BF Biosciences Limited Doc. No.
QC-QD-007-00
Effective Date: 20.10.2010
ROOM QUALIFICATION Review Date 20.10.2013
Page Page 1 of 19
Microbiology Culture Room
Signature and
Na me Designation
date
Written By: Technical Validation Group
a) Tahir Zaman Electronics Technician ………………
b) ………………
Reviewed By: Leader Technical Validation
Group
a) Muhammad Tahir Iqbal Operations Manger ………………
Approved By: Corporate Validation Group
a) Ejaz Ahmed Manager Quality Operations ………………
b) Shams-Ul-Arifeen Production manager ………………
c)S.M. Azher Quality Control Manager ………………
d) Muhammad Tahir Iqbal Operations Manager ………………
e) Asadullah Khan Assistant Manager Microbiology ………………
Authorized By: Dr. Ajmal Nasir Director Technical ………………
BF Biosciences Limited Doc. No. QC-QD-007-00
Effective Date: 20.10.2010
ROOM QUALIFICATION Review Date 20.10.2013
Page Page 2 of 19
Microbiology Culture Room
INSTRUCTIONS FOR DOCUMENTATION COMPLETION
All performers and reviewers must complete qualification forms using the following
guidelines:
Complete all items on a form in full, except the optional comment’s section.
Document any deviation from defined protocols and accepted results. Owner
approval of protocol deviations must be documented before final approval
signatures can be obtained.
Write additional comments on an addendum sheet when there is not enough
space on a form to accommodate all comments. Use these three steps when
adding an addendum sheet.
1. Number the page alphanumerically.
2. Initial and date additions.
3. Insert the addendum sheet behind the original page.
Make all entries in permanent black or blue ball pen.
CORRECTING ENTRIES
If you need to make corrections on a form, use the procedures described below:
CORRECTING SHORT ENTRIES
To correct a short entry [such as a single word or test result] on a form:
1. Draw a diagonal line, bottom left to upper right, through the miss
entered or incorrect information.
2. Write the correction to the upper right of the original entry.
3. Give brief explanation of change
4. Initial and date the change.
BF Biosciences Limited Doc. No. QC-QD-007-00
Effective Date: 20.10.2010
ROOM QUALIFICATION Review Date 20.10.2013
Page Page 3 of 19
Microbiology Culture Room
INSTRUCTIONS FOR DOCUMENTATION COMPLETION
CORRECTING LONG ENTRIES
To correct a long entry or information block on a form:
1. Draw a diagonal line, bottom left to upper right, through the miss
entered or incorrect information.
2. Write the correction on a separate addendum page.
3. Give brief explanation of change.
4. Initial and date the changes.
5. Number the page alphanumerically
6. Place the addendum page behind the original page.
MARKING ELEMENTS THAT ARE NOT APPLICABLE
Mark each element carefully according to the instruments below, so that it will be clear
that the element is unnecessary and that you have not skipped or forgotten the
element.
1. Draw a diagonal line, bottom left to upper right corner, through the
element that is not required.
2. Write the letters NA [Not Applicable], your initials, and the date above
the line. Include comments above the line or on the form to document
the reason the element is not required.
3. Where NA is indicated as an option, select this field.
The performer and reviewer must sign and date all forms, as usual, even when part or
all of the form is marked “NA”.
NOTE: ALL ORIGINAL ENTRIES MUST REMAIN LEGIBLE AFTER ANY CORRECTIONS HAVE BEEN
MADE.
BF Biosciences Limited Doc. No. QC-QD-007-00
Effective Date: 20.10.2010
ROOM QUALIFICATION Review Date 20.10.2013
Page Page 4 of 19
Microbiology Culture Room
INSTRUCTIONS FOR DOCUMENTATION COMPLETION
CAUTION
The following conditions require “re-qualification”;
When a Instrument modification has been completed, it affects the installation
qualification.
When the software or firmware has been upgraded or changed
When this Instrument is being removed from where it was originally installed.
RE-CALIBRATION / RE-CERTIFICATION REQUIREMENTS
The following conditions require “re-calibration / re-certification;
For a pre-determined period of time or use.
After any minor service has been done or replacement or parts.
When this Instrument is being removed from where it was originally installed.
