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GMP Training And The Packaging Of Pharmaceutical Products

The research and production of medicines and devices by the pharmaceutical industry costs millions of pounds so that the products meet GMP requirements.Possible harmful interactions are reduced through testing APIs or Active Pharmaceutical Ingredients. There are also laws on the way that clinical trials are carried out.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. 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 an ISO certificate was granted to a pharmaceutical packing company in Ireland and it was the first company in the country to receive one. 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. 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. ISO 9001focuses on quality management systems that should be implemented in all organizations no matter what their industry, so they are not specific to the pharmaceutical industry.

Only when all staff members are given GMP training will it be possible to achieve the highest standards of pharmaceutical packaging.This is the only safeguard against drugs and medical devices from getting contaminated during packing, distribution and storage.