Pharmacy Package Producers And GMP Training
Pharmaceutical companies spend millions of pounds every year making sure that the products they research, develop and manufacture meet GMP requirements.Possible harmful interactions are reduced through testing APIs or Active Pharmaceutical Ingredients. There are also strict regulations governing the clinical trials which the medicines and devices are put through before being released for public use. These are all in the name of health and safety so that the risk these drugs pose to patients is reduced.
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. 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. For this particular area of the pharmaceutical industry, an ISO 15378:2006 would be awarded.
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.
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. 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.This is the only safeguard against drugs and medical devices from getting contaminated during packing, distribution and storage.
