Document Name: Change Managment in automated QMS Software

Document Number: CQA-CP-GEN-006

Version: 0.0.3.0 Eff date: 28-Mar-2011

STANDARD OPERATING PROCEDURE

CATEGORY : GENERAL PROCEDURE

TITLE : CHANGE MANAGEMENT IN AUTOMATED QUALITY MANAGEMENT
SYSTEM SOFTWARE
DEPARTMENT : CORPORATE QUALITY ASSURANCE

1 OBJECTIVE
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To lay down a procedure for initiation, evaluation, approval/rejection and implementation of changes using Automated
Quality Management System Software.

2 SCOPE
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This SOP is applicable for managing a change in the Standard Operating Procedures, Raw Materials, Packing
Materials, Drug Product, Manufacturing Process, Analytical Methods, Specifications, Equipment, Utilities , Quality
System and other documents using Automated Quality Management System Software.

3 RESPONSIBILITY
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3.1 Assistant /Executive of the concerned department (Change Initiator) - shall be responsible to initiate a
change in the Automated Quality Management System software
3.2 Head of the respective department/Section In charge (Change Owner) - shall be responsible for the
evaluation, justification of the requested change and for documenting the results after implementation
of the change.
3.3 Concerned QA In charge (QA Reviewer) -shall be the Change Control Co-ordinator responsible to
3.3.1 Route the change request for cross-functional review (Functional review, Regulatory Affairs
review, CG/QP review), if required.
3.3.2 Approve/void minor change requests.
3.3.3 Request CAB for authorization of major and moderate change requests.
3.3.4 Verify and approve the implementation of change action items.
3.3.5 Close-out of the change.
3.4 Cross functional department head/ Designee (Functional Reviewer) - shall be responsible to carry out
impact analysis for the proposed change and create action items for implementing the change.
3.5 Regulatory Affairs In-charge / Designee (Regulatory Reviewer) - shall be responsible to evaluate the
impact of the proposed change on regulatory commitment and create action items, wherever
applicable.
3.6 Authorized Representative of the Contract Giver or the Qualified Person (CG/QP Reviewer) - shall be
responsible to
3.6.1 Evaluate the impact of the proposed change on Regulatory Commitment,
3.6.2 Create action items and approve/recommend void the change request, wherever applicable.
3.7 Customer Technical Support (CTS)- shall be responsible to perform the activities on behalf of CG/QP,
if system access is not available to the CG/QP

Page 1 of 31
¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾
CORPORATE QUALITY ASSURANCE, AUROBINDO PHARMA LIMITED, 313 & 314, BACHUPALLY, QUTHUBULLAPUR, RR DISTRICT, HYDERABAD - 500090
SIGNATURES DURING APPROVAL User: CH Sesh Kumar
Authorized by A.R.M. RAO on 22-Mar-2011 Timestamp: 25-Mar-2011
Approved by Dr.Tushar Desai on 21-Mar-2011 Copy number: 3
Authored by ANSHUMAN SARAN on 21-Mar-2011
Document Name: Change Managment in automated QMS Software
Document Number: CQA-CP-GEN-006
Version: 0.0.3.0 Eff date: 28-Mar-2011

STANDARD OPERATING PROCEDURE

CATEGORY : GENERAL PROCEDURE

TITLE : CHANGE MANAGEMENT IN AUTOMATED QUALITY MANAGEMENT
SYSTEM SOFTWARE
DEPARTMENT : CORPORATE QUALITY ASSURANCE

3.8 Senior Management Representative - Corporate Quality Assurance Head or Authorized Deputy, (CAB
Reviewer) - shall be responsible to evaluate and approve/recommend void major and moderate change
requests.

4 PROCEDURE
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4.1 Change Management procedure shall be followed if any of the following changes are required, but not
limited to,
4.1.1 Change(s) requesting an additional or alternate source of raw materials and packaging
materials
4.1.2 Change(s) in manufacturing procedures
4.1.3 Change (s) in product colour, shape and size
4.1.4 Change (s) in packaging and labelling
4.1.5 Change(s) to process and/or testing equipment/critical spares
4.1.6 Change(s) to raw material or supplier
4.1.7 Change(s) to validated cleaning methods and processes
4.1.8 Change(s) to Master Production / Packaging Records
4.1.9 Change(s) to approved procedures like SOP, Specifications, STP and GTP.
4.1.10 Change(s) to calibration tolerances or frequency of calibration
4.1.11 Change(s) to qualified facility or utilities.
4.1.12 Change(s) to computer systems.
Note:
F This procedure is applicable only for the planned changes.
F This procedure is not applicable to routine breakdowns, Calibration and planned Preventive
Maintenance activities.

4.2 Change(s) is of two types:

4.2.1 Temporary: Change proposed for a specific period of time/ specific number of batches. If the
outcome of the change is satisfactory/ as intended, this change can be made permanent or may revert
back to the existing procedure.

Eg: Manual packing shall be carried out for a campaign (of 5 batches) since the Auto cartonator is
not working.

4.2.2 Permanent: Change proposed forever as a part of advancement in technology or as a part of

continuous improvement or to be in line with regulatory updation. The existing procedure/system shall
become invalid after implementation of this type of change.

Page 2 of 31
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CORPORATE QUALITY ASSURANCE, AUROBINDO PHARMA LIMITED, 313 & 314, BACHUPALLY, QUTHUBULLAPUR, RR DISTRICT, HYDERABAD - 500090
SIGNATURES DURING APPROVAL User: CH Sesh Kumar
Authorized by A.R.M. RAO on 22-Mar-2011 Timestamp: 25-Mar-2011
Approved by Dr.Tushar Desai on 21-Mar-2011 Copy number: 3
Authored by ANSHUMAN SARAN on 21-Mar-2011
Document Name: Change Managment in automated QMS Software
Document Number: CQA-CP-GEN-006
Version: 0.0.3.0 Eff date: 28-Mar-2011

STANDARD OPERATING PROCEDURE

CATEGORY : GENERAL PROCEDURE

TITLE : CHANGE MANAGEMENT IN AUTOMATED QUALITY MANAGEMENT
SYSTEM SOFTWARE
DEPARTMENT : CORPORATE QUALITY ASSURANCE

4.3 Change (s) shall be categorized as given below

4.3.1 Major:
4.3.1.1 Major changes are those that are likely to have a significant impact on the system
and/or product quality and performance.
4.3.1.2 This type of change has a substantial potential to have an adverse effect on the
identity, quality, strength, purity or potency of a drug product as these factors
may relate to the safety or effectiveness of the drug product.
Eg: Changes in the components or composition of the drug product, etc.
4.3.1.3 This type of changes may require approval from the Regulatory Affairs
4.3.2 Moderate:
4.3.2.1 Moderate changes are those that could have a significant impact on the system
and/or product quality and performance.
4.3.2.2 This type of change has a moderate potential to have an adverse effect on the
identity, quality, strength, purity or potency of a drug product as these factors
may relate to the safety or effectiveness of the drug product.
Eg: Change in the technical grade of the excipient (Avicel PH102 vs Avicel
PH200), Change in Artwork which requires notification to regulatory agency, etc.
4.3.2.3 This type of changes may require notification to the Regulatory Affairs.
4.3.3 Minor:
4.3.3.1 Minor changes are those that are unlikely to have any detectable impact on the
system and/or product quality and performance.
4.3.3.2 This type of change has a minimal potential to have an adverse effect on the
identity, quality, strength, purity or potency of a drug product as these factors
may relate to the safety or effectiveness of the Drug Product.
Eg: Deletion or partial deletion of an ingredient intended to affect the colour or
flavour of the drug product or change in the ingredient of the printing ink to
another approved agent, etc.
4.4 Whenever a change in necessary/desirable, the concerned Assistant / Executive shall initiate the
Change Request.
4.5 Department In charge (Change Owner) shall assess the impact of change on the existing
system/procedure and provide scientific rationale, if any.
4.6 If the change is not acceptable, change owner shall recommend void/reject the proposed change.
4.7 Based on the category and nature of change, the Change control coordinator shall identify the Cross
functional reviewer/Regulatory affairs reviewer, if applicable to review/evaluate and approve the
proposed change.

