Integrating ISO quality management requirements with GMP demands on primary packaging materials for drugs: the new ISO 15378 - StevanatoGroup
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Integrating ISO quality management requirements with GMP demands on primary packaging materials for drugs: the new ISO 15378 - StevanatoGroup
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Integrating ISO quality management requirements with GMP demands on primary packaging materials for drugs: the new ISO 15378

27 / 3

2019

Our regulatory expert, Andrea Salmaso, has published an article in U&C, an Italian trade magazine specialized in technical standardization. The article, published in the February 2019 issue, takes into consideration the latest revision of the standard that involved experts from the pharmaceutical and packaging sectors to include the quality requirements of both fields: the result is ISO 15378. . Among the editors of the standard was Andrea Salmaso himself who, internationally, participated in the drafting of the latest version as Italian representative of the ISO TC76 WG6 technical commission.

The scenario that has led to the birth of this standard sees on the one hand an increasingly demanding pharmaceutical industry due to the increase in biotechnological drugs for parenteral use, and on the other the packaging producers, who are increasingly required to develop technologies for the supply of ready-to-use materials, already washed and sterilized. The packaging industry has thus become increasingly the owner of processes that were historically performed by the pharmaceutical industry, acquiring increasingly advanced skills and technologies and often preparing classified production areas. The advantages of the pharmaceutical industries in using ready-to-use materials are the reduction of the time-to-market of the drugs being registered and the costs for mass production.

Consequent to this outsourcing trend, the debate has arisen on what were the requirements of Good Manufacturing Practice (GMP) applicable to pharmaceutical packaging, as manufacturers were not normally subject to inspections by health authorities. The then ISO 9001, used as a quality standard, was in fact often not sufficient: the two types of company appeared distant even if only for the different interpretation of quality.

Published in 2006, the ISO 15378 standard introduced for the first time those quality management requirements that supplement the GMP requirements, dedicated to the development, production and control phases of medicines to guarantee their pharmaceutical quality, and ISO 9001, focused on organizational processes with the aim of obtaining products of the proper quality. The latest revision of the standard, the UNI EN ISO 15378: 2018, which constitutes the transposition into Italian of the European standard EN ISO 15378 of 2017, integrates the application of the GMP requirements during the pharmaceutical packaging production process, reducing the risk factors that can affect the quality of the finished pharmaceutical product and that can also cause mix ups. In an increasingly competitive sector such as that of pharmaceutical packaging, many benefits can be obtained from the application of UNI EN ISO 15378, given that a large chunk of recalls from the medicinal market are due to defects or packaging malfunctions due to non-compliance with GMPs.

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