Pharmaceutical companies spend millions of pounds every year making sure that the products they research, develop and manufacture meet GMP requirements.Possible harmful interactions are reduced through testing APIs or Active Pharmaceutical Ingredients. There are also strict regulations governing the clinical trials which the medicines and devices are put through before being released for public use. These are all in the name of health and safety so that the risk these drugs pose to patients is reduced.

But equally important in the safety of drugs is the way that they are packaged as this affects their safety during transportation and storage as well as 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. For this particular area of the pharmaceutical industry, an ISO 15378:2006 would be awarded.

Recently, a packaging company in Ireland was granted the award in recognition that its packaging procedures met the quality grades and complied with GMP standards.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.

Only the packaging of pharmaceutical products is covered by the industry-specific ISO 15378 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.

When medicinal products are being packaged, employees need to have received GMP training so that they know their actions are in line with the regulations.This is the only safeguard against drugs and medical devices from getting contaminated during packing, distribution and storage.