Page 3 of 31
¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾
CORPORATE QUALITY ASSURANCE, AUROBINDO PHARMA LIMITED, 313 & 314, BACHUPALLY, QUTHUBULLAPUR, RR DISTRICT, HYDERABAD - 500090
SIGNATURES DURING APPROVAL User: CH Sesh Kumar
Authorized by A.R.M. RAO on 22-Mar-2011 Timestamp: 25-Mar-2011
Approved by Dr.Tushar Desai on 21-Mar-2011 Copy number: 3
Authored by ANSHUMAN SARAN on 21-Mar-2011
Document Name: Change Managment in automated QMS Software
Document Number: CQA-CP-GEN-006
Version: 0.0.3.0 Eff date: 28-Mar-2011

STANDARD OPERATING PROCEDURE

CATEGORY : GENERAL PROCEDURE

TITLE : CHANGE MANAGEMENT IN AUTOMATED QUALITY MANAGEMENT
SYSTEM SOFTWARE
DEPARTMENT : CORPORATE QUALITY ASSURANCE

4.8 In case the proposed change is related to contract manufacturing product, the change request shall be
forwarded to Contract Giver/Qualified Person of the Marketing authorization Holder for
approval/rejection as per the requirements in the Quality / Technical agreement.
4.9 QA In charge shall finally review the change request based on the comments from the cross functional
reviewer/ RA/CG/QP (wherever applicable) and approve/ reject the minor change.
4.10 Major and Moderate change requests shall be forwarded to CAB reviewer for approval/ rejection.
4.11 On approval of change request, the change shall be implemented by the respective personnel.
4.12 Concerned Department In-Charge shall evaluate the effectiveness of change.
4.13 Change Control coordinator shall review and close the change, if the change implemented is found
satisfactory.
4.14 In case the change request is rejected, the same shall be intimated to the concerned Department In-
Charge.
4.15 Change Management flow chart is enclosed as Format-1.

MANAGEMENT OF CHANGE(S) USING AUTOMATED QUALITY MANAGEMENT SYSTEM

SOFTWARE:
4.16 The process of initiation, assessment, approval/rejection, implementation and close out of the change
shall be handled using Change Control Module of the automated Quality Management System
Software as described below.
4.17 The Change Control Module shall cover the following functionalities:
4.17.1 Initiate Change Request.
4.17.2 Change Owner’s Review.
4.17.3 QA Review of Change Request.
4.17.4 Functional Assessment of Change Request.
4.17.5 QA Functional Review Approval.
4.17.6 Regulatory Review of Change Request.
4.17.7 CG/QP Review of Change Request.
4.17.8 QA Final Review.
4.17.9 CAB Approval of Change Request.
4.17.10 Pre-Implementation Action Items Execution/ Implementation Action Items Execution /
Follow-Up Action Items Execution.
4.17.11 Pre-Implementation Action Items Approval/ Implementation Action Items Approval /
Follow-Up Action Items Approval.
4.17.12 QA Review of Pre-Implementation Action Items/ QA Review Of Implementation Action
Items/ QA Review of Follow up Action Items.
4.17.13 Document First Results by Change owner.
Page 4 of 31
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CORPORATE QUALITY ASSURANCE, AUROBINDO PHARMA LIMITED, 313 & 314, BACHUPALLY, QUTHUBULLAPUR, RR DISTRICT, HYDERABAD - 500090
SIGNATURES DURING APPROVAL User: CH Sesh Kumar
Authorized by A.R.M. RAO on 22-Mar-2011 Timestamp: 25-Mar-2011
Approved by Dr.Tushar Desai on 21-Mar-2011 Copy number: 3
Authored by ANSHUMAN SARAN on 21-Mar-2011
Document Name: Change Managment in automated QMS Software
Document Number: CQA-CP-GEN-006
Version: 0.0.3.0 Eff date: 28-Mar-2011

STANDARD OPERATING PROCEDURE

CATEGORY : GENERAL PROCEDURE

TITLE : CHANGE MANAGEMENT IN AUTOMATED QUALITY MANAGEMENT
SYSTEM SOFTWARE
DEPARTMENT : CORPORATE QUALITY ASSURANCE

4.17.14 Change close out by Change Control Coordinator.

4.18 Initiating a Change request

4.18.1 Switch on the computer and enter the network using the corresponding network password.
4.18.2 Click on the Internet Explorer icon and look for the address in the address bar as
“http://qms-aurobindo” or else type the same in the address bar.
4.18.3 Quality Management System welcome screen shall appear. Click on the Login button.
Quality Management System Login screen shall appear.
4.18.4 Type the User name and password and click Log in. Log in home page shall appear.
4.18.5 Initiate the change request from Change Initiator infocenter by clicking Initiate Change
Request form as shown. Change request form is enclosed as Format-2.

4.18.6 Fill all the relevant fields in the Initiate Change Request form.
4.18.6.1 Appropriate Organization Level and Organization Name shall be selected.
4.18.6.2 Appropriate Change source and Change source reference ID, wherever
applicable shall be selected. Customer/Market/License Number shall be recorded
4.18.6.3 Change Details Section
4.18.6.3.1 Detailed information about the change shall be recorded in the
Change Description field.
4.18.6.3.2 Under the Type of Change field, select Temporary or Permanent
based on the change proposal
4.18.6.3.3 Select Product Status, if the proposed change has direct or indirect
affect on the Drug Product for which change is proposed. Product
status shall be as follows:
4.18.6.3.3.1 Prior approval: Change proposed before or during the
regulatory approval of the product.
4.18.6.3.3.2 Post approval: Change proposed for product that is
approved by Regulatory Authority.
4.18.6.3.3.3 Not Applicable: Change proposal which does not
impact the product.

Page 5 of 31
¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾
CORPORATE QUALITY ASSURANCE, AUROBINDO PHARMA LIMITED, 313 & 314, BACHUPALLY, QUTHUBULLAPUR, RR DISTRICT, HYDERABAD - 500090
SIGNATURES DURING APPROVAL User: CH Sesh Kumar
Authorized by A.R.M. RAO on 22-Mar-2011 Timestamp: 25-Mar-2011
Approved by Dr.Tushar Desai on 21-Mar-2011 Copy number: 3
Authored by ANSHUMAN SARAN on 21-Mar-2011
Document Name: Change Managment in automated QMS Software
Document Number: CQA-CP-GEN-006
Version: 0.0.3.0 Eff date: 28-Mar-2011

STANDARD OPERATING PROCEDURE

CATEGORY : GENERAL PROCEDURE

TITLE : CHANGE MANAGEMENT IN AUTOMATED QUALITY MANAGEMENT
SYSTEM SOFTWARE
DEPARTMENT : CORPORATE QUALITY ASSURANCE

4.18.6.3.4 Classify the change based on the priority and criticality from the list of
 values (LOV) as
4.18.6.3.4.1 Emergency-Major
4.18.6.3.4.2 Emergency-Moderate
4.18.6.3.4.3 Emergency-Minor
4.18.6.3.4.4 Normal-Major
4.18.6.3.4.5 Normal- Moderate
4.18.6.3.4.6 Normal- Minor
Note
F Emergency : The change request which requires immediate
attention / priority
F Normal: The change request which may not require immediate
attention.
4.18.6.3.5 The probable date of implementation shall be proposed under Target
Effective Date.
4.18.6.3.6 The name of the Product/Material affected with respect to the change
shall be selected under the Impact section as Products impacted, if any.
4.18.6.3.7 Other impact, if any shall be selected from the following,
4.18.6.3.7.1 Automated systems
4.18.6.3.7.2 Documents
4.18.6.3.7.3 Equipment
4.18.6.3.7.4 Facility
4.18.6.3.7.5 Utility
4.18.6.3.7.6 No impact
4.18.6.3.8 Similar change request(s), if any, shall be selected under the Related
Changes and associated with the current change.
4.18.6.4 Change Line Items
4.18.6.4.1 Detailed information about the Existing and Proposed
procedure/system/ shall be recorded under the change line items
section with appropriate justification.
4.18.6.4.2 Change Item Category and Item Subcategory shall be selected as per
the table given.

