GMP Training And Packing Pharmaceutical Medicines
GMP requirements are met by pharmaceutical companies by spending mi9llions of pounds on drug research, development and manufacture. Active Pharmaceutical Ingredients or APIs are thoroughly tested to make sure that the ingredients in the drug do not react negatively with each other. 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.
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.
A pharmaceutical packing company in Ireland was recently awarded the ISO certificate. Catalent’s Printed Components Plant undertook a twelve month development of its procedures so that they met with ISO standards. 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. The producers of primary packaging have to produce products which consistently meet customer requirements which also includes regulatory requirements and the International Standards applicable to primary 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. Medicine and devices will only stay at a high quality of the packaging is good enough through the distribution and storage phase.
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