Installation Qualification (IQ) Protocol and Report in Pharmaceuticals  

Installation Qualification (IQ) Protocol and Report in Pharmaceuticals.

 

Installation Qualification:- Systems and equipment should be correctly installed in accordance with an installation plan and installation qualification protocol. Requirements for calibration, maintenance and cleaning should be drawn up during installation. Installation qualification should include identification and verification of all system elements, parts, services, controls, gauges and other components. Measuring, control and indicating devices should be calibrated against appropriate national or international standards, which are traceable.

There should be documented records for the installation (installation qualification report) to indicate the satisfactoriness of the installation, which should include the details of the supplier and manufacturer, system or equipment name, model and serial number, date of installation, spare parts, relevant procedures and certificates. Systems and equipment should be appropriately designed, located, installed, operated and maintained to suit their intended purpose.

Critical systems, i.e. those whose consistent performance may have an impact on the quality of products, should be qualified. These may include,where appropriate, water purification systems, air-handling systems, compressed air systems and steam systems.

Validation Protocol_______ Installation Qualification ________Page_____ Of_____

Title:__________________ Name and address of site :_____________________________

 

Validation Protocol :_____________________ IQ Protocol Number________________

Title:__________________________________________________________________________

Protocol Written By:__________________________________________________________

Protocol Approved By:_______________________________     Date:________________

QA Approval :_______________________________________      Date:________________

 

Objective:-

To ensure that ________ (System/Equipment) installed conforms to the purchase specifications and the manufacturer details and literature, and to documents the information that  ____________________ (System/Equipment) meets its specifications.

Equipment Inventory Number: ____________________________________________________

 

Scope:-

To  perform installation qualification as described in this IQ Protocol at the time of installation , Modification and Relocation.

 

Responsibility:-

____________________ ( Post/Person ) overseeing the installation will perform the qualification and record results.

____________________ ( Post/Person ) will verify results and write the report.

Quality Assurance will review and approve the IQ protocol and Report.

 

System/Equipment: _______________________________ Code No:_________________

A. Description of the System/equipment being installed: general description of the function and the main components.




 

B. List of the main Components:-

1.

2.

3.

4.

 

C. Description of supporting utilities (e.g. piping, connections, water supply) :-

1.

2.

3.

4.

Procedure:-

  1. prepare a checklist of all components and parts, including spare parts according to the purchase order and manufacture’s specifications.
  2. 2.Record the information for each actual part, component, item of auxiliary equipment, supporting facilities, and compare with the manufacturer’s specifications.
  3. Record any Deviations to the System/Equipment.
  4. Prepare a deviation report including justification of acceptance and impact on the function.
  5. Prepare an IQ Report.
  6. Submit the report to QA for review and approval.

Note:- As a Minimum, the IQ report should Include the date of installation of the study, date completed, observations made, problems encountered, completeness of information collected, summary of deviation reports, result of any tests, sample data, location of original data, other information relevant to the study , and the conclusion on the validity of the installation.

 

Checklist for component No:_________________________________

Name: _____________________________________ Code No: ____________________________

Component Function : ___________________________________________________________

 

Sr. No. Components Require/order Actual Deviations
1. Serial No.
2. Specification
3. Manua
4. Drawing
5. Writing/Cabing
6. Power, Fusing
7. SOP (Operation)
8. SOP (Maintenance)
9. SOP(Calibration)
10. Input/Output Control
11. Environment
12. Test Equipment Or Instruments
13. Utilities and Service
14. Spare parts list, Part Number and Suppler
15. Other
 

Performed By:- ________________________________________  Date:- __________________

Deviations:- __________________________________________   Date:- __________________

Verified By:- __________________________________________   Date:- __________________

 

 

Deviation Report:-

Deviations:- ________________________________________________________________________________________


 

Justification For Acceptance :- ________________________________________________________________________________________


Impact On Operation:-



Report Written By :___________________________________ Date: ________________________

 

Installation Qualification Report :-

Results:- ________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Conclusions:-



Report written by:- ____________________________ Date:- _______________________________

QA Approved By :- ____________________________ Date:- ________________________________

Reference :-

WHO – Quality Assurance Pharma Vol2.

 

 

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