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. All of these efforts are to reduce the risk that the drugs pose to human patients when used.

However, the packaging and distribution of the drugs and medical devices is equally important as their quality and safety can be affected during transportation and storage. An ISO or International Organization of Standardization certificate is one of the highest awards of packaging quality that a pharmaceutical company can achieve. For this particular area of the pharmaceutical industry, an ISO 15378:2006 would be awarded. 

Recently an ISO certificate was granted to a pharmaceutical packing company in Ireland and it was the first company in the country to receive one.It took twelve months of procedure development to make Catalent’s printed Components plant ready to achieve the ISO 15378. To achieve GMP/ISO standards, GMP training was given to every employee and modifications were made to the quality manual and standards operations procedures.After the 12 months there was an audit which lasted 5 days and confirmed that Catalent met the ISO standards.

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.

Only when all staff members are given GMP training will it be possible to achieve the highest standards of pharmaceutical packaging.They are the only way to ensure that safer medicines are not made harmful during the distribution and storage stages.

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