BF Biosciences Limited Doc. No. QC-QD-007-00
Effective Date: 20.10.2010
ROOM QUALIFICATION Review Date 20.10.2013
Page Page 5 of 19
Microbiology Culture Room
INSTALLATION QUALIFICATION IQ
TABLE OF CONTENT
SECTION DESCRIPTION PAGE
1.0 Objective 6
2.0 Responsibility 6
3.0 Acceptance criteria 7
4.0 Room Description 7
4.1 Room Identification 7
4.2 Sub Component 7
4.3 Room Detail 8
4.4 Related Documents 9
4.5 Installation site requirements 10
5.0 Installation Qualification Procedure 11
5.1 Un packing 11
5.2 Electric Connection 11
5.3 Installing Tube Lights 11
5.4 Installing Automated Temperature Probe 12
5.5 Power on 12
6.0 Deviation 13
7.0 Reason for acceptance 13
8.0 Conclusion
Written By Reviewed By Approved By
Signature Signature Signature
& Date & Date & Date
Name Name Name
Title Title Title
BF Biosciences Limited Doc. No. QC-QD-007-00
Effective Date: 20.10.2010
ROOM QUALIFICATION Review Date 20.10.2013
Page Page 6 of 19
Microbiology Culture Room
INSTALLATION QUALIFICATION IQ
Section 1.0 Objective:
The objective is to verify that the Microbiology culture Room at safe environment and
all Equipment were installed and tested as per DQ requirements and performs its
functions as per specification.
Section 2.0 Responsibility:
Technical Validation Group (TVG)
- Writing of protocol
- Collection of data.
- Analysis of data.
- Execution of protocol.
Leader TVG
- Review of protocol execution and correction of data interpretation.
- Submission of executed protocol to CVG for Approval
Corporate Validation Group (CVG)
- Approval of protocol and its execution of validation exercise.
- Final conclusion of validation.
- Exercise approval
Director Technical
- For Authorization and
a) final conclusion approval
b) Approval of validation exercise.
Written By Reviewed By Approved By
Signature Signature Signature
& Date & Date & Date
Name Name Name
Title Title Title
BF Biosciences Limited Doc. No. QC-QD-007-00
Effective Date: 20.10.2010
ROOM QUALIFICATION Review Date 20.10.2013
Page Page 7 of 19
Microbiology Culture Room
INSTALLATION QUALIFICATION IQ
Section 3.0 Acceptance Criteria:
- All instruments installed as recommended by manufacturer
- The instruments type and operation limits match with specification
Recommended and state in purchase order.
- Make and model is same as stated in Purchase Order.
- Equipment and instrument was in perfect working condition
- Installation document provided by the service engineer of supplier available
Section 4.0 Room Description:
Microbiological Culture Room is According to the Provide Dimensions and also
Adjunct for Documentation. Safety Cabinet Level 2 According to the
Requirements. Room Has Space for Refrigerator. Microscope is also provided.
Temperature probe also installed.
Section 4.1 Room Identification:
ROOM NAME MICROBIOLOGY LAB
ROOM NUMBER 104
LOCATION
Quality Control
INSTALLATION QUALIFICATION IQ
Written By Reviewed By Approved By
Signature Signature Signature
& Date & Date & Date
Name Name Name
Title Title Title
BF Biosciences Limited Doc. No. QC-QD-007-00
Effective Date: 20.10.2010
ROOM QUALIFICATION Review Date 20.10.2013
Page Page 8 of 19
Microbiology Culture Room
Section 4.2 Sub Components
DESCRI
S. NO. CHECK
PTION
1 Electrical Connection
2 Structure According Drawing
3 Air Conditioning Incoming Grill
4 Air Conditioning Outgoing Grill
5 Biological safety Cabinet Level 2
6 Table as Sufficient with Cabinet
7 Space for Refrigerator
8 Biological Microscope
9 Adequate Spac for Washing need
10 Door Lock
11 Telephone & Internet Facility
Written By Reviewed By Approved By
Signature Signature Signature
& Date & Date & Date
Name Name Name
Title Title Title
BF Biosciences Limited Doc. No. QC-QD-007-00
Effective Date: 20.10.2010
ROOM QUALIFICATION Review Date 20.10.2013
Page Page 9 of 19
Microbiology Culture Room
Room Details
Temperature 25°C ±2°C
Test result was successfully achieved: ______________________ ( YES / NO *)
Examiner:_____________ Date: _____________Signature:________________
Verified By: _____________ Date: _____________Signature:________________
Remarks(if any):
If test result “NO” then see Deviation sheet No.:______________
Written By Reviewed By Approved By
Signature Signature Signature
& Date & Date & Date
Name Name Name
Title Title Title
BF Biosciences Limited Doc. No. QC-QD-007-00
Effective Date: 20.10.2010
ROOM QUALIFICATION Review Date 20.10.2013
Page Page 10 of 19
Microbiology Culture Room
INSTALLATION QUALIFICATION IQ
Section 4.4 Related Documents
PURCHASE ORDER NUMBER
DOCUMENTATIONS CHECK DOCUMENT
NO.
