The industrial sector of the production of pharmaceutical and cosmetic products are the most demanding in terms of requirements for documentation of the quality of used equipment. Our goal in Inox Style is not the mere supply of production equipment and the provision of all these supporting services that ensure and document the quality of the supplied equipment.
Continuous updating and training Qualification and Documentation issues is one of our top goals.
We plan and work in full compliance with the latest industry standards related to the Pharmaceutical and Cosmetics industry.
The training of our services based on Guidelines:
- ISPE Guidelines.
- EU-GMP Guidelines.
- FDA Inspection Guides.
Technical Documentation
Each machine on delivery is accompanied by a complete technical dossier including the documentation required by the relevant European Directive (CE) for machinery.
- Mechanical / Electrical / Pneumatic drawings of construction.
- P&IDs.
- Instructions & Maintenance.
- Parts list.
- Components Documentation.
- Instruments Documentation.
- Valves Documentation.
IQ/OQ Protocols
The Validation of pharmaceutical systems requires careful verification of functional specification and design to ensure that the final product meets the original specifications and regulations.
The cost of non – quality products always proves too high for this purpose drawn up in cooperation with our customers Protocols Installation Qualification (IQ) and Operation Qualification (OQ) to predict possible failures and ensure production processes.
Installation Qualification (IQ):
The documented verification system design is achieved by controlling the equipment constructed in relation to the design specifications. Our protocols provide lists easily understood and can be completed as easily and quickly.
Operation Qualification (OQ):
The documented verification of functional design is achieved by controlling operating data relative to operation specifications were originally set. The OQ protocols are designed for easy recording of critical parameters and provide efficient validation (Validation) equipment.
Εκπαίδευση Τελικού Χρήστη
We provide the necessary training to the end user on the operation and maintenance of Inox Style machinery and equipment. Qualified personnel care when starting the equipment to be fully understood by the operators how the equipment works properly and that should be the work efficiently and safely.
