SOP for Qualification of Facility/Equipments/Systems : Pharmaguideline

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SOP for Qualification of Facility/Equipments/Systems

Standard operating procedure to qualify the Facility, Equipments and Systems in Pharmaceuticals.


To describe the procedure for qualification of facility, equipment and system.


This SOP is applicable to the Quality Assurance department.


Officer Quality Assurance
Executive Quality Assurance


Head Quality Assurance


5.1 All the new facilities and equipment shall be qualified prior to use in production as per procedure is given below

5.1.1 Design Qualification (DQ) The first task of qualification for new facility, system and new equipment shall start with Design Qualification. The Design Qualification protocol shall prepare by the concerned department with in-corporation of supplier or vendor in accordance with user requirements. For DQ first make the necessary diagrams layouts and write down the tentative specification with the help of supplier’s specification and user requirements by considering regulatory cGMP requirements and safety requirements. The Design Qualification protocol shall be prepared for each equipment/ system/ facility based on quotation/ proposal and technical discussions between supplier and user department. Design Qualification shall be done based on the process requirements, cGMP Requirements like the material construction of product contact parts etc.., safety parameters like earthing parameters, overload settings etc. Approvals of concerned persons mentioned in protocol shall be taken and then execute the protocol. The compliance of the design with cGMP and also with the specification should be demonstrated and documented as per the general guideline mentioned in Master Qualification/Validation Protocol. Once design qualification is over, Purchase order will be released to the vendor along with the specification.

5.1.2 Installation Qualification (IQ) Installation Qualification (IQ) shall be performed on new or modified facilities, systems and equipments. IQ shall contain, but not be limited to the following points
a. Installation of equipment, piping, services and instrumentation shall check to current engineering drawings and specification.
b. Collection supplier operating and working instructions and maintenance requirements.
c. Calibration requirements.
d. Verification of construction and design criteria as applicable at this stage. The installation qualification shall certify and demonstrate eth cGMP requirement and documented, as per the guidelines mentioned in Master Qualification/Validation Protocol.

5.1.3 Operational Qualification (OQ) Operational Qualification (OQ) shall be performed after completion of Installation Qualification. OQ shall contain, but not be limited to the following points.
a. Tests that have been developed from knowledge of processes, systems and equipment and working of the subsystem.
b. Tests to include conditions encompassing upper and lower limits of operation.
c. Verification of operation criteria and specification.
d. Development of operating and cleaning SOPs, maintenance schedule and Training of operators. The successful operational qualification shall be well demonstrate and documented, as per the guidelines mentioned in Master Qualification/ Validation Protocol.

5.1.4 Performance Qualification (PQ) Performance Qualification shall follow after successful completion of Installation Qualification, Operational Qualification and after getting the clearance for Performance Qualification by Validation Team. PQ shall include, but not be limited to the following;
a. Tests, using production materials, qualified substitutes or simulated products that have been developed from knowledge of the process and the facilities, systems or equipment.
b. Tests to include a condition or set of conditions encompassing upper and lower operating limits. After successful Operational Qualification Quality Assurance Department shall prepare the Performance Qualification Protocol and perform the qualification of facilities and equipments as per approved protocol. Final release of facility / equipments will be given by Head - Quality Assurance/Site Quality Head for usage of equipments after review of Performance Qualification Report.

5.1.5 Re-Qualification Re-qualification of all critical equipment like Autoclave / Tunnel / Capsule Filling machine etc. shall be done at definite intervals as per Validation Master Plan, under defined criteria. The Criteria for re-qualification is given below;
a. Any major modification in the facility or design of equipment/system.
b. Change in the site of equipment
c. Periodic re-qualification of any equipment or system shall be done as mentioned in individual qualification protocol. The scope of re-qualification shall be decided by the validation team, depending upon the reason for re-qualification.
Related: Separate Manufacturing Facility is Required for Manufacturing of Penicillin and Non-penicillin Products


6.1 SOP - Standard Operating Procedure
6.2 DQ - Design Qualification
6.3 IQ - Installation Qualification
6.4 OQ - Operation Qualification
6.5 PQ - Performance Qualification
6.6 cGMP - Current Good Manufacturing Practice
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