Category Sub Category Item Additional Details

Page 6 of 31
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CORPORATE QUALITY ASSURANCE, AUROBINDO PHARMA LIMITED, 313 & 314, BACHUPALLY, QUTHUBULLAPUR, RR DISTRICT, HYDERABAD - 500090
SIGNATURES DURING APPROVAL User: CH Sesh Kumar
Authorized by A.R.M. RAO on 22-Mar-2011 Timestamp: 25-Mar-2011
Approved by Dr.Tushar Desai on 21-Mar-2011 Copy number: 3
Authored by ANSHUMAN SARAN on 21-Mar-2011
Document Name: Change Managment in automated QMS Software
Document Number: CQA-CP-GEN-006
Version: 0.0.3.0 Eff date: 28-Mar-2011

STANDARD OPERATING PROCEDURE

CATEGORY : GENERAL PROCEDURE

TITLE : CHANGE MANAGEMENT IN AUTOMATED QUALITY MANAGEMENT
SYSTEM SOFTWARE
DEPARTMENT : CORPORATE QUALITY ASSURANCE

Category Sub Category Item Additional Details

Document No.
Standard Operating Procedures.
Document Name
Document No.

Master Formula Card /Master Packaging Card / Batch Processing Document Name
Record / Batch Packaging Record Product Code
Product Name
Document No.
Documents
Document Name
Product Code
Standard Test Procedure.
Product Name
Material Code
Material Name

General Test Procedure / Site Master File / Validation Master Plan / Document No.
Quality Manual / Organogram Document Name
Document No.
Document Name
Artwork
Material Code
Packaging
Material Name
Document No.
Layout
Document Name

Batch size / Manufacturing Process / Product Code

Process
Site Change / Process Equipment Product Name
Material Code
Material Manufacturer/ Supplier
Material Name
Document No.
Document Name
Specification API / Packaging component
Material Code
Material Name

Page 7 of 31
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CORPORATE QUALITY ASSURANCE, AUROBINDO PHARMA LIMITED, 313 & 314, BACHUPALLY, QUTHUBULLAPUR, RR DISTRICT, HYDERABAD - 500090
SIGNATURES DURING APPROVAL User: CH Sesh Kumar
Authorized by A.R.M. RAO on 22-Mar-2011 Timestamp: 25-Mar-2011
Approved by Dr.Tushar Desai on 21-Mar-2011 Copy number: 3
Authored by ANSHUMAN SARAN on 21-Mar-2011
Document Name: Change Managment in automated QMS Software
Document Number: CQA-CP-GEN-006
Version: 0.0.3.0 Eff date: 28-Mar-2011

STANDARD OPERATING PROCEDURE

CATEGORY : GENERAL PROCEDURE

TITLE : CHANGE MANAGEMENT IN AUTOMATED QUALITY MANAGEMENT
SYSTEM SOFTWARE
DEPARTMENT : CORPORATE QUALITY ASSURANCE

Category Sub Category Item Additional Details

Document No.

In process / Document Name

Finished Product Product Code
Product Name
Facility Location
Equipment Name
Engineering Equipment Identification No.
Engineering Location
Utility Name
Utility Identification No.
Location
Hardware Name
Manufacturer Name
Hardware
Identification No.

Automated Location
systems Software Name
Manufacturer Name
Software
Version No.
Location
4.18.6.4.3 Item additional details shall appear with respect to the Item
Category and Item Subcategory as mentioned in the above table.
Record Item additional details appropriately.
4.18.6.4.4 Item Justification from the list of available LOV shall be selected or
the appropriate item justification shall be recorded.
4.18.6.4.5 Comments & Attachments
4.18.6.4.5.1 Additional comments, if any, with respect to the
proposed change shall be recorded.
4.18.6.4.5.2 Risk Assessment wherever applicable shall be attached
in the Attachments section,
4.18.6.4.5.3 Supporting documents or photographs if any shall be
attached in the Attachments section.
Page 8 of 31
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CORPORATE QUALITY ASSURANCE, AUROBINDO PHARMA LIMITED, 313 & 314, BACHUPALLY, QUTHUBULLAPUR, RR DISTRICT, HYDERABAD - 500090
SIGNATURES DURING APPROVAL User: CH Sesh Kumar
Authorized by A.R.M. RAO on 22-Mar-2011 Timestamp: 25-Mar-2011
Approved by Dr.Tushar Desai on 21-Mar-2011 Copy number: 3
Authored by ANSHUMAN SARAN on 21-Mar-2011
Document Name: Change Managment in automated QMS Software
Document Number: CQA-CP-GEN-006
Version: 0.0.3.0 Eff date: 28-Mar-2011

STANDARD OPERATING PROCEDURE

CATEGORY : GENERAL PROCEDURE

TITLE : CHANGE MANAGEMENT IN AUTOMATED QUALITY MANAGEMENT
SYSTEM SOFTWARE
DEPARTMENT : CORPORATE QUALITY ASSURANCE

4.19 Review of Change by Change Owner:

4.19.1 The proposed change shall be reviewed, evaluated by the change owner and comments shall
be recorded under Change owner Comments field.

4.19.2 If the change request initiated is found satisfactory, Change Owner shall select Approve in
the Change owner Action field.
4.19.3 If the change request initiated needs further information for evaluation, Change Owner shall
select Need More Details in the Change owner Action field
4.19.4 If the change request initiated is not acceptable, Change Owner shall select Recommend
Void in the Change owner Action field and an assignment shall be generated to Change
Control Coordinator.
4.19.5 If the change request initiated is not acceptable, Change Owner shall select Void in the
Change owner Action field
4.19.6 If the change is acceptable, the Change Owner shall create Action Items with respect to the
functional department (wherever applicable), under Action Items fields.
4.19.6.1 Create Action Items.
4.19.6.1.1 Detailed description of the action to be performed shall be selected by
the Change owner in the Action Item Description field.

