SOP for Equipments and Machines Qualification

PURPOSE

To provide the guidelines for qualification of equipment, and system to verify that the equipment, and system has been designed, installed, operated, and performed as per user requirement by cGMP guidelines defined by various regulatory bodies.

SCOPE

The scope of the SOP covers the validation, preparation & approval of Protocols.

RESPONSIBILITY

The validation team comprises of representatives from the Functional Department, Engineering Department, and Quality Assurance Department.

ACCOUNTABILITY

Concerned Department Head

Unit Head

PROCEDURE

• Before resumption in routine use, all equipment shall be qualified as per the Equipment Qualification Matrix provided in the Validation Master Plan (VMP) or requirement based on the criticality of equipment in process and its impact on product quality.
• Equipment/System qualification shall include the following:

1. Design Qualification
2. Installation Qualification
3. Operational Qualification
4. Performance Qualification

Design Qualification [DQ]:

DQ defines the functional and operational specifications of the instrument and detail the conscious decisions in the selection of the supplier. DQ should ensure that instruments/system have all the necessary functions and performance criteria that will enable them to be successfully implemented for the intended application and to meet business and regulatory requirements.

Design Qualification should include these steps-

• Selection of the technique and/or type of equipment.
• Description of the intended environment.
• The description on how the instrument will be used in the selected environment and within a process. If the instrument will be used for several applications, describe a few typical scenarios.
• Preliminary selection of the supplier.
• Final selection of the equipment and qualification of the supplier and equipment.
• Discussion and documentation of warranty, Familiarization, Training, Consulting and other vendor services.
• Development and documentation of final functional and operational specifications.
• Review and approval of user requirements and functional specifications by user of the system and by the validation team.

Installation Qualification [IQ]:

Installation qualification establishes the documented evidences that the equipment is received as per designed specification and that it is properly installed and configured in the selected environment and for intended application.

Installation qualification shall include following steps:

• Check if the environmental and safety conditions, e.g., power condition requirements, meet the criteria as specified for the instrument.
• Compare equipment, as received, with purchase orders (including software, accessories, and spare parts).
• Check documentation for completeness (operating manuals, maintenance instructions, standard operating procedures for testing, safety and validation certificates).
• Check equipment for any damage.
• Install hardware (computer, equipment, fitting, and tubing for fluid connections, power cable, data flow, and instrument control cables).
• Switch on the instruments and ensure that all modules power up and perform an electronic self-test.
• Install the software on the computer following the manufacturer’s recommendation.

• Verify correct software installation, e.g., verify that are all files loaded. Utilities to do this should be included in the software itself.
• Make a backup copy of the software.
• Configure peripherals, e.g., printers and equipment modules.
• Identify and make a list with a description of all hardware, including drawings where appropriate.
• Make a list of all software installed on the computer with description.
• List equipment manuals and SOPs.
• Develop operation and calibration procedures.
• Prepare an installation report.

Operational Qualification [OQ]:

Operational Qualification (OQ) is the process of demonstrating that an instrument will function according to its operational specification in the selected environment. The instrument should be tested against critical performance specifications as specified in the Design Specifications.

Follow the following steps while carrying out Operational Qualification:

• Obtain functional and performance specifications (preferably use information from DQ).
• Identify critical functions that should be tested in the user environment.
• List the test cases to the user requirement and functional specifications as defined in DQ.
• Develop SOPs for testing.
• Test procedure shall include what to test how testing shall be conducted and the expected results with the acceptance criteria.
• Don’t use the manufacturer’s performance specification limits if the performance is expected to deteriorate over time. Take performance specifications as required by the application.
• Define the frequency of OQ as recommended by the vendor.

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Performance Qualification [PQ]:

Performance Qualification (PQ) is the process of demonstrating that an instrument consistently performs according to the specification appropriate for its routine

• Define test procedures and the performance criteria for the complete system selecting critical parameters.
• All qualification studies shall be executed as per the prescribed protocol Format for a particular qualification.
• Execution of Qualification studies may be acceptable on supplier/ vendor protocol format (If any) but provided that the same shall have the all necessary information required for respective qualification to meet the acceptance criteria.

• If Qualification is executed on supplier/ vendor document/protocol then Equipment and its parts number, calibration and preventive maintenance consideration or any other requirements which are not a part of Qualification protocol format may be attached as a supplement /Addendum /Appendices with Qualification document.
• If Qualification is executed on supplier/ vendor document/protocol and/or by supplier/ vendor then execution of Qualification should be verified by the Engineering and User Department and approved / Certified by Quality Assurance.
• The validation team shall prepare the protocol for installation and operational qualification of the instrument/equipment with the guidance of the functional department head.
• The validation team shall prepare the protocol for qualification of process, utilities wherever required, and process equipment in production.
• The head of the functional department shall arrange all the relevant information/documentation about each instrument/equipment from the manufacturer to support the validation document.
• The protocol for installation qualification & operational qualification shall be as per the general guidelines. The protocol for performance qualification shall be specific for the system/equipment to be validated as per the general guidelines.
• Each protocol shall be identified with a number as described below. But in case of AHU the numbering system will be different.
• The pattern of protocol numbering (except AHU) shall be as XXX/BBB/XXXXX/YY.

Where,

XXX – XYZ Limited

BBB - Validation Protocol type (IQP – Installation Qualification protocol, OQP –Operational Qualification Protocol & PQP – Performance Qualification Protocol).

XXXXX – Last Five digits numerical Identification number of equipment/instrument as per SOP of numbering system of various equipment/instrument. For QC Instrument six digits numerical Identification..

YY – Revision No. The first time prepared shall be numbered as 00, in case of the first revision it shall be 01.

e.g for first-time Installation Qualification of tablet Equipment shall be numbered as XXX/IQP/T-001/00.

• The pattern of protocol numbering of the AHU System shall be as XXX/BBB/AHU-XX/YY

Where,

XXX- Company name

BBB-Validation Protocol type (IQP – Installation Qualification protocol, OQP –Operational Qualification Protocol & PQP – Performance Qualification Protocol).

AHU- Air Handling Unit

- Dash

XX – Two digits serial number of AHU System.

YY – Revision No. The first time prepared shall be numbered as 00, in the case of the first revision it shall be 01.

e.g for the first time. Installation Qualification of AHU system no. 1 shall be number as XXX/IQP/AHU-01/00.

• Generally, protocols shall be approved by the Head QA, User Department, and Engineering Department or by their designee (if required). Wherever utilities and services are required Engineering Department support shall be taken.
• All the operations shall be checked by the performer with a sign and date in the report after the completion of each operation under checked by column.
• All the operations shall be verified by a second person with a sign and date after completion of each operation under checked by column.
• All the validation reports shall be certified by the head of QA, user Department, and Engineering Department or by their designee (if required).
• At the end of the validation activity task report shall be prepared which shall be approved by the Head QA, User Department, and Engineering Department.
• In case of any modification/change done to the qualified equipment based on the comments of the change control committee as per the SOP on “Change Control Program”, equipment shall be re-qualified (partial/ Full) through Supplementary protocol.

REFERENCES

Nil

ABBREVIATIONS

SOP: Standard Operating Procedure

QA: Quality Assurance

AHU: Air Handling Unit

QC: Quality Control

REVISION HISTORY

Nil

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