IS ISO 15378:2017 PRIMARY PACKAGING MANAGEMENT SYSTEM
ISO 15378:2017 outlines the criteria for a quality management system (QMS) for
the production of primary
packaging for medicinal goods.
Its purpose is to guarantee that the packaging
materials employed in the pharmaceutical sector adhere to the
utmost levels of quality, safety, and functionality.
This standard is crafted to assist pharmaceutical firms in adhering to
legal mandates, like Good Manufacturing Practice (GMP) for packaging substances, by offering a structure for the creation of a QMS that is subject
to audits and certification.
The ISO 15378:2017 Standard offers strategic resources that lower expenses by reducing waste and
errors in production, while boosting efficiency. It motivates companies to explore new markets and promotes fair and affordable global trade. By
adhering to GMP standards set by the ISO 15378:2017 certification, manufacturers can enhance their
skills in production processes.
This standard helps to mitigate risks related to product contamination, mix-ups, and mistakes, ensuring the product's effectiveness and longevity. It guarantees the quality of products to customers, leading to increased
customer satisfaction. This standard gives companies a competitive edge over competitors who are not certified. Implementing risk management strategies aids in minimizing
mistakes related to the product.
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