Adherence to the cGMP Guidance
Specification, Documentation & Acceptance Testing
In general, Tuttnauer adheres to the cGMP in order to satisfy your requirements for documentation and qualification of pharmaceutical autoclaves.
In order to give our customers the confidence that they are using safe high quality cGMP pharmaceutical autoclaves, Tuttnauer comprehensively documents the design specifications, components, software, manufacturing process, and acceptance testing in order to prove that the autoclaves meet the customer’s requirements.
GAMP
In order to ensure quality manufacturing, Tuttnauer applies GAMP guidelines at various stages of the manufacturing process.
Acceptance Testing
Tuttnauer has an advanced testing laboratory for acceptance testing of each autoclave before it leaves the factory. Each autoclave is subjected to Factory Acceptance Testing (FAT) which includes IQ - OQ documentation. In order to facilitate site validation, Tuttnauer provides a Site Acceptance Testing (SAT) service which includes IQ - OQ documentation.
Deliverable Documentation
Depending on customers requirements the following documentation can be supplied:
- DQ, IQ, OQ (including document templates for SAT)
- List of materials and components (with ID tagging)
- Data sheets and certificates for components and subsystems
- Certification of calibration
- Conformity certification
- Dimensions and location drawings
- Installation instructions
- Operations/technical manual
Standards and Directives
Control & Documentation
Features and Options
Standard ✓ Optional o
| Validation and Support Documentation | |
| IQ/OQ Documentation (cGMP) | ✓ |
|
DQ Documentation
|
o |
| Software Sequence of Operation (SOO) | o |
| FAT (Pre-qualification) | o |
| SAT (IQ/OQ) | o |
| Control | |
|
21 CFR part 11
|
✓ |
|
SCADA
|
o |
| Independent Recorder | o |
| 10” Touch Screen (7” standard) | o |
| External Printer | o |