The Good Manufacturing Practices, commonly known as GMP, ask drug manufacturers to prove with document the control of the critical aspects in equipment with the aim to ensure the quality of the manufactured product, the security that this product will not cause any harm to the consumer and the integrity of the critical data of the process.
At COOLVACUUM offer to our customers the qualification for freeze drying equipment service to ensure the compliance of both the requirements of the client (URS) as well as the regulatory requirements.
We take care of the elaboration of the qualification and /or validation protocols, as well as the execution of the tests included in these protocols and previously determined in the risk evaluation.
Our qualification for freeze drying equipment includes:
- Risk analisys
- Intallation qualification
- Operation qualification
- Qualificaton plan
- Incidents resolution and management
- Change control procedure implementation
Qualification process of COOLVACUUM freeze dryer