Selecting the right quality partner
The introduction of GAMP5 meant Octapharma needed to review its systems and routines for its blood plasma production. By choosing the right partner it has achieved this and, at the same time, developed shorter and clearer QA and validation instructions.
A new version of GAMP (Good Automated Manufacturing Practice) was released in spring 2008, GAMP5. The purpose of the guide is to help companies effectively comply with regulations concerning development, implementation and management of computerized systems. GAMP5 emphasizes that qualifying activities should be based on risk assessment and should cover the entire life cycle of a system.
"We wanted help to interpret and implement GAMP5 with regard to our systems and procedures," says Jenny Josefsson, IT Manager at Octapharma.
Octapharma produces blood plasma for an international market. Operations are highly regulated, including the need to meet strict requirements for quality assurance and traceability, as set out by the American Food and Drug Administration (FDA).
"Validera's consultants are very experienced and work in a highly structured way. They are responsive and have helped us to move forward in a very good way."
Jenny Josefsson, IT Manager Octapharma
Octapharma invited several different consultants to discuss the assignment. After these interviews Validera stood out as the best alternative. "Quite simply, we received the best answers from Validera's consultants. They also provided suggestions for the best approach."
Looking back, Jenny Josefsson is very happy with the choice of consultant. "Validera worked in a highly structured way to achieve simplification and to create a common approach for the entire validation life cycle. We received the help we needed to move forwards with the problems we had previously."
"Above all, I am very pleased with Validera's ability to listen to our needs and then work independently to develop suitable solutions."
Initially, Validera were part of the working group to develop general instructions for working with validation and qualification. This resulted in shorter and clearer instructions.
While this work was ongoing, Octapharma was notified of an FDA inspection. Validera was commissioned to support a periodic review of some of the company's key systems and to complete the instructions that were missing according to the life cycle model contained in GAMP5.
"We feel we have benefited greatly from Validera's input. Above all, I am very pleased with Validera's ability to listen to our needs and then work independently to develop suitable solutions."
The pharmaceutical company Octapharma is a leading player on the international plasma market with production facilities in Sweden, Austria, France, Germany and Mexico. It carries out its own research and development at various sites, including in Sweden. The company's head office is located at Lachen, Switzerland. The number of employees is approximately 1,800. In 2007, sales amounted to more than SEK 7.1 billion.