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 manufacturing and storage vessels in liquid manufacturing area of Citi
Naturals Limited for the manufacturing of liquid dosage form.
S.S Manufacturing tank: 01
Storage Tank: 01
Double Jacketed Manufacturing Tank: 01
Purified Water Storage Tank:01
Silverson Mixer with Tank: 01

Reason for Change:

To meet the requirement of new plant to maintain and sustain the liquid dosage form.

Products in Scope:

Liquid value stream products to be manufactured in liquid value stream.

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
URS must be Asad Ali,
Development of the URS of the
approved as per
storage vessels to be installed Mobeen Akbar
acceptance criteria.
Asad Ali
Performance of Design DQ must be approved Mobeen Akbar,
Qualifications of the storage as per URS &
Abdullah
vessels. acceptance criteria
Farooq
Asad Ali
IQ must be approved Mobeen Akbar,
Installation Qualifications of the
as per acceptance
storage vessels. Abdullah
criteria.
Farooq

SOPs development for the As per SOP for SOP

Asad Ali
maintenance and operation of and other functions for
manufacturing and storage Mobeen Akbar,
as per applicable
vessels before normal working Ahsan Bhatti
of the production line. guidelines.
Training must impart Asad Ali
Training of Staff on approved adequate Mobeen Akbar,
SOPs. understanding and
must be evaluated.
Master List of Equipment of the Must be updated as
facility would be updated to per existing Mobeen Akbar,
incorporate storage and
manufacturing vessels equipment.
Asad Ali
must be approved as Mobeen Akbar,
Operational Qualifications of
per acceptance
the equipment. Abdullah
criteria.
Farooq
Performance Qualifications of must be approved as Asad Ali
the equipment. 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

Post Implementation Review required? Yes No

Activity Owner Target Date Comments

Preventive Maintenance of
storage vessel of liquid
value stream to be Engineering Incharge
incorporated in the Annual
Preventive 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.

Impact related to Quality of Product

Impact on cosmetic quality.

 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 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
Mr. Sajjad Hussain
Manager Quality Control
Mr. Ali Raza
 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

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: __________________________