Page 9 of 31
¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾
CORPORATE QUALITY ASSURANCE, AUROBINDO PHARMA LIMITED, 313 & 314, BACHUPALLY, QUTHUBULLAPUR, RR DISTRICT, HYDERABAD - 500090
SIGNATURES DURING APPROVAL User: CH Sesh Kumar
Authorized by A.R.M. RAO on 22-Mar-2011 Timestamp: 25-Mar-2011
Approved by Dr.Tushar Desai on 21-Mar-2011 Copy number: 3
Authored by ANSHUMAN SARAN on 21-Mar-2011
Document Name: Change Managment in automated QMS Software
Document Number: CQA-CP-GEN-006
Version: 0.0.3.0 Eff date: 28-Mar-2011

STANDARD OPERATING PROCEDURE

CATEGORY : GENERAL PROCEDURE

TITLE : CHANGE MANAGEMENT IN AUTOMATED QUALITY MANAGEMENT
SYSTEM SOFTWARE
DEPARTMENT : CORPORATE QUALITY ASSURANCE

4.19.6.1.2 Appropriate Action item type shall be selected by the Change owner.
4.19.6.1.2.1 Pre-Implementation: This action item shall be selected
if the action item needs to be implemented before
proceeding further. Change owner shall select the
appropriate field for “Complete action item before
proceeding as YES or NO.
Eg: To file a prior approval supplement/ CBE-30/CBE-
0 with the Regulatory agency.
4.19.6.1.2.2 Implementation: Change owner shall select this action
item, if the action item needs to be implemented after
Pre-Implementation action items.
Eg: Revision of Master Batch Processing Records.
4.19.6.1.2.3 Follow-up: Change owner shall select this action item,
if the action item needs to be executed with regular
follow-up
Eg: Submission of stability sample
4.19.6.1.3 Appropriate department under the field Assign Functional group
shall be selected by the Change owner.
4.19.6.1.4 Action Item Owner and Action Item Approver shall be selected by
the Change owner to execute and approve the action item respectively.
4.19.6.1.5 Action Item Execution Type shall be selected from the following
options
4.19.6.1.5.1 Documentation
4.19.6.1.5.2 Training
4.19.6.1.5.3 Others
4.19.6.1.6 If the action item relates to the revision of the document, select
Documentation,
4.19.6.1.6.1 On selection of Documentation, the following fields
shall appear.
4.19.6.1.6.1.1 Document Name
4.19.6.1.6.1.2 Link for Production Documents
4.19.6.1.6.2 Document name shall be recorded by the change
owner.

Page 10 of 31
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CORPORATE QUALITY ASSURANCE, AUROBINDO PHARMA LIMITED, 313 & 314, BACHUPALLY, QUTHUBULLAPUR, RR DISTRICT, HYDERABAD - 500090
SIGNATURES DURING APPROVAL User: CH Sesh Kumar
Authorized by A.R.M. RAO on 22-Mar-2011 Timestamp: 25-Mar-2011
Approved by Dr.Tushar Desai on 21-Mar-2011 Copy number: 3
Authored by ANSHUMAN SARAN on 21-Mar-2011
Document Name: Change Managment in automated QMS Software
Document Number: CQA-CP-GEN-006
Version: 0.0.3.0 Eff date: 28-Mar-2011

STANDARD OPERATING PROCEDURE

CATEGORY : GENERAL PROCEDURE

TITLE : CHANGE MANAGEMENT IN AUTOMATED QUALITY MANAGEMENT
SYSTEM SOFTWARE
DEPARTMENT : CORPORATE QUALITY ASSURANCE

4.19.6.1.6.3
Selected document shall appear in the field Document
Name.
4.19.6.1.6.4 If the action item is related to training, select
Training.
4.19.6.1.6.5 If the action item is other than the above mentioned
execution type, select Other and record the same in the
designated field.
Eg: Execution of validation activity, Submission of
stability sample.
4.19.6.1.6.6 After the change request is approved by the Corporate
Quality Assurance Head (in case of major/moderate
change) / QA In -Charge (in case of minor change), an
assignment to execute the action items shall be
generated.
4.20 Review of Change request by Change control coordinator [QA Reviewer]:
4.20.1 Evaluation for routing to Cross-Functional Groups
4.20.1.1 The proposed change shall be reviewed by the Change control coordinator.
4.20.1.2 Functional group(s) shall be selected under Functional Group whose review is
necessary to evaluate the proposed change.
4.20.1.3 Target Completion Date for functional review shall be assigned by the change
control coordinator.
4.20.1.4 The comments shall be recorded under QA Comments field.

Page 11 of 31
¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾
CORPORATE QUALITY ASSURANCE, AUROBINDO PHARMA LIMITED, 313 & 314, BACHUPALLY, QUTHUBULLAPUR, RR DISTRICT, HYDERABAD - 500090
SIGNATURES DURING APPROVAL User: CH Sesh Kumar
Authorized by A.R.M. RAO on 22-Mar-2011 Timestamp: 25-Mar-2011
Approved by Dr.Tushar Desai on 21-Mar-2011 Copy number: 3
Authored by ANSHUMAN SARAN on 21-Mar-2011
Document Name: Change Managment in automated QMS Software
Document Number: CQA-CP-GEN-006
Version: 0.0.3.0 Eff date: 28-Mar-2011

STANDARD OPERATING PROCEDURE

CATEGORY : GENERAL PROCEDURE

TITLE : CHANGE MANAGEMENT IN AUTOMATED QUALITY MANAGEMENT
SYSTEM SOFTWARE
DEPARTMENT : CORPORATE QUALITY ASSURANCE

4.20.2 Evaluation for routing to Regulatory Affairs review

4.20.2.1 Change control coordinator shall select appropriately under the field “Is RA
Review Required?” from either of these two options.
4.20.2.1.1 No Regulatory Impact. Not Required - if review by Regulatory
Affairs is not required.
4.20.2.1.2 After Functional Review –if review by Regulatory Affairs is
required.
4.20.2.2 RA reviewer shall be selected by the change control coordinator under Route to,
  based on the market to which the proposed change is applicable.
4.20.3 Evaluation for routing to Contract Giver / Qualified Person (CG/QP) review
4.20.3.1 Change control coordinator shall select appropriately under the field “Is CG/QP
Review Required?” from either of these two options.
4.20.3.1.1 No CG/QP Impact. Not Required. –if review by CG/QP is not
required.
4.20.3.1.2 After Functional Review –if CG/QP review for the proposed change
is required, as per the Technical agreement with the Contract Giver.
4.20.3.2 The following additional fields shall pop up, if the Change control coordinator
selects the option “After Functional Review”.
4.20.3.2.1 CG/QP E-mail address.
4.20.3.2.2 CG/QP name.
4.20.4 Accordingly CG/QP e- mail address and name shall be recorded by the change control
coordinator.
4.20.5 Change control coordinator shall select Approve in the QA Action field.
4.20.6 If further information is required for evaluation of the Change, Change control coordinator
shall select Need More Details in the QA Action field
Page 12 of 31
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CORPORATE QUALITY ASSURANCE, AUROBINDO PHARMA LIMITED, 313 & 314, BACHUPALLY, QUTHUBULLAPUR, RR DISTRICT, HYDERABAD - 500090
SIGNATURES DURING APPROVAL User: CH Sesh Kumar
Authorized by A.R.M. RAO on 22-Mar-2011 Timestamp: 25-Mar-2011
Approved by Dr.Tushar Desai on 21-Mar-2011 Copy number: 3
Authored by ANSHUMAN SARAN on 21-Mar-2011
Document Name: Change Managment in automated QMS Software
Document Number: CQA-CP-GEN-006
Version: 0.0.3.0 Eff date: 28-Mar-2011

STANDARD OPERATING PROCEDURE

CATEGORY : GENERAL PROCEDURE

TITLE : CHANGE MANAGEMENT IN AUTOMATED QUALITY MANAGEMENT
SYSTEM SOFTWARE
DEPARTMENT : CORPORATE QUALITY ASSURANCE

4.20.7 If the proposed Change is not acceptable, Change control coordinator shall select Void in the
QA Action field
4.21 Functional Review of Change:
4.21.1 Based on the functional groups selected by the Change control coordinator, Functional
reviewers shall receive an assignment to perform the impact and / or risk analysis for the
proposed change.
4.21.2 Functional reviewer shall record the appropriate details for the following fields under
Functional Impact Analysis section as given.

