Pharmaceutical Packaging And GMP Training

Pharmaceutical companies spend millions of pounds every year making sure that the products they research, develop and manufacture meet GMP requirements. Active Pharmaceutical Ingredients or APIs are thoroughly tested to make sure that the ingredients in the drug do not react negatively with each other. 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. To reach the highest quality in all aspects of their work, pharmaceutical companies and their sister businesses in the packaging industry can be awarded an ISO certificate or International Organization for Standardization. A business in the pharmaceutical industry would be granted an ISO 15378:2006.

A pharmaceutical packing company in Ireland was recently awarded the ISO certificate. Catalent’s Printed Components Plant undertook a twelve month development of its procedures so that they met with ISO standards. GMP training was given to all staff members and adaptations were made to the operating procedures and quality manual to achieve ISO/GMP standard procedures. The twelve month transformation was rounded up with a 5-day audit which recognized the quality and proficiency of the plant and the auditors were happy to grant the certificate to Catalent.

The ISO 15378 is industry specific and only applies to packaging for pharmaceutical products in relation to the ISO 9001:2000. The customer requirements which factor in International and Regulatory Standards must be constantly met before a producer is granted the certificate. 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. Medicine and devices will only stay at a high quality of the packaging is good enough through the distribution and storage phase.