GMP Training And Packaging Pharmaceutical Medicines
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. These are a way to limit the risk that these medical products pose to patients.
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. 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. 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.After the 12 months there was an audit which lasted 5 days and confirmed that Catalent met the ISO standards.
The ISO 15378 is industry specific and only applies to packaging for pharmaceutical products 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. Quality management Systems are regulated through the ISO 9001:2000 which is a general certificate available to organisations in any industry.
Only when all staff members are given GMP training will it be possible to achieve the highest standards of pharmaceutical packaging.They are the only way to ensure that safer medicines are not made harmful during the distribution and storage stages.
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