Fill & Finish
Our services include: - Formulation
- Sterile filtration
- Aseptic filling
- Freeze-drying
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in a class A (100) with B (1000) background area by trained and validated personnel and process.
We seemlessly takes cGMP manufactured material on for formulation and F&F, in preparation for your clinical trials, using the expertise of long term preferred partners.
The Fill and Finish work is conducted under the Current Pharmaceutical Guidelines and the finished product is an injectable for human clinical trials.
All work associated with the Fill and Finish process conducted at the partner's site is controled by Eurogentec's Qualified Person (QP). The QP will review each manufacturing batch record for compliance with approved Process Documents.
We undertake the following:
Area | Event | Eurogentec | Partner |
Initiate | Inspect facilities | √ | |
Raw materials | QC and release | √ | |
Manufacture | Preparation of clinical batch |
| √
|
| Sampling of Clinical Batch | √ | √ |
| Perform in process testing (IPC) |
| √ |
Quality assurance | Environmental testing |
| √
|
| File batch record | | √ |
Release | Review and release batch record | √ | √
|
| Release / reject batch | √ | |
| Maintain reject records | √ | √ |
| Store released finished product | √ | |
Quality Control | Operate bioburden programme for facilities and equipment | | √ |
| Perform release testing on finished product | √ | |