Pharmaceutical Package Manufacturers And GMP Training
Pharmaceutical companies spend millions of pounds every year making sure that the products they research, develop and manufacture 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. To reach the highest quality in all aspects of their work, pharmaceutical companies and their sister businesses in the packaging industry can be awarded an ISO certificate or International Organization for Standardization.An ISO 15378:2006 would be granted as it is specific to the pharmaceutical industry.
A pharmaceutical packing company in Ireland was recently awarded the ISO certificate. Catalent’s Printed Components Plant gained the ISO certificate after a twelve month modification of its procedures. 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.
Only the packaging of pharmaceutical products is covered by the industry-specific ISO 15378 in relation to the 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.They are the only way to ensure that safer medicines are not made harmful during the distribution and storage stages.
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