4.21.3 Action items shall be created by the functional reviewer based on the impact analysis.
4.21.4 If the functional review is completed under the field Functional Reviewer Action, Functional
reviewer shall select “Impact analysis Done”

4.21.5 If Functional reviewer needs additional information to carry out impact analysis, then
Functional reviewer shall select Need More Details under the field Functional Reviewer
Action and shall record the comments in the designated field. And an assignment shall be
generated to Change control coordinator.
4.22 Functional Assessment of Change by Change Control Coordinator:
4.22.1 After completion of functional review by the functional review owners, Change control
coordinator shall receive the assignment
4.22.2 Change control coordinator shall verify the functional review and action items created with
respect to the proposed change and Approve if it is satisfactory.

Page 13 of 31
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CORPORATE QUALITY ASSURANCE, AUROBINDO PHARMA LIMITED, 313 & 314, BACHUPALLY, QUTHUBULLAPUR, RR DISTRICT, HYDERABAD - 500090
SIGNATURES DURING APPROVAL User: CH Sesh Kumar
Authorized by A.R.M. RAO on 22-Mar-2011 Timestamp: 25-Mar-2011
Approved by Dr.Tushar Desai on 21-Mar-2011 Copy number: 3
Authored by ANSHUMAN SARAN on 21-Mar-2011
Document Name: Change Managment in automated QMS Software
Document Number: CQA-CP-GEN-006
Version: 0.0.3.0 Eff date: 28-Mar-2011

STANDARD OPERATING PROCEDURE

CATEGORY : GENERAL PROCEDURE

TITLE : CHANGE MANAGEMENT IN AUTOMATED QUALITY MANAGEMENT
SYSTEM SOFTWARE
DEPARTMENT : CORPORATE QUALITY ASSURANCE

4.22.3 If additional details are required or action items needs to be created, Change control
coordinator shall select Return to Functional Owner under the field QA Reviewer Action.
4.22.4 Change control coordinator shall record the comments in the QA Comments field.

4.22.5 When Change control coordinator receives an assignment stating that Need More Details for
impact analysis from functional reviewer, then additional details shall be provided and
Return To Functional Owner shall be selected under the field QA Reviewer Action.

4.22.6 After completion of functional assessment by the Change control coordinator, assignment
shall be generated to RA personnel for review and approval, wherever required.
4.23 Regulatory Review of Change Request:
4.23.1 Regulatory Reviewer shall review the change request and evaluate the impact of the
proposed change on the regulatory commitment.
4.23.2 Regulatory Reviewer shall review the Product Status in the Change details section and shall
modify accordingly, if applicable.
4.23.3 Regulatory Reviewer shall create action items based on the impact analysis.
4.23.4 In addition to the existing fields, Regulatory Reviewer need to record the appropriate
regulatory action in the Regulatory Action field as shown in the screen shot.

Page 14 of 31
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CORPORATE QUALITY ASSURANCE, AUROBINDO PHARMA LIMITED, 313 & 314, BACHUPALLY, QUTHUBULLAPUR, RR DISTRICT, HYDERABAD - 500090
SIGNATURES DURING APPROVAL User: CH Sesh Kumar
Authorized by A.R.M. RAO on 22-Mar-2011 Timestamp: 25-Mar-2011
Approved by Dr.Tushar Desai on 21-Mar-2011 Copy number: 3
Authored by ANSHUMAN SARAN on 21-Mar-2011
Document Name: Change Managment in automated QMS Software
Document Number: CQA-CP-GEN-006
Version: 0.0.3.0 Eff date: 28-Mar-2011

STANDARD OPERATING PROCEDURE

CATEGORY : GENERAL PROCEDURE

TITLE : CHANGE MANAGEMENT IN AUTOMATED QUALITY MANAGEMENT
SYSTEM SOFTWARE
DEPARTMENT : CORPORATE QUALITY ASSURANCE

4.23.5 The impact of the proposed change on the regulatory filing shall be reviewed by the
Regulatory Reviewer.
4.23.6 If there is impact on regulatory filing, the option Yes shall be selected for the field Impact on
Regulatory Filing. If Yes, additional field shall pop up as shown in the screenshot.
4.23.7 The option No shall be selected, if there is no impact on regulatory filing.

4.23.8 Regulatory Reviewer shall select the appropriate Regulatory Action, Filing Region and
Type of Change Notification / Approval appropriately as stated in the table.
Page 15 of 31
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CORPORATE QUALITY ASSURANCE, AUROBINDO PHARMA LIMITED, 313 & 314, BACHUPALLY, QUTHUBULLAPUR, RR DISTRICT, HYDERABAD - 500090
SIGNATURES DURING APPROVAL User: CH Sesh Kumar
Authorized by A.R.M. RAO on 22-Mar-2011 Timestamp: 25-Mar-2011
Approved by Dr.Tushar Desai on 21-Mar-2011 Copy number: 3
Authored by ANSHUMAN SARAN on 21-Mar-2011
Document Name: Change Managment in automated QMS Software
Document Number: CQA-CP-GEN-006
Version: 0.0.3.0 Eff date: 28-Mar-2011

STANDARD OPERATING PROCEDURE

CATEGORY : GENERAL PROCEDURE

TITLE : CHANGE MANAGEMENT IN AUTOMATED QUALITY MANAGEMENT
SYSTEM SOFTWARE
DEPARTMENT : CORPORATE QUALITY ASSURANCE

S. No. Regulatory Action Regulatory Region Type of change notification / approval

US None
EU None
1. New Application
South Africa Type D
Others None
US Prior Approval Supplement
EU Type II
2. Prior Approval
South Africa Type C
Others None
CBE
US
CBE – 30
3 Prior Notification EU Type IB
South Africa Type B
Others None
US Annual update
South Africa Type A
4 Immediate Notification not required EU Type IA
Others None
5 No Action Not Applicable None

4.23.9 Regulatory Reviewer shall create action items by selecting appropriate action owner and
action approver.
4.23.10 Regulatory Reviewer shall verify the functional review(s) and action items created with
respect to the proposed changes and approve if it is satisfactory.
4.23.11 If Regulatory Reviewer requires additional information to carry out impact analysis then RA
reviewer shall select Need More Details under the field Regulatory Reviewer Action and
Comments shall be recorded in the designated field.
4.23.12 Assignment shall be generated to Change control coordinator for evaluation and to provide
additional details
4.23.13 If the change is not acceptable, Regulatory Reviewer shall select Recommend Void in the
Regulatory Reviewer Action field.
4.24 CG/QP Review of Change Request:
4.24.1 Customer Technical Support personnel shall receive the assignment on behalf of CG/QP.
4.24.2 Customer Technical Support personnel shall send the hard copy/scanned copy of Change
Details report to the respective CG/QP personnel for review and approval through mail.
4.24.3 Customer Technical Support Personnel shall record the details of CG/QP Sent on and shall
select the option “Save & Close” the form.
4.24.4 Customer Technical Support personnel shall not move forward with the Change until
approval/rejection is obtained from the CG/QP Reviewer.