Operation Manual Available N/A ___________
Warranty Certificate Available N/A ___________
Standard Operating Available N/A ___________
Procedure
Test result was successfully achieved: ______________________( YES / NO *)
Examiner:_____________ Date: _____________Signature:________________
Verified By: _____________ Date: _____________Signature:________________
Remarks(if any):
If test result “NO” then see Deviation sheet No.:______________
INSTALLATION QUALIFICATION IQ
Written By Reviewed By Approved By
Signature Signature Signature
& Date & Date & Date
Name Name Name
Title Title Title
BF Biosciences Limited Doc. No. QC-QD-007-00
Effective Date: 20.10.2010
ROOM QUALIFICATION Review Date 20.10.2013
Page Page 11 of 19
Microbiology Culture Room
Section 4.5 Installation Site Requirements
4.5.1 ELECTRICAL
IN PUT: 240V Actual: _______________
OUTPUT: Actual: _______________
IN PUT: Actual: ______________
OUT PUT: Actual: _______________
4.5.2 OPERATING Environment
TEMPERATURE: 25C ±2C Actual: _______________
HUMIDITY: 5 to 85% Actual: ______________
PHYSICAL SITE: Free of Vibrations
Free of heat Radiation
No aggressive / corrosive Substance
Even surface
INSTALLATION QUALIFICATION IQ
Written By Reviewed By Approved By
Signature Signature Signature
& Date & Date & Date
Name Name Name
Title Title Title
BF Biosciences Limited Doc. No. QC-QD-007-00
Effective Date: 20.10.2010
ROOM QUALIFICATION Review Date 20.10.2013
Page Page 12 of 19
Microbiology Culture Room
Section 5.0 Installation Qualification Procedure
Section 5.1 Unpacking
Unpack the Microbiological Equipment, Microscope etc with carefully and
Check other accessories. Keep Calibration certificate in a safe place.
Yes NO N/A
Section 5.2 Electric Connection
Make sure the power adapter matches your local power supply and operate
Orion Star with the supplied universal power supply only. Based on your power
source,select one of the four plugs provided and slide it into the grooves on the
adapter. A click will be heared when the plug is properly in place Connect the
outplug of the power supply to the power receptable on the benchtop meter.
Yes NO N/A
Section 5.3 Installing Tube Lights
Install the recommended Tube lights in the Room. Also install a emergency
Tube light which Operates In case Main Power Failure.
Yes NO N/A
Section 5.4 Installing Automated Temperature Probe
If using separate ATC probe for temperature measurement and automatic
temperature compensation install the temperature probe to the ATC 8 pin
socket.
Yes NO N/A
INSTALLATION QUALIFICATION IQ
Written By Reviewed By Approved By
Signature Signature Signature
& Date & Date & Date
Name Name Name
Title Title Title
BF Biosciences Limited Doc. No. QC-QD-007-00
Effective Date: 20.10.2010
ROOM QUALIFICATION Review Date 20.10.2013
Page Page 13 of 19
Microbiology Culture Room
Section 5.5 Power ON
Turn on the power using the ON/OFF key on the main unit. Display lights will
ON.
Yes NO N/A
Test result was successfully achieved: ______________________( YES / NO *)
Examiner:_____________ Date: _____________Signature:________________
Verified By: _____________ Date: _____________Signature:________________
Remarks(if any):
If test result “NO” then see Deviation sheet No.:______________
INSTALLATION QUALIFICATION IQ
6.0 DEVIATION
Written By Reviewed By Approved By
Signature Signature Signature
& Date & Date & Date
Name Name Name
Title Title Title
BF Biosciences Limited Doc. No. QC-QD-007-00
Effective Date: 20.10.2010
ROOM QUALIFICATION Review Date 20.10.2013
Page Page 14 of 19
Microbiology Culture Room
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
7.0 CONFORMANCE TO ACCEPTANCE CRITERIA
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
8.0 CONCLUSION
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
Written By Reviewed By Approved By
Signature Signature Signature
& Date & Date & Date
Name Name Name
Title Title Title
BF Biosciences Limited Doc. No. QC-QD-007-00
Effective Date: 20.10.2010
ROOM QUALIFICATION Review Date 20.10.2013
Page Page 15 of 19
Microbiology Culture Room
OPERATION QUALIFICATION OQ
Table of Content
SECTION DESCRIPTION PAGE
1.0 Objective 16
2.0 Responsibility 16
3.0 Action 17
4.0 Acceptance criteria 17
5.0 Room Identification 17
6.0 Operation Qualification Procedure 18
6.1 Power up test 18
6.2 Lighting check 18
6.3 Sound level check 18
6.4 HVAC grills check 18
6.5 Door Check 18
7.0 Deviation 19
8.0 Reason of acceptance 19
9.0 Conclusion 19
Written By Reviewed By Approved By
Signature Signature Signature
& Date & Date & Date
Name Name Name
Title Title Title
BF Biosciences Limited Doc. No. QC-QD-007-00
Effective Date: 20.10.2010
ROOM QUALIFICATION Review Date 20.10.2013
Page Page 16 of 19
Microbiology Culture Room
OPERATION QUALIFICATION OQ
Section 1.0 Objective:
The objective is to conform that all functions of the Microbiology Culture Room being
validated or tested with results recorded and YES/NO of all tests determined by
comparing results with pre-determined acceptance limits. The procedure certifies the
operation and also certifies the procedure to perform the test and operate with in limits.
