GMP requirements are met by pharmaceutical companies by spending mi9llions of pounds on drug research, development and manufacture. 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. 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.An ISO or International Organization of Standardization certificate is one of the highest awards of packaging quality that a pharmaceutical company can achieve. A business in the pharmaceutical industry would be granted an ISO 15378:2006.
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. It was confirmed that Catalent met GMP/ISO standards after a 5 day audit which assessed their whole production line.
The ISO 15378 is very specific to the primary packaging materials of medicinal products in relation to the application of 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. 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.
GMP training is needed to implement proper packaging processes where medicinal products are in question.They are the only way to ensure that safer medicines are not made harmful during the distribution and storage stages.
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