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129 views13 pages

Oq TD

oq

Uploaded by

Nur Nabi Rashed
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
You are on page 1/ 13

OPERATIONAL QUALIFICATION FOR TRAY DRYER Page:1 of 13

CUSTOMER: M/S ZOHA HOMEO PHARMACEUTICALS LABORATORIES

OPERATIONAL
QUALIFICATION
FOR
TRAY DRYER
Machine Serial Number: TEE/00190
OPERATIONAL QUALIFICATION FOR TRAY DRYER Page:2 of 13

CUSTOMER: M/S ZOHA HOMEO PHARMACEUTICALS LABORATORIES

TABLE OF CONTENTS FOR TRAY DRYER MACHINE OQ

S. TITLE PAGE
No. No.
1. Approval 3
2. Objective 4

3. Responsibility 4

4. System Description 5
5. Pre-requisite of Operational Qualification 5
6. Operational Qualification Procedure 5

7. Training of concern personnel 6


8. Critical Instrument Calibration 6
9. Key Functionality Test 6
10. Test Data Report Sheet 7
11. Safety key Features Test 7

12. SOP Verification 8


OPERATIONAL QUALIFICATION FOR TRAY DRYER Page:3 of 13

CUSTOMER: M/S ZOHA HOMEO PHARMACEUTICALS LABORATORIES


13. Deviation Details(If Required) 8

14. Change Control (If Required) 8

15. Revalidation Criteria 8

16. Acceptance Criteria 8

17. Summary Report 8

1.0 PROTOCOL PRE-APPROVAL:

PREPARED BY: (MYTH INDUDTRIES)


DESIGNATION NAME SIGNATURE DATE
ENGINEER

REVIEWED BY: (ZOHA HOMEO PHARMACEUTICALS LABORATORIES.)

DESIGNATION NAME SIGNATURE DATE


HEAD
(PRODUCTION)
HEAD
(ENGINEERING)
OPERATIONAL QUALIFICATION FOR TRAY DRYER Page:4 of 13

CUSTOMER: M/S ZOHA HOMEO PHARMACEUTICALS LABORATORIES

APPROVED BY: (ZOHA HOMEO PHARMACEUTICALS LABORATORIES)

DESIGNATION NAME SIGNATURE DATE


HEAD
(QUALITY ASSURANCE)

GROUP MEMBERS:

S/L NO. COMPANY DESIGNATION SIGNATURE DATE

1.

2.

3.

4.

5.

6.

2.0 OBJECTIVE OF TRAY DRYER MACHINE OQ: –


The purpose of operational Qualification protocol is: –
OPERATIONAL QUALIFICATION FOR TRAY DRYER Page:5 of 13

CUSTOMER: M/S ZOHA HOMEO PHARMACEUTICALS LABORATORIES


 To qualify the equipment for its operational attributes of equipment.
 To ensure that the major critical instruments identified in the Installation Qualification protocol are
calibrated.
 To establish that the Equipment operates within it’s desired operating ranges.
 To assure that the Equipment serves the intended purpose.
 To establish the draft SOP prepared for the operation ,cleaning and preventive maintenance of
equipment.
3.0 RESPONSIBILITY: –
The validation team comprising of a representative from each of the following concern departments shall
be responsible for the overall compliance with this Qualification protocol:
 Engineering Department
 Production Department
 Quality Assurance Department
 The Production and Engineering shall be responsible for checking the operation and recording
operational data as per the procedures outlined in this protocol.
 The Manager Engineering shall be responsible for verifying the data recorded in the Operational
Qualification Protocol.
 The Quality Assurance Department shall be responsible for the final review of the qualification
documents and its compliance to meet the acceptance criteria of the Operational Qualification protocol.
OPERATIONAL QUALIFICATION FOR TRAY DRYER Page:6 of 13

CUSTOMER: M/S ZOHA HOMEO PHARMACEUTICALS LABORATORIES

4.0 SYSTEM DESCRIPTION: –


A tray dryer is widely used industrial drying equipment designed to remove moisture from various substances,
typically in batch quantities. It consists of a stack of trays or shelves where the material to be dried is placed.
These trays are then subjected to controlled hot air circulation, leading to the evaporation of moisture from the
materials.

Tray dryers consist of several essential components, including:

Chamber: The main housing where the trays are stacked and drying occurs.

Trays: Shelves where materials are placed for drying.

Heating System: Generates hot air for the drying process.

Air Circulation System: Ensures even distribution of hot air within the chamber.

Exhaust System: Expels moisture-laden air from the chamber


5.0 PRE REQUISITE OF TRAY DRYER MACHINE OQ (OPERATIONAL QUALIFICATION): –
 Ensure the cleanliness of the area where equipment to be installed.
 Equipment should be installed properly as defined in Installation Qualification protocol of the equipment.
OPERATIONAL QUALIFICATION FOR TRAY DRYER Page:7 of 13

CUSTOMER: M/S ZOHA HOMEO PHARMACEUTICALS LABORATORIES


 All the utilities are connected properly and verify for Operational.
 All the Electrical connections are connected properly and verify for Operational.
 The training has been imparted to the all concern personnel including validation team team for conducting
Operational Qualification.

