BF Biosciences Limited Doc. No.

QC-QD-XX-XX
Effective Date: DD..MM.YYYY

VALIDATION DOCUMENT Review Date DD..MM.YYYY

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FINISH GOODS COLD ROOM

DESIGN QUALIFICATION DQ

Signatu
Name Designation
and da

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-XX-XX
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DESIGN QUALIFICATION DQ

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-XX-XX
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VALIDATION DOCUMENT Review Date DD..MM.YYYY

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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-XX-XX
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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-XX-XX
Effective Date: DD..MM.YYYY

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DESIGN QUALIFICATION DQ

TABLE OF CONTENT

Section Description Page No.

1. General Description 3

2. Design Qualification Protocol Approval 4

3. Introduction 5

4. Objective 5

5. Scope 5

6. Acceptance Criteria 5

7. Procedure 5

Attachment 7
8.
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Section 1.0 Introduction:
Design qualification is the documented evidence that the system has been designed correctly
as per URS and good engineering practices.

This Design Qualification protocol is used to verify the Design of [equipment/ system/project
name] system as per URS, located in BF Biosciences ltd

Section 2.0 Objective:

The objective of this protocol is to establish the documented evidence that all key aspects of
the system are in compliance with agreed specifications and all fabrication and manufacturing
will be done to meet the required specifications mentioned in the URS.

Section 3.0 Scope:

The scope of this procedure is to evaluate the following but not limited to these:
Design of Instrument/equipment/System as per requirements.
All relevant documents are supplied with design
Note: Design qualification is limited to the design of system components and attached
components and does not include Design of any support utilities, other than connections at the
system boundary.
Section 4.0 Responsibility:

Technical Validation Group (TVG)

- Preparation of DQ protocol in the light of URS

-
Team Leader Technical Validation Group

- Ensuring that valid SOP for handling the instrument available.

- Reviewing and approving DQ protocol and report.
Corporate Validation Group (CVG)

- Reviewing Qualification protocol and report

- Preparation of DQ protocol and obtaining approval
- Collecting data and generating DQ report
- Identifying requirements
Director Technical:- For authorization of protocol.
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Section 5.0 Equipment/Instrument/System Description:

Finish Goods Products Cold room Should be As per given below Detail:

 Store Size :6000Х4000Х4500mm

 6 Hp semi hermetic Air cooled Condensing unit
 Suitable for maintain temp:-+ 2°C ~ + 8C
 Door size :900Х1900Х100mm(thick)
 Flooring single layer of 50 mm P.U.Board
 Electric panel are should be as per drawing

Section 6.0 Acceptance Criteria

The acceptance criteria will depends on the certification that the Design of the room is in
compliance with the requirements of this protocol (as minimum or exceeds the requirements).

Section 5.0 Procedure

The design of equipment/instrument/system will be qualified by designed calculations,

evaluation through URS and confirmation of that the design confirms to establish specifications

and documents. If there is any deviation is observed will be reported on the deviation form.

The key specs of DQ are as follows:

7.1 Development of URS:

Specifications / requirements of the user group will establish the criteria of URS for the

equipment/instrument/system. The requirements / specifications of user group are as:

7.1.1 Requirements of Local Regulatory (MOH)

7.1.2 Requirements of Quality

7.1.3 Requirements of Engineering

7.1.4 General requirements

7.2 Design Brief

The consultant / vendor/supplier will design/ provide the

equipment/instrument/system on the basis of URS and drawing / layout

provided and will submit the design for approval. Followings are the key steps
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according to which the consultant/ supplier will submit the design / specs for

review and approval.

7.2.1 Description.
7.2.2 Specifications.
7.2.3 Drawing / layout.

7.3 Design Review:

The consultant / vendor will submit the design for review. After the review and

approval of design, the consultant / vendor will provide the following details:

Final drawings / layouts specifications

7.4 Design Summary Report:

The Design Summary Report will be generated after the qualifying the Design

of Finish Product cold Room.

7.5 Deviation Report:

If any deviation is observed, will be recorded in the deviation report (see Annexure 7).

The corrective action will also be recommended in the deviation report.

8. Attachments:

Annex 1: Drawing of Finish Product Cold Room

Annex 2: Operation Requirements Copy
Annex 3: BOQ
Annex 4: Purchase Order
Annex 5: Contract between BF and vendor
Annex 6: Warranty Certificate
Annex 7: Deviation