GEA Lyophil complies with GAMP guidelines
All our freeze drying projects will be handled strictly
according to GAMP as most widely used and internationally accepted validation
guideline within the pharmaceutical industry.
Project organization in accordance
with GAMP
In order to comply with GAMP
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