Page 16 of 31
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CORPORATE QUALITY ASSURANCE, AUROBINDO PHARMA LIMITED, 313 & 314, BACHUPALLY, QUTHUBULLAPUR, RR DISTRICT, HYDERABAD - 500090
SIGNATURES DURING APPROVAL User: CH Sesh Kumar
Authorized by A.R.M. RAO on 22-Mar-2011 Timestamp: 25-Mar-2011
Approved by Dr.Tushar Desai on 21-Mar-2011 Copy number: 3
Authored by ANSHUMAN SARAN on 21-Mar-2011
Document Name: Change Managment in automated QMS Software
Document Number: CQA-CP-GEN-006
Version: 0.0.3.0 Eff date: 28-Mar-2011

STANDARD OPERATING PROCEDURE

CATEGORY : GENERAL PROCEDURE

TITLE : CHANGE MANAGEMENT IN AUTOMATED QUALITY MANAGEMENT
SYSTEM SOFTWARE
DEPARTMENT : CORPORATE QUALITY ASSURANCE

4.24.5 If CG/QP needs additional information to carry out impact analysis, Need More Details
option shall be selected under the CG/QP Reviewer Action field. An assignment shall be
generated to Change Control Coordinator.
4.24.6 If the proposed change(s) is not acceptable, CG/QP shall Recommend to void the change
request. In such cases, Change Control Coordinator shall void the change.
4.24.7 If the proposed changes are satisfactory, CG/QP shall Approve the change request under
CG/QP Reviewer Action field.
4.24.8 If the change request is approved by the CG/QP, then following additional fields will pop-up.
4.24.8.1 CG/QP Sent on
4.24.8.2 CG/QP Approved on
4.24.8.3 CG/QP Approved by

4.24.9 Customer Technical Support personnel shall record the details of “Approved by, Approved
on” and comments if any, on behalf of the CG/QP after their approval. The e-mail/ scanned
copy of the approval shall be attached as a proof of the approval.
4.24.10 If system access is available to the CG/QP, Authorized Representative of the Contract Giver
or the Qualified Person (CG/QP Reviewer) of the Marketing Authorization Holder shall
perform the above mentioned activities.
4.25 Final QA Review of proposed Change by Change Control Coordinator [Final QA reviewer]:
4.25.1 The proposed change shall be evaluated by the Change Control Coordinator and the action
items created at different stages of the approval process shall be reviewed. Based on the
evaluation, Change Control Coordinator shall create or delete action items.
4.25.2 Change Control Coordinator has the following options after review:

Page 17 of 31
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CORPORATE QUALITY ASSURANCE, AUROBINDO PHARMA LIMITED, 313 & 314, BACHUPALLY, QUTHUBULLAPUR, RR DISTRICT, HYDERABAD - 500090
SIGNATURES DURING APPROVAL User: CH Sesh Kumar
Authorized by A.R.M. RAO on 22-Mar-2011 Timestamp: 25-Mar-2011
Approved by Dr.Tushar Desai on 21-Mar-2011 Copy number: 3
Authored by ANSHUMAN SARAN on 21-Mar-2011
Document Name: Change Managment in automated QMS Software
Document Number: CQA-CP-GEN-006
Version: 0.0.3.0 Eff date: 28-Mar-2011

STANDARD OPERATING PROCEDURE

CATEGORY : GENERAL PROCEDURE

TITLE : CHANGE MANAGEMENT IN AUTOMATED QUALITY MANAGEMENT
SYSTEM SOFTWARE
DEPARTMENT : CORPORATE QUALITY ASSURANCE

4.25.2.1 Approve all Minor Change Controls.

4.25.2.2 Forward Major and Moderate change controls to CAB Review.
4.25.2.3 Void the change request if found invalid or if it is recommended to void by
approvers.
4.25.2.4 Request Change Owner review for additional details

4.25.2.5
Change Control Coordinator shall request Rework if required. Then assignment
shall be generated to Change Owner for review and approval.
4.25.3 Then the process flow shall continue from Point No.4.19.
4.26 CAB Review of Change:
4.26.1 The major and moderate change requests shall be reviewed by the Corporate Quality
Assurance Head or Authorized Deputy.
4.26.2 Corporate Quality Assurance Head Senior management representative has the following
options:
4.26.2.1 Approve: If found satisfactory
4.26.2.2 Recommend Void: If change is invalid
4.26.2.3 Need more details: If further details are required to evaluate.
4.26.3 After approval by the Corporate Quality Assurance Head, action items shall be generated to
Change Action Item Owners to execute the action items.
4.27 Execution of Action Item:
4.27.1 Action items shall be generated to designated owners in the following order based on the
action item type selected during creation of action items.
4.27.1.1 Pre-Implementation action items
4.27.1.2 Implementation action items
4.27.1.3 Follow-up action items
4.27.2 The proposed change shall be executed by the Action Item Owner.
4.27.3 The details of the implemented action shall be recorded in the Action Item Execution
Details field by the Action item owner.
4.27.4 The implemented action shall be recorded as
4.27.4.1 Pass: If found satisfactory.
Page 18 of 31
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CORPORATE QUALITY ASSURANCE, AUROBINDO PHARMA LIMITED, 313 & 314, BACHUPALLY, QUTHUBULLAPUR, RR DISTRICT, HYDERABAD - 500090
SIGNATURES DURING APPROVAL User: CH Sesh Kumar
Authorized by A.R.M. RAO on 22-Mar-2011 Timestamp: 25-Mar-2011
Approved by Dr.Tushar Desai on 21-Mar-2011 Copy number: 3
Authored by ANSHUMAN SARAN on 21-Mar-2011
Document Name: Change Managment in automated QMS Software
Document Number: CQA-CP-GEN-006
Version: 0.0.3.0 Eff date: 28-Mar-2011

STANDARD OPERATING PROCEDURE

CATEGORY : GENERAL PROCEDURE

TITLE : CHANGE MANAGEMENT IN AUTOMATED QUALITY MANAGEMENT
SYSTEM SOFTWARE
DEPARTMENT : CORPORATE QUALITY ASSURANCE

4.27.4.2 Fail: If implementation of the action fails.

4.27.4.3 Inconclusive: If the implementation status cannot be evaluated.

Pass
Fail
Inconclusive

4.27.5 The date of action item completion shall be recorded in the designated field.
4.27.6 External Reference ID, if any shall be recorded.
4.28 Approval of Action Item:
4.28.1 Implemented Action (change) shall be reviewed.
4.28.2 Department In-Charge (Action Item Approver) has the following options.
4.28.2.1 Approve: If found satisfactory
4.28.2.2 Void: If executed action item is not acceptable.
4.28.2.3 Need more details: If further details are required to evaluate.

Approve
Need more details
Reject

4.29 Review of Action Item by Change control coordinator:

4.29.1 After approval of the Action Item by the Department In-Charge, assignment shall be
generated to Change control coordinator for review and approval.
4.29.2 Change control coordinator has the following options.
4.29.2.1 Approve: If found satisfactory
4.29.2.2 Need more details: If further details are required to evaluate.

Page 19 of 31
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CORPORATE QUALITY ASSURANCE, AUROBINDO PHARMA LIMITED, 313 & 314, BACHUPALLY, QUTHUBULLAPUR, RR DISTRICT, HYDERABAD - 500090
SIGNATURES DURING APPROVAL User: CH Sesh Kumar
Authorized by A.R.M. RAO on 22-Mar-2011 Timestamp: 25-Mar-2011
Approved by Dr.Tushar Desai on 21-Mar-2011 Copy number: 3
Authored by ANSHUMAN SARAN on 21-Mar-2011
Document Name: Change Managment in automated QMS Software
Document Number: CQA-CP-GEN-006
Version: 0.0.3.0 Eff date: 28-Mar-2011

STANDARD OPERATING PROCEDURE

CATEGORY : GENERAL PROCEDURE

TITLE : CHANGE MANAGEMENT IN AUTOMATED QUALITY MANAGEMENT
SYSTEM SOFTWARE
DEPARTMENT : CORPORATE QUALITY ASSURANCE

4.29.3 If the execution details are approved, then a message shall pop-up to reconfirm the same as
shown below. Accept and submit the assignment

4.30 Document first results by Department In-Charge [Change owner]:

4.30.1 After completion of execution and approval of all the action items for the change, an
assignment shall be generated to Department In-Charge to Document the First Results for
the change.
4.30.2 Department In-Charge shall record the actual effective date and details of First Impact
Results for the change and select the Outcome with Justification / Comments.

