Operational Qualification (OQ) Protocol & Report Format In Pharmaceuticals.

Operational Qualification (OQ) In Pharmaceuticals.

Systems and equipment should operate correctly and their operation should be verified in accordance with an operational qualification protocol.
Critical operating parameters should be identified. Studies on the critical variables should include conditions encompassing upper and lower operating limits and circumstances (also referred to as “worst case conditions”).

Operational qualification should include verification of operation of all system elements, parts, services, controls, gauges and other components. There should be documented records for the verification of operation
(operational qualification report) to indicate the satisfactory operation.Standard operating procedures for the operation should be finalised and approved.
Training of operators for the systems and equipment should be provided, and training records maintained.
Systems and equipment should be released for routine use after completion of operational qualification, provided that all calibration, cleaning, maintenance, training and related tests and results were found to be acceptable.

Format for Operational Qualification Protocol

Validation Protocol_______ Operational Qualification _______ Page_____ Of_____

Title:__________________ Name and address of site :_________________________

Validation Protocol :_____________________ OQ Protocol Number_______________

Title:________________________________________________

Protocol Written By:_____________________________

Protocol Approved By:_______________ Date:_______

QA Approval :______________ Date:_____________

Objective:-

To ensure that the (System/Equipment) operates according to specifications and to record all relevant information and data to demonstrate that the (System/Equipment) functions as expected.

Scope:-

To perform after installation, Modification or Relocation after the Installation qualification has been completed.

Responsibility:-

Person responsible for operating the system/equipment will perform the qualification and record the information.

The supervisor will supervise the study, verify the completion of the records, write the deviation report and the Operational Qualification (OQ) Report.

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

A. Materials, Equipment, Documents

List of calibration equipment required (Chart 1).

Materials or supplies needed to perform the Operational Qualification

1 ______________________________ Code # __________
2 ______________________________ Code # __________
3 ______________________________ Code # __________
4 ____________________________________________________________ Code # __________
5 ____________________________________________________________ Code # __________
6 ____________________________________________________________ Code # __________

SOPs and datasheets for normal operations of the system under test (Chart 2). Training records documenting that operators have been trained (Chart 2).

Manuals for equipment (Chart 2).

Procedure:-

Test and record calibration data for calibrating apparatus and instruments (Chart 1).

Test and record operative condition of control points and alarms (Chart 3).

Test and record outputs (Chart 4).

List of calibration requirements for the system under test and records of the calibration of the system (Chart 5).

Measure and record the results of specific challenge to the system in normal and worst case situation where appropriate (Chart 6).

Record any deviations to the procedures performed.

Prepare a Deviation Report including the justification of acceptance and impact on the operation.

Prepare an Operational Qualification Report. This should include date study initiated; date completed; observations made; problems encountered; completeness of information collected; summary of deviation report; results of control/alarm tests; sample data if appropriate; location of original data; other information relevant to the study; and conclusions on the validity of the equipment/system operations.
Submit QA for review and approval.

Preparation:-

Chart 1: Calibrating apparatus and instruments.

Apparatus/Instrument Calibration method Calibration date
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________
_____________________ ________________________ _______________________

Performed by: _____________________________________________ Date ____________
Deviations: ____________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________

Verified by: ________________________________________________ Date ____________

Preparation:-

Chart 2: Document check

SOP Title and number File location QA/QC approval date
______________________________ ___________________________ _______________________
______________________________ ___________________________ _______________________
______________________________ ___________________________ _______________________
______________________________ ___________________________ _______________________
______________________________ ___________________________ _______________________

Training Records:-

Course on SOP # Staff name Date
_________________________ _________________________________________ ______________
_________________________ _________________________________________ ______________
_________________________ _________________________________________ ______________
_________________________ _________________________________________ ______________
_________________________ _________________________________________ ______________

Equipment Make and Model Manual Available
______________________________________________________________ Y [ ] N [ ]
______________________________________________________________ Y [ ] N [ ]
______________________________________________________________ Y [ ] N [ ]

Performed by: _______________________________________________________ Date ____________
Deviations: ____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Verified by: ___________________________________________________________ Date ____________

Results:-

Chart 3: Control points and alarms.

Control Point/Alarm Results Date
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________

Performed by: _____________________________________________ Date ____________
Deviations: ________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________

Verified by: ________________________________________________ Date ____________

Results:-

Chart 4: Outputs

Outputs Results Date
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________

Performed by: _____________________________________________ Date ____________

Deviations: _________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________

Verified by: ________________________________________________ Date ____________

Chart 5: Calibration of Equipment/System

Calibration SOP Result Date
(short title and #)
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________
_____________________ ______________________________________ _______________

Performed by: _____________________________________________ Date ____________
Deviations: _______________________________________________________________________
___________________________________________________________________________________
___________________________________________________________________________________
Verified by: ________________________________________________ Date ____________

Chart 6: Specific challenge of the equipment or system

Test in normal conditions:

________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
Test of worst case situation:
(e.g. start-up after shutdown, temperature recovery time, centrifuge imbalance)

________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Performed by: _____________________________________________ Date ____________
Deviations: ________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Verified by: ________________________________________________ Date ____________

Deviation Report:-

Deviations:- ________________________________________________________________________________________
________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Justification For Acceptance :- ________________________________________________________________________________________
________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Impact On Operation:-

________________________________________________________________________________________
________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Report Written By :___________________________________ Date: ________________________

Operational Qualification Report :-

Results:- ________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Conclusions:-

________________________________________________________________________________________
________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Report written by:- ____________________________ Date:- _______________________________

QA Approved By :- ____________________________ Date:- ________________________________

Reference :-

WHO – Quality Assurance Pharma Vol2.

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.