SUN MOON PHARMACEUTICALS PVT. LTD.

Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtra -401 506.
STANDARD OPERATING PROCEDURE
TITLE:CHANGE CONTROL
Department : Quality Assurance SOP No. : SOP/QA/002
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 1 of 6
Prepared By Reviewed By Approved By
Sign. with
Date.

1.0 OBJECTIVE:

To lay down the procedure for affecting, monitoring and exercising control on the change(s) in the
facilities, equipment &instrumentation, utilities, manufacturing process at Sun Moon
Pharmaceuticals Pvt. Ltd.

2.0 SCOPE:

This procedure is applicable for Handling of Change Control at Sun Moon Pharmaceuticals Pvt. Ltd.

3.0 RESPONSIBILITY:

Dept. Head / Designee: Responsible for handling changes

Dept. Head / Designee: Review, training and implementation

Manager - QA / Designee: Approval and compliance

4.0 PRECAUTIONS:

NA

5.0 PROCEDURE:

5.1 Definition of Change Control:

Change control is a systematic approach to managing all changes made to a product or
system. The purpose is to ensure that no unnecessary changes are made, that all changes are
documented, that services are not unnecessarily disrupted and that resources are used
efficiently.

5.2 Types of Changes:

The changes are of two types.
Type-I: Temporary
Type-2: Permanent
Each one is explained as given
SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtra -401 506.
STANDARD OPERATING PROCEDURE
TITLE:CHANGE CONTROL
Department : Quality Assurance SOP No. : SOP/QA/002
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 2 of 6
Prepared By Reviewed By Approved By
Sign. with
Date.

5.2.1 Temporary change control:

It is a change proposed in the defined procedure for limited period of time. These
Changes are deliberately made arising due to unavoidable circumstances like

1. Breakdown of machineries.
2. Sudden accurate shortage of inputs (Raw materials).
3. Customer requirements with respect to Quality and batch size
4. Change in batch size for fixed number of batches.
5. Use of identical equipment for limited batches.
6. Change in non-critical raw and packing material vendor for limited supply.
7. Use of alternative analytical method (if validated)
8. Chromatographic columns of different brands

Note: Temporary change can become permanent change based on the request by
initiation department and after the assessment by Quality Assurance.

5.2.2 Permanent change control:

It is a change proposed in the defined procedure for improvement, by replacing the
existing procedure permanently.
E.g. Change in process, change in specifications, change in method of analysis,
change in equipment, change of site (location).

5.2.3 Based on the nature of effect on the quality of product changes are categorized as
1. Minor
2. Major

5.2.4 Minor Changes: Changes which are unlikely to have an impact on product quality are
termed as 'Minor' changes.

5.2.5 Major Changes: Changes which are likely to have an impact on 'Product
quality' or 'Safety' are termed as 'Major' changes.
SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtra -401 506.
STANDARD OPERATING PROCEDURE
TITLE:CHANGE CONTROL
Department : Quality Assurance SOP No. : SOP/QA/002
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 3 of 6
Prepared By Reviewed By Approved By
Sign. with
Date.

5.3 Initiation of Change:

5.3.1 Initiator who has to propose the change shall approach to Head – QA for issuance of
change control form as attached as per Annexure –I.

5.3.2 The QA shall allocate a unique sequential number to each CCF and maintain a
logbook as per Attachment-II.

5.3.2.1 The numbering format for change control form shall be as follow.

CCF: XXX/YY/ZZZ

Numbering shall begin with alphabets Change Control Form (CCF)

‘XX’ : Stands for department code (As listed in SOP on SOP)
‘YY’: Stands for two digit year code
‘ZZZ’: Stands for three digit numerical Change Control Form No. allocated in an
Incremental manner starting from 001
Example: QA/20/001

5.3.3 The concerned departmental officer / executive / Head shall initiate, by documenting
the changes control form.

5.3.4 The initiator shall record the justification for the proposed changes. All the relevant
data documents, which support the proposed changes, shall be attached along-with
the form.

5.3.5 The filled change control form shall be forwarded to QA through respective HOD
along with supporting data if any.
5.4 Review of Change:

5.4.1 QAreview change control form.

5.4.1.1 Classification of change Category as Minor or Major

5.4.1.2 Customer notification/Approval required.

SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtra -401 506.
STANDARD OPERATING PROCEDURE
TITLE:CHANGE CONTROL
Department : Quality Assurance SOP No. : SOP/QA/002
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 4 of 6
Prepared By Reviewed By Approved By
Sign. with
Date.

5.4.1.3 Calibration Required

5.4.1.4 Validation Qualification Required
5.4.1.5 Stability Studies required
5.4.1.6 Training Required.
5.4.1.7 Risk Assessment required.
5.4.1.8 A review change control form and if required shall send the proposed
change to other departments depending on the nature of change for
feedback.

5.4.1.9 Head of department/designee shall send back the change control form after
duly addressing the affect or requirement of proposed change, to Quality
assurance department.

5.4.1.10 Head QA/Designee review change assessment and Approved/ Not

Approved change.

5.5 Implementation of Change:

5.5.1.1 The changes shall be implemented by initiating department, after approval

of the CCF.

5.5.1.2 During implementation of the changes, necessary studies shall be carried

out & data shall be collected, as recommended in the CCF

5.5.1.3 The data generated shall be compiled by the initiating department and
forwarded to QA.

5.5.1.4 QA shall review other documents which may have to be updated due to the
change and ensure the updating of the same.

5.5.1.5 QA shall maintain the complete record of changes.

5.6 Closure of Change:

SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtra -401 506.
STANDARD OPERATING PROCEDURE
TITLE:CHANGE CONTROL
Department : Quality Assurance SOP No. : SOP/QA/002
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 5 of 6
Prepared By Reviewed By Approved By
Sign. with
Date.

5.6.1.1 The closure of the change control initiation form shall be responsibility of
the Initiator dept. head & QA head. QA shall verify whether the
recommendations made in the Change Control Form, have been
implemented.

5.6.1.2 The Head QA/Designee shall together review the data generated during the
implementation of the change control.

5.6.1.3 Finally, head-QA shall sign the closure of the change control form. The
closure of the change control form shall also be recorded in the logbook as
per Annexure-II.

6.0 LIST OF ANNEXURES / ATTACHMENTS:

ANNEXURE – 1 Change Control Form (CCF) SOP/QA/002-F01.00

Specimen Format of Change Control Log
ANNEXURE – 2 SOP/QA/002-F02.00
Book

7.0 ABBREVIATIONS:

SOP Standard operating procedure

No. Number
NA Not Applicable
REV. Revision
QA Quality Assurance
PD Process &Development
Dept. Department
CCF Change Control Form

8.0 REFERENCE

SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtra -401 506.
STANDARD OPERATING PROCEDURE
TITLE:CHANGE CONTROL
Department : Quality Assurance SOP No. : SOP/QA/002
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 6 of 6
Prepared By Reviewed By Approved By
Sign. with
Date.

ICHQ7

9.0 SOP DISTRIBUTION:

Name of Department Department Code

Quality Assurance QA
Production PD
Quality Control QC
Microbiology MB
Maintenance & Engineering MD
Human resources HR
Warehouse WH

10.0 REVISION AND HISTORY:

REV. NO. REASON FOR REVISION

00 New SOP

SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization