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Installation Qualification in Pharma And Operational Qualification

Installation Qualification in Pharma And Operational Qualification

The(IQ) Installation Qualification Protocol verifies the proper installation and configuration of a System. This can include ensuring that s necessary files have been loaded, the equipment has been installed, the necessary procedures have been approved, and the appropriate personnel has been trained.

Installation qualification Procedure

The testing, including running testing, demonstrates that an individual piece of equipment is mechanically complete and safe to operate. The validation of readiness of equipment and controls for equipment start. Includes mechanical, electrical, instrumentation, and controls. 

IQ tests are performed for the tagged item and do not include adjacent tagged items. Connected pipe, duct, and both power and control circuits must be successfully tested before IQ tests are conducted for the tagged equipment.

IQ generally occurs in three phases:

IQ1:

Visual conformance to Process Description, P&ID's, General Arrangement drawings, equipment specifications and layout drawings.

Review the observations and suggested actions, if any, in the EQ report.

Visual conformance to a good standard of installation, correct support of cabling and pipes, absence of dead legs, etc.

Verification that the Plant can be utilized as planned, installation is tidy and organized and installation is hygienic.

Mechanical checks of tagged equipment (pipe connections, electrical terminations, anchor bolts tight, etc.)Cold loop testing

The direction of rotation checks

Plant electrical safety audit

Plant hygienic installation audit

IQ2

Running tests

Hot loop testing

SAT (automation hardware integration tests)

Water flush, leak testing, and hydro testing

IQ3

Tests described in IQ1 and IQ2 for the equipment that cannot be installed until other installations have been completed and tested (e.g. mass flow meters, control valves etc.)

If a fault is detected, it must be rectified before proceeding. Any change must be recorded.

Release of equipment

When all critical instrumentation/parameters has been checked and considered to be satisfactory, it is the responsibility of commissioning team to complete form No. stating that the equipment has passed all IQ requirements.

Documentation

The original report will be retained by the Document Controller / Validation Incharge

Installation qualification checklist

Customer Name



Instrument Make



Instrument Name



Maximum Capacity



Address Of Manufacture  Supplier



Power Requirements



Suitable for / Testing



Accessories



Caution if any


Date of installation



Installation Done by



                                                                                         

 Prepared By                               Verified By:


Acceptance Criteria:-

a)    Analysis of 3 Batches  should matches of Specification of Performed Sample & RSD is NMT2%


Parameter

Acceptance Criteria



Results Acceptance (3sample)

RSD NMT 2%


Qnstallation Qualification

Purpose of installation qualification

The purpose of installation qualification Verifies the protocol proper installation and configuration of systems. The necessary have been approved, and equipment has been installed.

OQ: Verified the protocol and the proper collection of test case results used to verify the functioning of a system.

Instrument Performance:-

Materials Name:  (XXXX)

Sample No

Test

Limit

Actual

RSD NMT 2%

Remarks

A

(GRN,NO: 09)




-


B

(GRN,NO: 18)




-


C

(GRN,NO: 24)






PROTOCOL FOR OPERATIONAL QUALIFICATION

Name of equipment

:

 

REMARKS

Tag Number

:

 

 

Situated at

:

 

 

PURPOSE

:

 

 

SCOPE

:

 

 

PRE-REQUIREMENT

 

Installation Qualification

:

 

 

Utilities

:

 

 

Protocols

:

 

 

Controls

:

 

 

Warning devices Guards and Safety Interlocks

:

 

 

Indicators

:

 

 

Establish Variable Operational parameters

:

 

 

Acceptance criteria

 

 

 

REPORTING AND CERTIFICATION

:

 

 

Change Control

:

 

 

Downloads operational qualification Procedure = Click Here


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