Commissioning & Qualification
The GxP guidelines require a science and risk based life cycle approach for processes, installations and instruments. In other words, an essential part of process validation is demonstrating that the systems used (technical installation, equipment, software) are under control throughout the life cycle.
Whether it is now, at the design, development and installation stage, at the time of the initial commissioning, or qualification, operational use or decommissioning, Agidens Life Sciences is always at hand to provide advice and assistance. In addition to years of practical experience, we have the best knowledge of current industry practice and the latest developments in the area of GxP.
We offer services for several commissioning processes following Good Engineering Practices:
- Commissioning and qualification plan: developing the C&K strategy to be followed, development of plan of approach, setting up methodology, including the development of ready-to-use templates
- Checklist for inspections beforehand
- Functional performance tests
- Design reports
- Training for operation and maintenance of the systems
Our documents comply with the good documentation practices making it possible to use them for qualification purposes (leveraging).
Qualification of installations and instruments
In compliance with GAMP5© and/or ASTM E2500, our validation engineers are subject matter experts in qualification and verification of the following installations and instruments:
- Utility systems
- Filling lines
- Depyrogenation tunnels
- Packing machines
- Washing machines
- Manufacturing and holding tanks
- CIP/SIP systems
- Granulation and mixing equipment
- Tableting and capsuling machines
- Packing lines
- Lab equipment
- Cleanrooms and HVAC
- Production systems such as (bio)reactors, dryers, filters, …process control systems (PLC, PCS, ..)
During operation of the installation the various processes, installations and equipment are subject to all kinds of modifications. Agidens owns the know-how required for the related quality systems and processes such as: change control, CAPA and Deviation management.
Upon retirement of a GxP installation, Agidens provides decommissioning and data migration support.
How can we help?
Is it Agidens Life Sciences you’re looking for? We’re eager to hear your questions or challenges.