PHARMAPAC awarded the ISO 13485:2016 Medical Device Quality Management System certification by BSI
PharmaPac has today announced that they have successfully completed the transition audit to the ISO 13485:2016 medical devices Quality Management System (QMS).
To qualify for the certification, PharmaPac has shown BSI auditors that their infrastructure, quality processes and systems comply with the revised quality management system standard. The rigorous 2 day inspection covered all aspects of the PharmaPac business, operations and quality systems.
The contract manufacturer has always regarded quality and compliance as paramount and the upgrade of this standard from their previous ISO 13485:2012 certification gives further assurance to customers that PharmaPac has the quality assurance systems, experience and trading record to supply superior products in an increasingly regulated environment.
By implementing ISO 13485:2016 PharmaPac will continue to build on its existing knowledge to support customers in the various key stages when launching new medical devices in both the Pharmaceutical and Vaping Industries, therefore specifically enabling PharmaPac to: –
- Manufacturer, fill and pack safe and effective medical devices
- Find ways to increase efficiency and cost savings through quality management for product conceptualisation, pilot production and commercialisation of a medical device
- Better meet customer and regulatory requirements leading to increased patient safety
- Monitor supply chains to achieve continuous improvement
Linda McEnaney, PharmaPac’s Quality & Compliance Director, commented “We are very proud to have been successful in our transition to this revised standard which represents the culmination of a significant amount of hard work. This enables us to provide our clients with the best service possible and other partners to develop and commercialise medical devices from concept to the consumers both in the UK and worldwide”.
John Pugh, PharmaPac’s Chief Executive Officer, added “ISO 13485 is the world’s leading medical device standard – therefore this endorsement from the BSI gives assurance to customers that we are able not only to support them with their medical devices, but that we apply the same level of integrity and consistency when contract manufacturing other high-quality products for the vaping industry such as PODs, bottles, gums, closed devices and next-generation products; essential for compliance in a globally regulated environment.”
- PHARMAPAC is located in modern cGMP compliant production and storage facility located on a secure business park in Birkenhead, Liverpool (North West of England) (100,000 sq ft across 10 units) with over 300 GMP trained operatives (working 24/7).
- PHARMAPAC VENTURES is the sales and marketing division within PHARMAPAC which has held an MHRA licence for 20 years; a GMP approved for UK, Europe and International markets; a Home Office Controlled Drugs Licence and is FDA Site registered.
- PHARMAPAC VENTURES offers the manufacture, filling and packing of nicotine products for the vaping, NRT, and novel nicotine delivery technology industries use their innovation to partner with companies looking to grow their brands across the globe.