4.30.3 Outcome of the change may be

4.30.3.1 Results as Intended: If the change implementation is found to be satisfactory.
4.30.3.2 Results Not as Intended: If the change implementation is not found to be
satisfactory
4.30.3.3 Not Applicable: If the change implementation status cannot be evaluated.
4.30.3.4 If outcome of the change is Results Not as Intended, then new change request
shall be initiated to reverse the change.
4.30.4 Change request number for the reversal shall be recorded in New Change Request Number
field.

Page 20 of 31
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CORPORATE QUALITY ASSURANCE, AUROBINDO PHARMA LIMITED, 313 & 314, BACHUPALLY, QUTHUBULLAPUR, RR DISTRICT, HYDERABAD - 500090
SIGNATURES DURING APPROVAL User: CH Sesh Kumar
Authorized by A.R.M. RAO on 22-Mar-2011 Timestamp: 25-Mar-2011
Approved by Dr.Tushar Desai on 21-Mar-2011 Copy number: 3
Authored by ANSHUMAN SARAN on 21-Mar-2011
Document Name: Change Managment in automated QMS Software
Document Number: CQA-CP-GEN-006
Version: 0.0.3.0 Eff date: 28-Mar-2011

STANDARD OPERATING PROCEDURE

CATEGORY : GENERAL PROCEDURE

TITLE : CHANGE MANAGEMENT IN AUTOMATED QUALITY MANAGEMENT
SYSTEM SOFTWARE
DEPARTMENT : CORPORATE QUALITY ASSURANCE

4.30.5 If change executed is Temporary and the change needs to be made Permanent, then a new
change request shall be initiated.
4.30.6 Change request number for the same shall be recorded under New Change Request
Number field.
4.30.7 Department In-Charge shall record Yes or No in the designated field whether change needs to
be made as Permanent or not.
4.30.8 Department In-Charge shall record Last Impact Results, First Impact Results after change
reversal with Justification / Comments.

4.31 Change close out:

4.31.1 If the change is implemented and the results are satisfactory, the change request shall be
closed by the Change control coordinator.
4.31.2 If additional information is required to close the change, then Change control coordinator
shall select Need More Details under the Close Change Action field and shall record the
comments in the designated field.
4.31.3 If Change control coordinator selects Need More Details, assignment shall be generated to
department in charge for review and to document the first results accordingly.
4.32 Change Request Numbering System:
4.32.1 Change Request ID shall be generated by the system automatically after initiation of change
request.
4.32.2 Change Request ID shall be as follows,
APL - XXX - CC - XX - XXXX
Page 21 of 31
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CORPORATE QUALITY ASSURANCE, AUROBINDO PHARMA LIMITED, 313 & 314, BACHUPALLY, QUTHUBULLAPUR, RR DISTRICT, HYDERABAD - 500090
SIGNATURES DURING APPROVAL User: CH Sesh Kumar
Authorized by A.R.M. RAO on 22-Mar-2011 Timestamp: 25-Mar-2011
Approved by Dr.Tushar Desai on 21-Mar-2011 Copy number: 3
Authored by ANSHUMAN SARAN on 21-Mar-2011
Document Name: Change Managment in automated QMS Software
Document Number: CQA-CP-GEN-006
Version: 0.0.3.0 Eff date: 28-Mar-2011

STANDARD OPERATING PROCEDURE

CATEGORY : GENERAL PROCEDURE

TITLE : CHANGE MANAGEMENT IN AUTOMATED QUALITY MANAGEMENT
SYSTEM SOFTWARE
DEPARTMENT : CORPORATE QUALITY ASSURANCE

Name of the Operating Change Last two digits

- - - - Serial Number
Organization Unit Code Control of the Year
4.32.2.1 The First 3 alphabets “APL” denote Aurobindo Pharma Limited.
4.32.2.2 4th Character is “-”.
4.32.2.3 The next alphabets shall denote Operating Unit Code (Formulation Unit 3 shall be
denoted as FU3, Corporate Quality Assurance shall be denoted as CQA).
4.32.2.4 The next Character is “-”.
4.32.2.5 The next two characters denote Module Name i.e. Change Control.
4.32.2.6 The next Character is “-”.
4.32.2.7 The next two characters are numeric and shall represent the last two digit of the
current calendar year (11 denotes the year 2011).
4.32.2.8 The next Character is “-”.
4.32.2.9 The last four characters are numeric and shall represent the serial number of
Change request under each unit.
F Note: The Serial Number shall be reset automatically at the beginning of
each calendar year.
4.33 Reports:
4.33.1 Change Control Log (Format – 3) shall be generated by the system and QA shall maintain the
hard copy of the log reports by taking the print out, whenever required.
4.33.2 Change Details Report (Format – 4) of every Change shall be printed and archived.

5 ENVIRONMENT, HEALTH AND SAFETY

¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾
Not Applicable

6 ABBREVATIONS / GLOSSARY
¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾
6.1 QMS - Quality Management System
6.2 DMS - Document Management System
6.3 APL - Aurobindo Pharma Limited
6.4 CC - Change Control
6.5 HOD - Head of Department
6.6 RA - Regulatory Affairs
6.7 QA - Quality Assurance
6.8 CG - Contract Giver
6.9 QP - Qualified Person
6.10 CAB - Change Approval Board
Page 22 of 31
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CORPORATE QUALITY ASSURANCE, AUROBINDO PHARMA LIMITED, 313 & 314, BACHUPALLY, QUTHUBULLAPUR, RR DISTRICT, HYDERABAD - 500090
SIGNATURES DURING APPROVAL User: CH Sesh Kumar
Authorized by A.R.M. RAO on 22-Mar-2011 Timestamp: 25-Mar-2011
Approved by Dr.Tushar Desai on 21-Mar-2011 Copy number: 3
Authored by ANSHUMAN SARAN on 21-Mar-2011
Document Name: Change Managment in automated QMS Software
Document Number: CQA-CP-GEN-006
Version: 0.0.3.0 Eff date: 28-Mar-2011

STANDARD OPERATING PROCEDURE

CATEGORY : GENERAL PROCEDURE

TITLE : CHANGE MANAGEMENT IN AUTOMATED QUALITY MANAGEMENT
SYSTEM SOFTWARE
DEPARTMENT : CORPORATE QUALITY ASSURANCE

6.11 ID - Identification
6.12 SOP - Standard Operating Procedure
6.13 LOV - List of Values
6.14 API - Active Pharmaceutical Ingredient

7 REFERENCES
¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾
7.1 Guidance to the Industry - “Changes to the approved NDA/ANDA”-USFDA-CDER
7.2 Guidance for the Industry – “Immediate release Solid Oral dosage forms” -SUPAC
7.3 Guideline on dossier requirements for Type 1A and 1B notifications.

