The research and production of medicines and devices by the pharmaceutical industry costs millions of pounds so that the products meet GMP requirements. APIs or Active Pharmaceutical Ingredients are tested for possible dangerous ingredient interaction before they are produced on a large scale. There are also laws on the way that clinical trials are carried out. These are all in the name of health and safety so that the risk these drugs pose to patients is reduced.

But manufacturers also need to remember that the packaging of medicines and devices is just as important because this can affect the quality of the drugs during travel, storage and their shelf life. When your packaging system is top quality and in line with GMP regulations a pharmaceutical company can be awarded a certificate by the International Organization of Standardization or ISO.An ISO 15378:2006 would be granted as it is specific to the pharmaceutical industry.

A pharmaceutical packing company in Ireland was recently awarded the ISO certificate.It took twelve months of procedure development to make Catalent’s printed Components plant ready to achieve the ISO 15378. The quality manual and standard operating procedures were rewritten and implemented whilst all staff members were given GMP training on the new procedures. It was confirmed that Catalent met GMP/ISO standards after a 5 day audit which assessed their whole production line.

The ISO 15378 is industry specific and only applies to packaging for pharmaceutical products in relation to the ISO 9001:2000.To gain the certificate a producer has to constantly meet the customer requirements which include International Standards and Regulatory requirements in terms of the quality of the packaging materials. Quality management Systems are regulated through the ISO 9001:2000 which is a general certificate available to organisations in any industry.

GMP training is needed to implement proper packaging processes where medicinal products are in question. They are the only way to ensure that safer medicines are not made harmful during the distribution and storage stages.

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