Pharmacy Packaging 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. 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.

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.An ISO or International Organization of Standardization certificate is one of the highest awards of packaging quality that a pharmaceutical company can achieve. For this particular area of the pharmaceutical industry, an ISO 15378:2006 would be awarded.

Recently, a packaging company in Ireland was granted the award in recognition that its packaging procedures met the quality grades and complied with GMP standards. Catalent’s Printed Components Plant gained the ISO certificate after a twelve month modification of its procedures.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.To gain the certificate a producer has to constantly meet the customer requirements which include International Standards and Regulatory requirements in terms of the quality of the 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.