Installation Qualification definition

Installation Qualification provides verification and documentation that the equipment is properly installed at the Property, that the materials of construction meet cGMP requirements and that the equipment is properly connected to utilities and controls according to the vender and engineer specifications.

Installation Qualification has the meaning specified in Annex 15 to the EU Guide to Good Manufacturing Practice (EUDRALEX Volume 4).

Installation Qualification means the program employed by I3 by which it is established that the equipment and systems used in the Process are capable of consistently operating within established limits and tolerance for purposes of Processing the Product for use in Clinical Trials.

Examples of Installation Qualification in a sentence

• The descriptions of these services are listed below: • Installation Qualification: documentation that facilities in which the instrument has been installed are in accordance with requirements and safety regulations of the original manufacturer.

• Qualification: User Requirement Specification, Design Qualification, Factory Acceptance Test (FAT)/ Site Acceptance Test (SAT), Installation Qualification, Operational Qualification, Performance Qualification, Re- Qualification (Maintaining status- Calibration Preventive Maintenance, Change management), Qualification of Manufacturing Equipments, Qualification of Analytical Instruments and Laboratory equipments.

• Installation Qualification, Operational Qualification and Instrument Performance Verification are available upon the Customer’s request at any time during the term of the Agreement.

• The Installation Qualification of contract work shall verify systems are correctly and properly installed.

• UNIT - IIQualification: User Requirement Specification, Design Qualification, Factory Acceptance Test (FAT)/ Site Acceptance Test (SAT), Installation Qualification, Operational Qualification, Performance Qualification, Re- Qualification (Maintaining status-Calibration Preventive Maintenance, Change management),Qualification of Manufacturing Equipments, Qualification of Analytical Instruments and Laboratory equipments.

More Definitions of Installation Qualification

Installation Qualification means a process of obtaining and documenting evidence that equipment has been provided and installed in accordance with its specification;

Installation Qualification means the documented qualification, based on objective evidence provided by CIPAN to Paratek in either written or oral form, that the installation of process equipment and ancillary systems has been completed in accordance with the manufacturer’s approved specifications and any

Installation Qualification means the program employed by Nordion by which it is established that the process equipment in question and ancillary systems are capable of consistently operating within established limits and tolerances.

Installation Qualification will mean the documented verification (i.e., supporting documentation must be in place and of suitable quality) that all aspects of the Facility excluding Punch Lists Items (including, without limitation, the Utilities and the Equipment) that can affect achievement of Operation Qualification, Performance Qualification and Process Validation are installed correctly and in accordance with design documentation requirements (including, without limitation, specifications, purchase orders, contracts, and bid packages).

Installation Qualification means the verification that equipment being qualified has been installed and configured according to the manufacturer’s specifications or installation checklist.

Installation Qualification means the documented qualification, based on objective evidence provided by CIPAN to Paratek in either written or oral form, that the installation of process equipment and ancillary systems has been completed in accordance with the manufacturer’s approved specifications and any recommendations provided by the supplier of the equipment with respect to such installation (or, if any such recommendation has not been adopted, CIPAN shall provide objective evidence of their good faith consideration to such recommendation). CIPAN shall provide written evidence to Paratek that the equipment and its ancillary systems or sub-systems have been installed in accordance with installation drawings or specifications established by the Parties for the New Facility Area. For the avoidance of doubt, [***].

Installation Qualification means the documented verification required to comply with cGMP Requirements that all key aspects of the installation of the equipment and ancillary systems used or to be used in the Manufacturing Process adhere to the approved designs and the recommendations of the manufacturer;