6.0 TRAY DEYER OQ (OPERATIONAL QUALIFICATION) PROCEDURE: –


 A draft SOP’s shall be prepared on the basis of supplier guide for operation,cleaning and preventive
maintenance before the qualification testing.
 Prior to the operational qualification test, the concern personnel shall be trained by the engineer from the
supplier on the operational features of the equipment / system this training shall be recorded.
 Calibrate the critical instruments located on the equipment (as identified during installation qualification)
as per in house SOP of the instrument calibration or the manufacturer’s instruction. Record the date of
calibration & due date.
 The trained personnel shall carry out the Operational Qualification and record the observations of
qualification test.
 Operate the equipment as per the draft SOP’s, record the change if any and confirm the SOP’s.
 Report the deviations if any observed.
OPERATIONAL QUALIFICATION FOR TRAY DRYER Page:8 of 13

CUSTOMER: M/S ZOHA HOMEO PHARMACEUTICALS LABORATORIES

7.0 TRAINING DETAILS: – The Concern personnel and validation team should be qualified for Operation of the
equipment by supplier’s representative / qualified person.
Title: Operation, function and troubleshooting procedure of equipment.

 Name of the Trainer:


S. No. Name of the Employee Number Designation Signature
Trainee

1.

2.

3.

4.

5.

8.0 INSTRUMENT CALIBRATION: –Calibrate the critical instrument as identified below prior to operation of the
equipment.
S. No. Name of the Location Calibration Calibration Calibrated by
Instrument Done on Due on
1. Pressure Near incoming air
Gauges.
2. Pressure Near discharge
Gauges. chute.
3. Pressure For Tonnage
Gauges.
OPERATIONAL QUALIFICATION FOR TRAY DRYER Page:9 of 13

CUSTOMER: M/S ZOHA HOMEO PHARMACEUTICALS LABORATORIES

9.0 KEY FUNCTIONALITY DURING TRAY DRYER MACHINE OQ: –


Purpose:
 The purpose of this procedure is to demonstrate that the control panel and other manual operations of
Tablet Compression Machine function as specified by the manufacturer.
Testing:
 Check all the displays on the panel are identified.
 Turn on the power from the electrical panel.
 Set the control on the panel.
 Verify functionality of each component on the control panel against its Specified functions.
 Red switch for main electric supply ON / OFF
 Mushroom head red emergency stop button
 Observe and record the responses in the Testing Data Sheet

10.0 TESTING DATA SHEET FOR TRAY DRYER MACHINE OQ: –

Set Temperature (°C) Actual Observed Temperature (°C)


Trial 1 Trial 2 Trial 3

 Time required to reach temperature: In this study, the time was noted down after reaching the
OPERATIONAL QUALIFICATION FOR TRAY DRYER Page:10 of 13

CUSTOMER: M/S ZOHA HOMEO PHARMACEUTICALS LABORATORIES


temperature and the results were tabulated as shown in Table.

Temperature (°C) Time

11.0 SAFETY FEATURES TEST FOR TRAY DRYER OQ (If applicable)


S. No. Safety Feature Description Specified Function Observations Checked By
1. Low compressed air. Machine status will indicate
low air pressure in red.
2. Safety Guard Machine will not running
auto mode while gate is
open.
3. Reason entry Machine will not re-start
without entering proper
stopping reason.
4. Stop during continuous Machine will stop while
rejection. rejection will continuous.

12.0 SOP VERIFICATION DURING TRAY DRYER MACHINE OQ:


S. No. SOP Title Draft Verification Date Operated By
SOP No.
1. Operating
OPERATIONAL QUALIFICATION FOR TRAY DRYER Page:11 of 13

CUSTOMER: M/S ZOHA HOMEO PHARMACEUTICALS LABORATORIES

2. Cleaning
3. Preventive Maintenance

13.0 DEVIATION DETAILS (If Applicable):


………………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………………
……………………..

14.0 CHANGE CONTROL (If Applicable):


………………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………………
……………………..

15.0 RE-VALIDATION CRITERIA:


 Operation Qualification to be re-qualified on
 Replacement of major component of the equipment with a new component.
 Any major modification in the existing equipment
 Shifting of the equipment from one location to another
 During monitoring if equipment is found to be malfunctioning

16.0 ACCEPTANCE CRITERIA FOR TRAY DRYER MACHINE OQ:


 Operational Qualification shall be considered acceptable when all the conditions specified in various
have been met.

17.0 SUMMARY FOR TRAY DRYER MACHINE OQ:


OPERATIONAL QUALIFICATION FOR TRAY DRYER Page:12 of 13

CUSTOMER: M/S ZOHA HOMEO PHARMACEUTICALS LABORATORIES


………………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………………
………………………………………………………
OPERATIONAL QUALIFICATION FOR TRAY DRYER Page:13 of 13

CUSTOMER: M/S ZOHA HOMEO PHARMACEUTICALS LABORATORIES

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