Sop for System Equipment

1.0 Purpose

This document describes the procedure for the installations, operational and performance qualification for the validation of system/equipment.

2.0 Scope

This document describes the procedure to ensure machine/equipment meets the specified requirements and is appropriately placed and installed as per manufactures recommendations.

3.0. Terms & Definitions

Terms	Definitions
IQ	Installation Qualification
OP	Operational Qualification
PQ	Performance Qualification
Validation	Establishing documented evidence which provides high degree of confidence that a specific system will consistently produce a product meeting its predetermined specifications and quality.
Installation/equipment qualification	The qualification of machine/equipment performs at the time of procurement of machine/equipment before routine operation.
Operation Qualification	The qualification of Machine/Equipment to ensure the proper operation of the machine/equipment.
Performance Qualification	The qualification of the machine to ensure the consistent performance of machine/equipment.
Validation Protocol	As in method validation.
HVAC	Heat Ventilation and Air Conditioning.

4.0 Responsibilities

a. Validation Manager

i. To manage the machine/equipment qualification according to schedule.

ii. To supervise the IQ, OP and PQ according to procedure in accordance with the relevant protocol.

iii. To take corrective action with the consent of Plant Manager if any deviation is observed during IQ, OQ and PQ.

iv. To review the qualification protocol and report and submits to Plant Manager for approval.

b. Engineering Manager

i. To conform the technical specifications as per supplier specifications

ii. To in list the main parts of the system/machine.

iii. To describe the functions of main parts of the Machine.

i. Officer (Validation)

ii. To prepare machine/equipment qualification protocol.

iii. To enter the findings of IQ, OQ and PQ in the machine/equipment qualification Report.

iv. To perform IQ, OQ and PQ according to relevant protocol.

v. To paste validation sticker after machine/equipment qualification.

5.0 Environment, Safety and Health Precautions

i. Safety aspects should also be considered during installation and operational qualification of system/equipment.

ii. During IQ and OQ all the electrical wires and cables should be checked.

iii. Do not insert finger in machine/equipment during operation.

iv. Check the Safety alarm and safety switches if applicable.

During IQ and OQ if any drawback is observed regarding safety, it should be highlighted in the relevant protocol

1.0 6.0 Procedure

The Validation Protocol for System / Equipment are divided into three segments

a. Installation Qualification (IQ)

This document is prepared for each critical processing system/ equipment. The IQ describes the name, description, model, identification number, location, utility requirement, connections and any safety features of the equipment. The IQ verifies that the equipment matches the purchase specifications, and that all drawing, manuals, spare parts list, vendor address and contact number and other pertinent documents are available.

b. Operational Qualification (OQ)

This document outlines the information required to provide that all the components of system/ equipment operate as specified. The OQ documents provides the acceptance criteria for all operations and the references of SOP’s for operation, maintenance, calibration, instructions for any tests to show that the equipment operates as expected under normal as well as worst possible conditions.

c. Performance Qualification (PQ)

The PQ for system/equipment is performed after IQ and OQ are completed. The PQ describes the procedures for demonstrating that the system or equipment can consistently perform and meet the required specifications under the routine operation. The PQ includes the description of the preliminary procedures required, the detailed performance tests to be done, and the acceptance criteria for each test. The PQ required that all supporting equipment used during the PQ have been calibrated.

d. System/Machine/Equipment

For equipment whose correct operation is a sufficient indicator of its function and that are monitored and/or calibrated on a regular schedule only IQ and OQ are performed and are said to be validated.

For systems such as HVAC, Air, Water, Steam, and major machine/equipment which perform critical support activities such as Sterilization, Washing etc IQ, OQ, and PQ are performed to be called as validated systems.

In case of any deviations observed during IQ, OQ, and PQ note the deviation along with the impact of deviation, and take corrective action if required.

The system/equipment Qualification is performed as mentioned in Master Validation Plan by the (Will be prepare by Validation Department) in coordination of engineering department in accordance with machine/equipment protocol and results are recorded in Machine/Equipment Qualification Report.

Validation Manager develops the System/ Equipment Qualification Protocol before commencing of validation studies; following are the main features of the System/ Equipment Qualification Protocol,

i. Abstract:

A brief description of all the activities that will be performed during Validation study.

ii. Objective:

iii. Scope:

iv. Requirement:

Briefly describes the applicability of the performance qualification of the System/ Equipment along with along with the Installation and Operational Qualifications.

v. Observation:

Observation and brief description of any minor/ major deviation that encountered during the comprehensive study of the Installation, Operation and Performance Qualification.

vi. Impact of Deviation:

vii. Corrective Action:

Reference of Corrective action taken in response of any deviation.

viii. Conclusion:

Validation manager (Validation Department) compiles the machine/equipment qualification report followings are the prerequisite of the machine/equipment qualification report.

i. References:

Facilities/Responsible Personnel/Equipment/Material & Documentation:

ii. Installation Qualification:

· A detailed description of the system should be included as a part of IQ; this description includes all important major/minor components of the machine.

· Brief description of system supporting utilities (e.g., electricity, compressed air etc.) and to evaluate the installation and connection of supporting services and utilities.

· To conform that the design specification, Engineering Drawings, Manuals, data sheets and Purchase order are available.

· Indicate the operating parameters i.e. the critical check points along with the parameters that required calibration

· To verify the availability of the applicability SOP’s, these must include machine operation, maintenance, calibration & cleaning.

· To mention any exceptional condition (deviation) encountered during the IQ that could effect process integrity or product reproducibility, are identified, investigated and documented (including justification, correction, and any necessary requalification studies if required).

· A checklist having statements for verification and applicability for installation qualification.

iii. Operational Qualification:

· A detailed description of the operation of the major/minor components of the machine.

· Description and identification of the parameters that require Calibration

· References of Calibration results.

· Effectiveness of the relevant SOP.

· Measure and record the results of specific challenges to the system in normal and worst case situation where appropriate.

· A checklist having statements for the verification and the applicability of the operation of the machine.

· Brief description of the safety features,

· Control Points and Alarm

· Specific Challenges to the System/ Equipment.

viii. Performance Qualification:

i. Assess the performance for

· Equipment:

Run normal procedure three times for each use (configuration or load) and record all required data and any deviation to the procedure

· System:

Monitor the system for 10 consecutive days, recording all required data and any deviation to the procedure.

ii. Perform all required calculations and statistical analysis.

iii. Compare the results to acceptance criteria.