ZONEX PHARMA (PVT) LIMITED

Quality Assurance Department

Document Number ZP/QA/GEN/002
Version Number 00
STANDARD OPERATING Issue Date
Effective Date
24-4-2019
24-04-2019
PROCEDURE Review Date 24-04-2021
Supersedes N/A
Page Number 1 of 12
Title: CHANGE CONTROL

Original: Quality Assurance department

Copies: Quality Assurance department

Production department
Quality Control department Engineering
department
Warehouse department

1. OBJECTIVE
To define a procedure for handling the changes that may have potential impact on
product quality ensuring that quality of product is not compromised

2. REASON
2.1 To ensure that all planned changes which have the potential
to impact the quality of a material or product must be
controlled.
2.2 To ensure that changes are assessed and managed to
achieve the intended results.
2.3 To provide traceability of changes made throughout a product
and facility lifecycle.
2.4 To ensure that product quality is not adversely affected by a change.

3. SCOPE
This procedure is applicable to all changes that have the potential to
affect, product quality, safety, efficacy, stability, the validation status
of processes, facilities and systems.

Planned changes which require approval includes changes in:

3.1 Premises (Layouts)

3.2 Equipment (including Laboratory equipment).
 3.3 Utilities
3.4 Maintenance & Calibration routines/frequency
3.5 Products
3.6 Materials (Raw and Packaging)
3.7 Procedures and Processes
3.8 Documentation

This procedure excludes the following changes:

 Unplanned changes which are covered through deviation
handling procedure
 Changes involving replacement with identical parts

4. ROLES AND RESPONSIBILITIES

ROLE RESPONSIBILTIES
 To propose the change.
 To assess if the change is within scope of the
change control process.
Change initiator  To provide sufficient supporting information
required for initial assessment of the change.
 To submit the change control request for
assessment.
 To review and endorse change requests
prior to their submission for approval.
Relevant
Departmental  To manage the completion of the change control
manager plan, such as the implementation of the change
into routine use.

 To log the change control form.

 Classification and evaluation of change control.
 Verification of change control activities and
Quality Assurance implementation.
Department  Conduct the tanning on SOP and assure the
implementation
 Maintain the record of change control.
  Final authorization for implementation of the
change into routine use.
 Provide effective governance of the change
control process, ensuring change control
Head of Plant
procedures meet the requirements of this
Operations
change control process and all changes are
managed accordingly.
 Closeout change control form

5. PROCEDURE
5.1 DETAILS OF PROPOSED CHANGE
Initiation of Change Control
 Initiator will initiate the Change Control form. See Annexure-
II. The change control request must include as minimum:
 Proposed Change
 Reason for change
 Current status
 product systems affected
 Acceptance Criteria & target dates
 Impact of suggested change
 The proposed change is required to be endorsed by
Departmental Manager. If endorsement is not given then the
change request will not be forwarded to Quality Assurance
department for evaluation and approval.

5.2 Assessing the change

 The change control process can be triggered from a

variety of sources as listed in scope.
 The initiator is responsible for assessing whether the
proposed change is within the scope of the process.
 If there is any doubt that the proposed change is within the
scope of this SOP, the initiator and the Departmental
Manager must consult with the Head of Plant Operations
for advice.

5.3 Submission of Change Control

After getting approval from Department Manager initiator

will send the form to the Quality Assurance Manager.

5.4 Change Control Numbering

 The Change Control number will be given by the Quality
Assurance and each Change Control form will have
alphanumeric code as follows:

5.5 Evaluation of Change Control Panel

5.1.1 Change control panel will assess the details mentioned
under the proposed change.
5.2.1 QA manager will precede the evaluation process and
nominate the members of change control evaluation panel.

Change control panel will consist of:

 Head of Plant Operations
 Quality Assurance Manager
 Production Manager
 Quality Control Manager
 Engineering Manager(if required)
 Marketing director(if required)
 Finances manager(if required)
5.3.1 The change control panel according to their assessment
will decide that revalidation, stability studies and
requalification required or not.
5.4.1 QA manager will classify the change control on the bases
of assessment of the purposed change.

5.6 Categorization of change control

a. Major change: A change which may affect the critical
attributes of a system (product quality and process reliability)
is called a major change
 Addition or deletion of a step or addition of an alternative/
new step in the formulation manufacturing process.
 Change in the quantity of raw material or intermediate
used in the formulation of manufacturing process
 Change in the supplier of starting and packing material.
 Change to process parameters.

b. Minor change: A change that does not affect the critical

attributes of a system (product quality and process reliability) is
a minor change.
 Change in batch size.
 Change of cleaning agents for floors
  Replacement of apparatus part of same design.

