GMP Training And Packaging Pharmaceutical Devices
The research and production of medicines and devices by the pharmaceutical industry costs millions of pounds so that the products meet GMP requirements. Active Pharmaceutical Ingredients or APIs are thoroughly tested to make sure that the ingredients in the drug do not react negatively with each other.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 a way to limit the risk that these medical products pose to patients.
But manufacturers also need to remember that the packaging of medicines and devices is just as important because this can affect the quality of the drugs during travel, storage and 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.GMP training was given to all staff members and adaptations were made to the operating procedures and quality manual to achieve ISO/GMP standard 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. 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.This is the only safeguard against drugs and medical devices from getting contaminated during packing, distribution and storage.
