

ISO 15378 is the standard of ISO – International Organization for Standardization – that offers a set of Good Manufacturing Practices or GMP for the manufacturers of primary packaging of medicines. It also provides the requirements for these organizations to comply with international quality standards.

The control of the quality of the primary packaging material is of vital importance for the safety of people who use a medicine since said material is in direct contact with the product.

Therefore, implementing a management system that incorporates its requirements and certifies in ISO 15378 implies numerous benefits for companies and patients. Next, we deal in greater detail with this standard, the benefits that its implementation can provide and how to deal with the certification process.

What is ISO 15378?

ISO 15378 was published in 2006 for the first time, developed in collaboration with expert professionals from the pharmaceutical industry. To facilitate the processes, the quality requirements of the ISO 9001 standard are incorporated in a single document together with the Good Manufacturing Practices or GMP.

In this way, the standard includes in a single document the requirements for the quality management system and the guidelines to follow to comply with the GMP for companies that manufacture primary packaging of medicines.

In its most recent revision published in 2017, ISO 15378 makes use of the same high-level structure, usual in the latest revisions of standards such as ISO 9001, ISO 14001 and ISO 45001.

And in addition, the GMP requirements, which include lot tracking, validation, and controlled environment, risk management, etc.

The certification of the ISO 15378: 2017 standard contributes to improving the qualification of the organization before the companies of the pharmaceutical sector to which it provides. The standard is valid for all manufacturers of containers and packaging intended for medicines, regardless of whether the manufacturing material is glass, metal, cardboard, rubber or plastic. And its certification is accepted anywhere in the world.

Benefits of ISO 15378

The ISO 15378:2017 certification provides a guide to implementing risk management and validation in the sector and helps organizations to:

  • 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.
  • Integrate a pre-existing ISO 9001:2015 certification with a more specific sector certification.
  • Ensure compliance with the principles of Goof Manufacturing Practices for primary product packaging of medicines.
  • Identify, evaluate and mitigate or eliminate risks, among which are pollution and errors in manufacturing.
  • Optimize internal processes and productivity and profitability of operations.
  • Implement processes aimed at supervising the quality management system.
  • Adapt a focus on the continuous improvement of processes and quality.

For all the above, the ISO 15378 certification makes the company that obtains it can market its products more easily. It is even possible that it will help you access international markets successfully.

How to obtain certification in ISO 15378:2017?

ISO does not certify ISO 15378, but it does allow an independent certifying body, endorsed by ISO, to do so. Having the ISO 9001 certification previously can facilitate the certification process, which in any case requires following these steps:

  • First of all, you have to know the norm. Obtaining a copy of the standard and reading it carefully is the beginning of the road to certification.
  • Based on the reading of the text of the standard, it is advisable to prepare a checklist of the requirements. It is also interesting to perform a gap analysis to establish to what extent the organization currently meets the requirements of the standard.
  • As determined by the gap analysis, the necessary actions must be implemented to achieve compliance with the requirements of ISO 15378
  • In addition, an internal audit must be scheduled and carried out to verify full compliance with the standard.
  • In case of finding any type of inconsistency, non-compliance or nonconformity, the corresponding corrective measures must be implemented.
  • Consequently, the corrective measures implemented must be followed up to verify their effectiveness.
  • Finally, we must choose a certification body endorsed by ISO and request an external certification audit.

At Oqotech we have more than a decade helping companies that work in regulatory sectors to optimize their processes and ensure regulatory compliance.

Contact one of our consultants and get the advice you need to implement and certify ISO 15378.

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