Document #: QA/FOR/FMT-016

CITI PHARMA LIMITED Version #: 03

Issue Date: 27th August 2021
TITLE: Effective Date: 31st August 2021
CHANGE CONTROL FORM No. of Pages : Page 1 of 5

Change Control #:
Date of Raising Change 01st October 2021
Change Initiator Mr. Asad Ali (Project Engineer)
Department Engineering
Type of Change: Permanent Temporary
Proposed Implementation Date 30th September 2022

Section A: Planned Change Initiation

Description of Change:
To install air handling units (AHUs) at Citi Naturals Limited (03 KM, Head Balloki
Road, Phool Nagar District Kasur) to maintain the condition of the area for the
production of Nutraceutical products.
Total 07 AHU Units.
Reason for Change:

To meet the requirement of new plant to maintain the environment for the production
of Nutraceutical products.

Products in Scope:

GSK Consumer liquid dosage form is going to be manufacture in liquid value

stream are in scope of this change control.

Name Mr. Asad Ali

(Change Requester) Project Engineer

Name Mr. Mobeen Akbar

(Area/Process Owner) Manager Production

Name Ms. Khansa Rustam

(Quality representative) Head of Quality Operations
 Document #: QA/FOR/FMT-016
CITI PHARMA LIMITED Version #: 03
Issue Date: 27th August 2021
TITLE: Effective Date: 31st August 2021
CHANGE CONTROL FORM No. of Pages : Page 2 of 5

Packaging Component Process / Technical

Facilities Batch Size

Change Type Raw Material Other. Specify:

Quality
Equipment

Section B: Proposed Implementation Activities with Action Plan (To be completed by

Originator)

Activities (List of Acceptance Target

Owner Status
Documents or working) Criteria Date
Development of the URS of the URS must be Asad Ali,
air handling units to be approved as per
Mobeen Akbar
installed acceptance criteria.
Asad Ali
Performance of Design DQ must be approved Mobeen Akbar,
Qualifications of air handling as per URS &
Abdullah
units acceptance criteria
Farooq
Asad Ali
IQ must be approved Mobeen Akbar,
Installation Qualifications of the
as per acceptance
AHUs. Abdullah
criteria.
Farooq
As per SOP for SOP
Asad Ali
Operational Qualifications of and other functions for
Mobeen Akbar,
the AHUs. as per applicable
Ahsan Bhatti
guidelines.
SOPs development for the Training must impart Asad Ali
maintenance and operation of adequate Mobeen Akbar,
AHUs before normal working understanding and
of the production line. must be evaluated.
Must be updated as
Training of Staff on approved per existing Mobeen Akbar,
SOPs.
equipment.
Asad Ali
Master List of Equipment of the
must be approved as Mobeen Akbar,
facility and Master list of SOPs
per acceptance
would be updated to Abdullah
criteria.
incorporate AHUs. Farooq
Performance Qualifications of must be approved as Asad Ali
the AHUs. per acceptance
 Document #: QA/FOR/FMT-016
CITI PHARMA LIMITED Version #: 03
Issue Date: 27th August 2021
TITLE: Effective Date: 31st August 2021
CHANGE CONTROL FORM No. of Pages : Page 3 of 5

Activities (List of Acceptance Target

Owner Status
Documents or working) Criteria Date
Mobeen Akbar,
criteria. Abdullah
Farooq

Asad Ali,
Mobeen Akbar,
Performance of Thermal URS must be Mr.Sajjad
Mapping of raw material and approved as per
Husssin,
Finished Goods warehouse acceptance criteria.
Abdullah
Farooq

Post Implementation Review required? Yes No

Activity Owner Target Date Comments

Preventive Maintenance of
AHUs to be incorporated in
the Annual Preventive Engineering Incharge
Maintenance Plan of the
facility
Self-Inspection/Internal
Auditing to check the Quality Assurance
effectiveness of Manager
implemented changes.

Section C: Assessment of Change

INITIAL IMPACT ASSESSMENT (Responsibility: Department Manager)

If yes take actions (Remedial, Corrective, Preventive actions) accordingly: Yes No

Impact on any batch (es) immediately affected.

If Yes record batch #

Impact on any batch (es), which may be affected.

If Yes record batch #

Current status of any implicated batches.

Impact related to Regulatory Compliance.

 Document #: QA/FOR/FMT-016
CITI PHARMA LIMITED Version #: 03
Issue Date: 27th August 2021
TITLE: Effective Date: 31st August 2021
CHANGE CONTROL FORM No. of Pages : Page 4 of 5

Impact related to Quality of Product

Impact on cosmetic quality.

Impact related to primary packaging components.

Impact related to Secondary Packaging components.

Impact related to Artwork

Impact related to Microbiological risk

Impact related to Any cross-contamination risk

Impact on raw material

Impact Related to Process Flow

Impact Related to Personnel Flow

Impact Assessment related to EHS required

Any Adverse Health, Safety and Environment impact

Change Control Panel

Name & Designation Signature & Date
Head of Quality Operations
Ms. Khansa Rustam
Production Manager
Mr. Mobeen Akbar
QA Manager
Mr. Abdullah Farooq
Engineering Manager
Mr. Ahsan Bhatti
Regulatory Affairs Manager
Mr. Sohail Khan

Manager Supply Chain

 Document #: QA/FOR/FMT-016
CITI PHARMA LIMITED Version #: 03
Issue Date: 27th August 2021
TITLE: Effective Date: 31st August 2021
CHANGE CONTROL FORM No. of Pages : Page 5 of 5

Mr. Sajjad Hussain

Manager Quality Control
Mr. Ali Raza

Section D: Approval for Implementation

All requirements for the implementation of this change have now been met. The process of
change control can be initiated.
Approved Rejected

Originator: ______________________ QA Manager: _____________________

Date: ___________________________ Date: __________________________

Section E: Authorization
The proposed change is authorized for implementation.
Yes No
____________________
Head of Quality Operations
Section F : Implementation Date and Information to all Stake holders (Originator will
complete this)
Date of Implementation:
Confirm that all Stake Holder informed □ Yes □ No

Name & Signature

Section G : Post Implementation Activities (Originator will complete this)

Is requirement of Post Implementation Activities completed □ Completed

Originator Name
Sign & Date
Section H : Change Close Out

CLOSED  NOT CLOSED 

All actions required are completed. Therefore, the change can be considered as closed.

Originator: ______________________ QA Manager: _____________________

Date: ___________________________ Date: __________________________