Follow
Objective: This Standard Operating Procedure is to describe that equipment cannot randomly selected and directly put into use. It is essential to ensure suitability for performing Equipment Qualification (s) against requirement and performance capability over a period of use. Hence it is to be qualified before into use.
Scope: The scope of this Standard Operating Procedure is limited to provide a documented program which ensures that the selected equipment is evaluated, checked, reviewed, installed and operated correctly in accordance with qualified and approved plan as per manufacturer and user requirements.
Responsibility:
1. A team of experts from different disciplines such a Production, Quality Control, Quality Assurance, Validation; Engineering shall be responsible to carry out this procedure as defined.
2. Concerned Department Head, Manager Validation & Manager, Engineering shall be responsible for effective implementation of this procedure.
3. Head of Quality shall be responsible for approval of protocols for equipment qualification.
Accountability: Head of Quality
Precautions: NA
Procedure:
1. Action proving that any equipment works correctly and actually leads to the expected results.
Design Qualification (DQ): The premises, supporting utilities, the equipments, and the processes have been designed in accordance with the requirements of GMP. This constitutes Design Qualification.
Factory Acceptance Test (FAT): Testing of the equipment in the suppliers premises to make sure that the equipment have been designed and built by suppliers in compliance with the Design Qualification. This constitutes Factory Acceptance Test.
Site Acceptance Test (SAT): SAT is carried out at the site of a vendor or in-house at a specific stage prior to release of the equipment/ instrument to the next phase of the lifecycle.
Installation Qualification (IQ): The premises, supporting utilities, the equipments, and the processes have been built & installed in compliance with their Design Qualification. This constitutes Installation Qualification.
Operational Qualification (OQ): The premises, supporting utilities, the equipments operate in accordance with their design Qualification. This constitutes Operational Qualification.
Performance Qualification (PQ): The specific process will consistently produce a product meeting its predetermined specifications & quality attributes. This constitutes Performance Qualification.
2. Concerned Department Head shall do the risk assessment of the equipment before qualification.
3. DQ, FAT/SAT, IQ, OQ & PQ shall be required for new equipments. In case of any old equipment perform only IQ, OQ and then PQ as per requirement.
4. Equipment qualification shall be carried out as per approved protocol by following steps of qualifications:
Design Qualification
a. A validation team shall check the equipment as per design qualification based on user requirement specification (URS) and the requirements of process, product and cGMP.
b. As per the Design Qualification & its intended purpose the equipment shall be confirmed by engineering and respective department Head.
c. The report for the Design Qualification shall be reviewed and approved before FAT/SAT Commences.
Factory Acceptance Test
a. A validation team shall check the equipment/instrument which is already built in the manufacturer end as per design qualification based on user requirement specification (URS) and the requirements of process, product and cGMP.
b. The validation team will check the relevant documents i.e. Material of Construction (MOC), Testing certificate, Calibration certificate, Operating instruction are available at the time of FAT.
c. A validation team along with the supplier’s engineers shall run the Equipment/Instrument and checks for smooth working of machine. All operating parameters shall be checked and confirmed.
d. The validation team shall review the FAT report and approve before the shipment of Equipment/Instrument from manufacturer end.
e. Any outstanding issues will be documented in the FAT report & agreement with the supplier engineers shall be made for closing the issue either before shipment or during SAT at the site.
Installation Qualification
a. Pre-installation checks shall be carried for the Equipment/Instrument as per the requirement and Installation Qualification for functional aspects of equipment shall be performed and observations confirmed by engineering and department heads.
b. Installation Qualification for Engineering aspects like mechanical, electrical & general checks and general aspects like place of installation and equipment name, model no.,
manufacturer shall be observed and confirmed by Engineering department & Department Heads.
c. The minimum documents required at the stage of installation shall be collected from the supplier i.e. Material of Construction (MOC), Motor Test Certificate, Guarantee Certificate, Testing certificates, Calibration Certificate with operating and working instructions.
d. Passivation of product contact parts to be performed as per Passivation procedure.
e. All data /checks of Installation Qualification shall be reviewed and approved before Operational Qualification Commences.
Operation Qualification
a. Operational Qualification includes operational test data, which confirms predetermined acceptance criteria for the studies undertaken.
b. Operational Qualification shall include the details of equipment’s operation as per the design qualification or URS or considering the equipment manual.
c. A validation team shall energize the machine and run on power with simultaneous checks for proper smooth working of machine. All checks shall be checked and confirmed by Engineering & Validation team.
d. SOP for operation and cleaning of the Equipment/Instrument shall be prepared as per the operation and cleaning of equipment before the Performance Qualification.
e. Training shall be given to the concerned operators and supervisors on operation, cleaning and preventive maintenance of the equipment. All records of the same shall be documented.
f. The Operational Qualification report shall be reviewed and approved before the Performance Qualification.
Performance Qualification
a. Performance Qualification of equipment shall be carried out for the products for which Quality attributes of finished product are available which constitutes the process validation for that product and equipment gets qualified for its performance.
b. Equipment shall be operated and checked for critical parameters like mixing time, temperature, RPM etc., which have impact on product quality.
c. PQ of the equipment should be done taking data from three consecutive product batches as per PQ Protocol. Statistical analysis of the data to assess the consistency of the three product batches should be done in the PQ report. All results must be within the acceptance criteria.
d. For any inconsistency in results for the product batches, corrective action shall be taken and performance of the equipment shall be evaluated for the next three batches of the same product.
e. Based on all above results, conclusion shall be drawn. Qualification report shall be reviewed and approved for its routine use.
Re-Qualification
a. If there is any change in Machine spare part which will have impact on product quality parameters, equipment should be Re-qualified.
Equipment Qualification Review
a. The frequency of equipment qualification review report will be three years & key equipments (i.e. the equipment/s having direct impact on the product quality like Fluid bed processor, Rapid Mixing Granulator, compression machine, coating machine, blister pack machine etc. ) will be considered for qualification review.