5.7 Approval & Authorization

5.7.1 On the basis of assessment and recommendation of change

control panel the HOPO will make decision of approval or
rejection of proposed change.
5.7.2 Quality Assurance Manager will send the original form to the
Originator for implementation and photocopy of the form will
be retained with Quality Assurance Manager for follow up.
5.7.3 Any Validation batches of product, produced as supporting
evidence for the change, must be quarantined until the
receipt of required approvals.

5.8 Implementation of change

5.8.1 In case of the change rejected by HOPO change control will

be close and status will be updated in change control
trackers.
5.8.2 In case of approval by HOPO the change control form will
be returned to initiator to proceed further. Initiator
(departmental head ) will assign the duties/activities to
responsible person along with target dates
5.8.3 After completion of all activities the change control form will
be forwarded to QA Manger for verification of completion of
all activities. After getting the original authorized change
control form from Quality Assurance Manager, the initiator
will enter the date of implementation after implementing the
change.

5.9 Confirmation of Implementation Activities with Acceptance

Criteria

5.9.1 The departmental manager will ensure that the proposed

implementation activities have been completed with
acceptance criteria. If the acceptance criteria have been
met, then it will be endorsed by and Quality Assurance
Manager.
 5.10 Final Closure

After completion of all the actions, the initiator of Change

Control will update Change Control Documentation and
take approval from, head of plant operation signifying
completion of the review. The initiator will then hand
over the original Change Control Form to Quality
Assurance Manager for record and keep the photocopy
for their record.

5.11 CHANGE CONTROL TRACKERS

Quality Assurance Manager will update change control
tracker on monthly basis and present in Quality Council to
review the change controls open beyond the target
closure date. Format for Change Control Tracker is
attached as Annexure-III.

5.12 DOCUMENT FILING

The original documents are filed at Quality Assurance Manager
Office.
A copy of change control form is also the part of the Batch
Record / Dossier if related to product.

5.13 RETENTION PERIOD

Product specific change control will be retained for a
period of expiry of the product plus two year.
Facility related change control would be retained for lifetime.

6. ANNEXURES

Annexure I - Process Flow

Annexure II - Change Control Format
Annexure III - Change Control Tracker
 Annexure I
PROCESS FLOW MAP

Details of the
Proposed Change

Assessment by
Change Control
Panel

Evaluation of
proposed change

Approval and
Authorization

Confirmation of
Implemented
Activities

Final Closure
 ANNEXURE II

CHANGE CONTROL FORM

Change control no Date of logging

C C - /
(allotted by QA) (To be filled by QA)
Department of
Initiator of Request
Initiator
A- CHANGE CONTROL INITATION

Proposed Change

Reason

Current Status

Product system affected

Impact of suggested
change
Impact Assessment- Specify the following
Field Affected Yes No Comments

Does the change affect the validation status

Does the change affect stability studies

Does the documents need to change

Does the change affect dossier or other
regulatory document
Does the change affect product compliance

Does the change affect analytical method

Does the change require utilization of new
technology
Others

____________ _________ ____________ ______________ ______________ ______________ _____________

Initiator Name Date Sign. Designation Department Departmental Head QA Manager
 B- Evaluation Of Change (To be filled by QA)

Classification of Change:
Major Minor

C- Evaluation of proposed change (by change control panel)

Sr Brief description of his/her
Dept. Name/designation Initials
No assessments/recommendations

D- APPROVAL & AUTHORIZATION(to be filled by head of plant operation)

Signature of Head of Plant Operation: Date:

Approved Date Name Signature Recommendation

Approved

Rejected
 Remarks:

E- IMPLEMENTAION OF CHANGE

Activity Schedule (To be filled by department head)

Responsible Start Completion
Activity Dept. Initial
person Date Date

F-CONFORMATION OF IMPLEMENTATION ACTIVITIES

Date of implementation of change:

Remarks:

Initiator: Department Head: QA Manager:

 G- FINAL CLOSURES

Remarks:

QA Manager: Department Head:

 ANNEXURE III

CHANGE CONTROL TRACKER

Evidence Status
CC Actual
Initiation Propose Approval Closure of (Open
No Dept. Initiator Closure
Date d Change Date Date Closure or
. Date
Collected Closed)

Prepared By: Checked By:

Q.A Officer Q.A Manager

Date: Date: