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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 a way to limit the risk that these medical products pose to patients.

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. A business in the pharmaceutical industry would be granted an ISO 15378:2006.

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.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. 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. 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.

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.

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