Getting to grips with GAMP
When your medical tubing products are helping to save lives around the world, staying on top of current issues is essential. A customized training course has strengthened Optinova's knowledge of GAMP, and provided a starting point for developing new quality processes.
The Åland archipelago consists of some 6,500 islands between Finland and Sweden. Today, it is an autonomous territory that belongs to Finland, but speaks Swedish and has its own flag. Åland's rich history has taught the inhabitants the ability to adapt in the face of change. Optinova, located just outside of Åland's capital Mariehamn, has been doing just that for 40 years.
Optinova has developed a global reputation for fulfilling customer expectations through precision extrusion of tubing for medical applications. The company's components are incorporated into lifesaving products around the world, including IV catheters and a variety of cardiovascular devices. Production processes have been fully validated and manufacturing is carried out according to cGMP guidelines.
“The course proved very successful. It provided the grounding we needed and gave us a very good starting point for developing our own systems.”
Dan-Ola Westerlund, Optinova
More recently however, the increasing role of software supporting operations prompted the company to widen its quality management approach. But since Optinova did not have any experience regarding the validation of computerized systems, it needed to bring in somebody that did.
A DAY IN THE LIFE OF GAMP
That person was a senior consultant from PlantVision with more than 12 years' experience of quality assurance and computerized system validation within the life science industry. As with all PlantVision's training opportunities the course content was customized to the customer's needs.
A full day training course was held at Optinova's offices. Holding the course onsite allowed a wider group of employees to attend. This was particularly useful since the quality, IT, production, development, and administration departments all work with different programs that have, or potentially have, an impact on the production process.
With participants having little or no previous experience in this area, the introductory course provided both a theoretical and practical approach to the validation of computerized systems according to Good Automated Manufacturing Practice guidelines, version 5 (GAMP5).
A practical exercise based on one of Optinova’s own systems allowed participants to work through the validation process using a relevant, real life example.
An important part of the course was the practical exercise based on one of Optinova's own systems. This allowed participants to work through the validation process using a relevant, real life example.
FROM THEORY TO REALITY
Dan-Ola Westerlund, the course organizer at Optinova, says the course has had a positive impact on the company. "Considering our initial position and the varied backgrounds of the attendees, the course proved very successful. It provided the grounding we needed and gave us a very good starting point for developing our own systems."
The first of these systems, covering general instructions for implementing change, is now almost in place. The next step for the company will be a system for the auditing of suppliers. "I would not hesitate to recommend this type of training course for other companies in a similar position," says Dan-Ola.
Nobody can escape the need for change. It is how we embrace change that defines us. And when it comes to keeping up to date with changing guidelines and regulations, you can be sure that PlantVision will be able to embrace your needs.