Equipment,Instrument and System qualification procedure

Equipment/System Qualification:Studies, which establish with confidence that the process equipment and ancillary systems are capable of consistently operating within established limits and tolerances. The studies must include equipment specifications, installation qualification, and operational qualification of all major equipment to be used in the manufacture of commercial scale batches. Equipment Qualification should simulate actual production conditions, including "worst case"/ stressed conditions.

   The qualification activities will be completed within following stages

1. User Requirement Specification(URS): A specification that describes the requirements of the user in details. It is prepared by concern user department  with actual requirement, operation to be performed, stage at which the equipment is required and cGMP requirement. this section shall be evaluated and approved by user, technical and quality unit jointly.
2. Design qualification(DQ)  : The first task of qualification for new equipment/systems shall start with the design qualification. Design qualification shall be provided by the supplier or vendor and shall be approved by the site in accordance with the user requirement specifications. design qualification shall be provided by vendor or prepared by in-house by technical departments.
3. Factory acceptance test: After fabrication of machine ,it is tested at site before dispatch / shipping of machine. 
4. Installation Qualification(IQ): The performance and documentation of tests to ensure that equipment (such as machines, measuring equipment) used in a manufacturing process, are appropriately selected, correctly installed and work in accordance with established specifications.
   Installation Qualification shall be carried out as per the installation qualification protocol, which shall be made in-house. However, Installation/Operational qualification may be carried out with manufacturer/supplier qualification protocol also. following points to be consider but not limited to...
   
   
   • Identification of major components.
   • Identification of supporting utilities.
   • Identification of safety measures.
   • Identification of Standard Operating Procedures.
   • Identification of component to be calibrated.  
   • Verification of drawing and documents. 
   •  Verification of Material of Construction. 
     
   
   
   Installation qualification protocols shall be prepared for each equipment and systems Supplier Qualification (Installation, operation & performance protocols) documents for equipment's / instruments shall be accepted, if meet the qualification approach defined in VMP and protocols and shall be approved by the quality assurance departments before and after execution.
   If the supplier documents does not contain the contents as defined in the VMP and Protocols the in-house protocols for the same shall be prepared and executed and all the supplier supporting documents and test certificates shall be reviewed and signed and attached with the respective protocols.
     
   
5.   Operational Qualification(OQ): Documented verification that the system or sub-system performs as intended throughout all anticipated operating ranges. Operational qualification shall be performed after the completion of the installation qualification, the following points shall be checked during operational qualification but not limited to:
   • Verification of functional checks.
   • Verification of key functionality of control panel.
   • Verification of safety and interlocking measures.
   • Verification of SOPs.
   • Training for operating personnel.
   • Verification of calibration of measuring devices.
6. Performance Qualification (PQ): Documented verification that all aspects of a facility, utility or equipment that can affect product quality performs as intended meeting  perform as intended meeting predetermined specification,after completion of operational qualification performance qualification shall be started with following consideration
   
   
   • To establish maximum and minimum capacity/operating range of equipment.
   • To establish, check and document the performance of the equipment/system in the       predetermined specification.
   
   
7. Re-qualification (RQ): Qualification of a previously validated equipment,instrument and system that has been changed or modified. Re-qualification can be performed as the result of the change to the system, or a time based assessment. Re-qualification shall be done as per following ...

•  Periodic re-qualification : on the basis in house /guidance frequencies establishment 
• After major changes, modification , relocation of system,equipment and instruments.