GEA Lyophil complies with GAMP4 guidelines
All our freeze drying projects will be handled strictly according to GAMP4 as most widely used and internationally accepted validation guideline within the pharmaceutical industry.
Project organization in accordance with GAMP4
In order to comply with GAMP4 guidelines, GEA Lyophil has developed organisational instruments within the project management that support validation and qualification activities. For example the customer’s URS (User Requirement Specification) will be evaluated and all GMP relevant requirements will be documented. A traceability matrix will be drawn up and followed up during the course of the freeze drying project, assuring a complete tracing back of the customer’s requirements and their fulfilment from the start of the project until the final SAT.
Do you want to know more about the GEA Lyophil way of project organization? Please use the contact box to the right.
Risk Analysis
A pharmaceutical company has to make a risk analysis when purchasing a new freeze dryer. This can be done by the customer alone, but GEA Lyophil offers support in this task, as we have in many projects made the experience, that close cooperation helps all project members - from GEA Lyophil's and the customer’s side –gain a deeper insight into the project process. This enables the project team to trace all activities from risk detection to the end of the validation. The testing and the documentation can be limited to previously defined objects, giving clear guidance and avoiding unnecessary activities and “dead paper”.
Installation and Operation Qualification Approach for Freeze Dryer and SCADA System
The Design Qualification will be carried out as joint activity of GEA Lyophil and the customer. As option GEA Lyophil offers support for the Installation and the Operation Qualification (IQ/OQ) which has several benefits:
• Deep knowledge of the system
• Deep knowledge of validation of the equipment with different customers
• Combination between commissioning and qualification activities can reduce lead time
• Just in time correction of findings possible (under change control)
Documentation
Experience shows, that well prepared documents shorten the validation time and simplify the validation process. For this reason, GEA Lyophil has developed tests and the corresponding documentation that can streamline your validation process.
- General Documentation:
Operating Instructions, Functional Specification, Safety Instructions
- Operator Manuals
Mechanical Documentation:
Instrumentation list, Component list, Maintenance plan, P&ID, Pressure vessel code certificates (This applies only for steam sterilizable units), Welding documentation with isometric drawings (option), Material certificates (option)
- Calibration Documentation
- Electrical Documentation
Hardware and Software Design Specification, Wiring diagram, list of input and output
- PC Documentation
Installation software, disaster recovery
- PLC Documentation
- Process Documentation
PIN charts, list of failure messages