LB Series, Bin washer equipement
Inspection, testing, documentation and training
We believe on the importance to show and to demonstrate that all the steps of the manufacturing processes, starting from the specifications and the component selection up to the assembly and factory testing are made in accordance with the customer specifications and performance requirements. ICOS PHARMA can furthermore demonstrate and document that our quality control program strictly follows the Good Engineering Practice. ICOS PHARMA follows the ISPE's GAMP guidelines to respect the project execution and the supplying of the documentation to support the customer's qualifications.
Comprehensive validation support documentation
» To ensure compliance with specifications and documentation is maintained, in-process checking is performed during the manufacturing process.
» A FAT (Factory Acceptance Test) is made on each unit and a complete set of documentation is supplied to the customer together with installation, user and instruction manual when the machine is delivered.
» On request Pre-Qualification of the system can be supplied: this will carry out the same test procedures as defined in the IQ-OQ protocols to be later performed on site as part of the validation process. This procedure will help the start up of the machine pointing out any minor issue with the equipment and the documentation and precede the site acceptance testing which will be performed later on.
Compliance and guidelines:
The planning and the production of our washing and drying systems is based on standards and guidelines recognized both worldwide as well as in the final installation country: GAMP - cGMP - A.S.M.E. - MCA - ISPE baseline - FDA - 21CFR part 11 - ISO 9001.