Lab Qualification at major pharma site
The Quality Control department of one of our clients, active in the production of innovative biological medicines and vaccines, was looking for a reliable partner for the outsourcing of its Equipment Lifecycle Management (ELM), with a focus on Lab Equipment Qualification. In addition to the pilot project at a major Dutch site, Agidens ensured the program could be rolled out internationally.
Since many years, Agidens Life Sciences successfully provides Lab Instrument Qualification Services at several sites of our client. The Agidens consultants are no strangers to the location where we implemented the lab equipment qualification either. A team of consultants already support the Technical Operations and the Engineering Department with validation and qualification expertise.
Chris Assen, Country Manager Agidens Life Sciences in the Netherlands: “Agidens is a specialized player in a niche market. Having successfully completed projects together in the past, our customer knew what solid knowledge they were getting by partnering with Agidens.”
To work as efficient as possible and to streamline the processes, an organizational structure with a SPOC on both sides was put in place. The set-up ensures Qualification knowledge and documents are fully leveraged across the different sites.
Initial Scope Laboratory Equipment
The initial scope comprised of the introduction, replacement or decommissioning of CSV, non-CSV and calibration-only. It ranges from simple basic equipment such as plateshakers till complex qPCR systems.
Chris Assen: “I am honored that our customers are entrusting Agidens Life Sciences to execute their lab qualification activities. We’re happy to go the extra mile to ensure compliance at all stages and leverage available knowledge and documents across sites as much as possible. Our goal is to work as efficient as possible, reduce complexity and provide flexibility in order for our customers to be able to focus on their core business”
- Involvement in selection of supplier, type and design of new lab equipment and systems: manage, plan, and follow up the outsourced ELM activities:
- Set-up of qualification approach and documentation for the introduction of new lab equipment or systems, and changes to operational lab equipment or systems based on the intended use and regulatory and compliance requirements.
- Execution and follow-up of the lab equipment or systems qualification activities (IQ, OQ and PQ)
- Provide support to the technical responsible/analyst during the execution of lab equipment and systems qualification activities (OQ and PQ), including witnessing.
- Involvement in troubleshooting process for periodic testing, calibration or qualification related incidents, defects or other problems to assure the continued operation of the lab equipment and system.
- Spokesperson for qualification of lab equipment and system related topics during internal and external audits.
Supervision and first line of contact
- Coordination: administration & reporting, prioritization over the different sites and buildings of instruments qualification, progress monitoring & reporting, budget control, continuous improvement initiation and follow-up.
- Planning, resources (including scale up or scale down), quality, scope, and priorities.
- Initiation and follow-up of training of all Agidens team members in the client’s specific GMP and SHE procedures.
Johan Mathijsse, Senior Validation and Compliance Engineer & Team Lead, acts as SPOC and is responsible for the outsourcing activities. “For this pilot, we set up a team of six consultants, well balanced between junior, medior and senior engineers. Our competence in Laboratory Equipment Validation and excellent track record at other plants, open communication, teamwork, sharing knowledge across the different sites and willingness to scale up regionally and globally, contributed to a satisfied customer.”