Section 2.0 Responsibility:
Technical Validation Group (TVG)
- Writing of protocol
- Collection of data.
- Analysis of data.
- Execution of protocol.
Leader TVG
- Review of protocol execution and correction of data interpretation.
- Submission of executed protocol to CVG for Approval
Corporate Validation Group (CGV)
- Approval of protocol and its execution of validation exercise.
- Final Conclusion of validation and exercise Approval
Director Technical
For Authorization and
c) final conclusion approval
d) Approval of validation exercise.
Written By Reviewed By Approved By
Signature Signature Signature
& Date & Date & Date
Name Name Name
Title Title Title
BF Biosciences Limited Doc. No. QC-QD-007-00
Effective Date: 20.10.2010
ROOM QUALIFICATION Review Date 20.10.2013
Page Page 17 of 19
Microbiology Culture Room
OPERATION QUALIFICATION OQ
3.0 Action:
Compare the all equipment installation with the Drawings:
Check the Following:
− Power cables
− Check Air Grills
− Doors & its Locks
− Check Air Grills
− Internet cable
− Telephone Cable
− Walls Paint
− Roof Ceiling
4.0 Acceptance Criteria
− All installation should be According to the Design Qualification.
− All Electrical and others (internet & telephone Cables) Properly Installed and
In Sockets Gave Proper Output.
− All Room Lights Working Properly
− Check Air Grills
− Doors and its locks working properly
Section 5.0 Room Identification
ROOM NAME MICROBIOLOGY ROOM
ROOM NUMBER 104
LOCATION Quality Control
Written By Reviewed By Approved By
Signature Signature Signature
& Date & Date & Date
Name Name Name
Title Title Title
BF Biosciences Limited Doc. No. QC-QD-007-00
Effective Date: 20.10.2010
ROOM QUALIFICATION Review Date 20.10.2013
Page Page 18 of 19
Microbiology Culture Room
OPERATION QUALIFICATION OQ
Section 6.0 OPERATION QUALIFICATION PROCEDURE
6.1 POWER UP TEST
Performing the power up test make sure that the desired voltage is provided in
Sockets.
Yes NO N/A
6.2 LIGHTING
Tube lights controlling Button Working Properly. Light in Room is ≥ 300lux.
Yes NO N/A
6.3 SOUND
Make sure that Room is Free of Extra Noise. Check Sound Level ≤85dbs.
Yes NO N/A
6.4 HVAC GRILLS
Check HVAC grills Installed Properly.
Yes NO N/A
6.5 DOOR CHECK
Door and it lock working properly.
Yes NO N/A
Test result was successfully achieved: ______________________( YES / NO *)
Examiner:_____________ Date: _____________Signature:________________
Verified By: _____________ Date: _____________Signature:________________
Remarks(if any):
* If test result “NO” then see Deviation sheet No.:______________
Written By Reviewed By Approved By
Signature Signature Signature
& Date & Date & Date
Name Name Name
Title Title Title
BF Biosciences Limited Doc. No. QC-QD-007-00
Effective Date: 20.10.2010
ROOM QUALIFICATION Review Date 20.10.2013
Page Page 19 of 19
Microbiology Culture Room
OPERATION QUALIFICATION OQ
7.0 DEVIATION
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
8.0 CONFORMANCE TO ACCEPTANCE CRITERIA
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
9.0 CONCLUSION
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
Written By Reviewed By Approved By
Signature Signature Signature
& Date & Date & Date
Name Name Name
Title Title Title
