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Pharmaceutical Packaging Producers And GMP Training

20th November, 2009 - Posted by health news - No Comments

The research and production of medicines and devices by the pharmaceutical industry costs millions of pounds so that the products meet GMP requirements. APIs or Active Pharmaceutical Ingredients are tested for possible dangerous ingredient interaction before they are produced on a large scale.The regulations also govern the clinical trials and tests that products are put through before the public are allowed to use the drugs for medical purposes.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. Catalent’s Printed Components Plant undertook a twelve month development of its procedures so that they met with ISO standards. 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.

The ISO 15378 is industry specific and only applies to packaging for pharmaceutical products 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.The general quality management system is governed by the ISO 9001:2000 and is not industry specific.

GMP training is needed to implement proper packaging processes where medicinal products are in question.This is the only safeguard against drugs and medical devices from getting contaminated during packing, distribution and storage.