8 FLOWCHART
¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾
Page 23 of 31
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CORPORATE QUALITY ASSURANCE, AUROBINDO PHARMA LIMITED, 313 & 314, BACHUPALLY, QUTHUBULLAPUR, RR DISTRICT, HYDERABAD - 500090
SIGNATURES DURING APPROVAL User: CH Sesh Kumar
Authorized by A.R.M. RAO on 22-Mar-2011 Timestamp: 25-Mar-2011
Approved by Dr.Tushar Desai on 21-Mar-2011 Copy number: 3
Authored by ANSHUMAN SARAN on 21-Mar-2011
Document Name: Change Managment in automated QMS Software
Document Number: CQA-CP-GEN-006
Version: 0.0.3.0 Eff date: 28-Mar-2011

STANDARD OPERATING PROCEDURE

CATEGORY : GENERAL PROCEDURE

TITLE : CHANGE MANAGEMENT IN AUTOMATED QUALITY MANAGEMENT
SYSTEM SOFTWARE
DEPARTMENT : CORPORATE QUALITY ASSURANCE

The flow chart for Change Management

Page 24 of 31
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CORPORATE QUALITY ASSURANCE, AUROBINDO PHARMA LIMITED, 313 & 314, BACHUPALLY, QUTHUBULLAPUR, RR DISTRICT, HYDERABAD - 500090
SIGNATURES DURING APPROVAL User: CH Sesh Kumar
Authorized by A.R.M. RAO on 22-Mar-2011 Timestamp: 25-Mar-2011
Approved by Dr.Tushar Desai on 21-Mar-2011 Copy number: 3
Authored by ANSHUMAN SARAN on 21-Mar-2011
Document Name: Change Managment in automated QMS Software
Document Number: CQA-CP-GEN-006
Version: 0.0.3.0 Eff date: 28-Mar-2011

STANDARD OPERATING PROCEDURE

CATEGORY : GENERAL PROCEDURE

TITLE : CHANGE MANAGEMENT IN AUTOMATED QUALITY MANAGEMENT
SYSTEM SOFTWARE
DEPARTMENT : CORPORATE QUALITY ASSURANCE

9 FORMATS
Page 25 of 31
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CORPORATE QUALITY ASSURANCE, AUROBINDO PHARMA LIMITED, 313 & 314, BACHUPALLY, QUTHUBULLAPUR, RR DISTRICT, HYDERABAD - 500090
SIGNATURES DURING APPROVAL User: CH Sesh Kumar
Authorized by A.R.M. RAO on 22-Mar-2011 Timestamp: 25-Mar-2011
Approved by Dr.Tushar Desai on 21-Mar-2011 Copy number: 3
Authored by ANSHUMAN SARAN on 21-Mar-2011
Document Name: Change Managment in automated QMS Software
Document Number: CQA-CP-GEN-006
Version: 0.0.3.0 Eff date: 28-Mar-2011

STANDARD OPERATING PROCEDURE

CATEGORY : GENERAL PROCEDURE

TITLE : CHANGE MANAGEMENT IN AUTOMATED QUALITY MANAGEMENT
SYSTEM SOFTWARE
DEPARTMENT : CORPORATE QUALITY ASSURANCE

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9.1 Format 1: Change Initiation form

9.2 Format 2: Change Control Log

Page 26 of 31
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CORPORATE QUALITY ASSURANCE, AUROBINDO PHARMA LIMITED, 313 & 314, BACHUPALLY, QUTHUBULLAPUR, RR DISTRICT, HYDERABAD - 500090
SIGNATURES DURING APPROVAL User: CH Sesh Kumar
Authorized by A.R.M. RAO on 22-Mar-2011 Timestamp: 25-Mar-2011
Approved by Dr.Tushar Desai on 21-Mar-2011 Copy number: 3
Authored by ANSHUMAN SARAN on 21-Mar-2011
Document Name: Change Managment in automated QMS Software
Document Number: CQA-CP-GEN-006
Version: 0.0.3.0 Eff date: 28-Mar-2011

STANDARD OPERATING PROCEDURE

CATEGORY : GENERAL PROCEDURE

TITLE : CHANGE MANAGEMENT IN AUTOMATED QUALITY MANAGEMENT
SYSTEM SOFTWARE
DEPARTMENT : CORPORATE QUALITY ASSURANCE

9.3 Format 3: Change Details Report

Page 27 of 31
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CORPORATE QUALITY ASSURANCE, AUROBINDO PHARMA LIMITED, 313 & 314, BACHUPALLY, QUTHUBULLAPUR, RR DISTRICT, HYDERABAD - 500090
SIGNATURES DURING APPROVAL User: CH Sesh Kumar
Authorized by A.R.M. RAO on 22-Mar-2011 Timestamp: 25-Mar-2011
Approved by Dr.Tushar Desai on 21-Mar-2011 Copy number: 3
Authored by ANSHUMAN SARAN on 21-Mar-2011
Document Name: Change Managment in automated QMS Software
Document Number: CQA-CP-GEN-006
Version: 0.0.3.0 Eff date: 28-Mar-2011

STANDARD OPERATING PROCEDURE

CATEGORY : GENERAL PROCEDURE

TITLE : CHANGE MANAGEMENT IN AUTOMATED QUALITY MANAGEMENT
SYSTEM SOFTWARE
DEPARTMENT : CORPORATE QUALITY ASSURANCE

Change Header Details

Change ID Initiated By Initiated On

Organization Level Organization Name Change Status

Change Source Customer/Market/License Change Source Reference ID

Assigned To

Change Details
Change description Change Owner

Change Type Product Status Change Classification/Priority

Target Effective Date Iteration Number Change Duration(in days)

Actual Effective Date QA Reviewer

Impact
Products Impacted Other Impact

Related Changes
Change Request ID(s)

Change Line Item(s):

Existing

Proposed

Justification

Item Category Item Sub Category

Item Additional Details

Item Justification

Functional Group(s):
Functional Group Target Completion Date

Functional Group Comments

Functional Group Action Function Group Comments

QA Action QA Comments

Impact Assessment Impact Assessment Details

Effort And Cost Estimate Details

Recommendations

Page 28 of 31
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CORPORATE QUALITY ASSURANCE, AUROBINDO PHARMA LIMITED, 313 & 314, BACHUPALLY, QUTHUBULLAPUR, RR DISTRICT, HYDERABAD - 500090
SIGNATURES DURING APPROVAL User: CH Sesh Kumar
Authorized by A.R.M. RAO on 22-Mar-2011 Timestamp: 25-Mar-2011
Approved by Dr.Tushar Desai on 21-Mar-2011 Copy number: 3
Authored by ANSHUMAN SARAN on 21-Mar-2011
Document Name: Change Managment in automated QMS Software
Document Number: CQA-CP-GEN-006
Version: 0.0.3.0 Eff date: 28-Mar-2011

STANDARD OPERATING PROCEDURE

CATEGORY : GENERAL PROCEDURE

TITLE : CHANGE MANAGEMENT IN AUTOMATED QUALITY MANAGEMENT
SYSTEM SOFTWARE
DEPARTMENT : CORPORATE QUALITY ASSURANCE

Sent On Approved On

Approved By

Action Item(s) – NON- RA

Action# Action Item Description

Action Item Type Action Item Due Date Action Item Status

Action Item Execution Type Other Action Item Execution Type

Documentation Request Type Document Name

Assign To Functional Group Action Item Owner Action Item Approver

Action Item Created By Complete Action Item Before Proceeding?

Action Item Execution Results Action Item Completed On External Reference ID

Action Item Execution Details

Approver Action Action Item Approved On

Action Approver Comments

Reviewer Action Reviewer Comments

Action Item(s) – RA & CG/QP

Action# Action Item Description

Action Item Type Action Item Due Date Action Item Status

Regulatory Action Other Regulatory Action

Documentation Request Type Document Name

Assign To Functional Group Action Item Owner Action Item Approver

Action Item Created By Complete Action Item Before Proceeding?

Regulatory Filing

Filing Region Filing Region Description

Filing Country Filing Type

Action Item Execution Results Action Item Completed On External Reference ID

Action Item Execution Details

Approver Action Action Item Approved On

Action Approver Comments

Reviewer Action Reviewer Comments

Review
Initiator Comments

Change Owner Action Change Owner Comments

QA Action QA Comments

Page 29 of 31
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CORPORATE QUALITY ASSURANCE, AUROBINDO PHARMA LIMITED, 313 & 314, BACHUPALLY, QUTHUBULLAPUR, RR DISTRICT, HYDERABAD - 500090
SIGNATURES DURING APPROVAL User: CH Sesh Kumar
Authorized by A.R.M. RAO on 22-Mar-2011 Timestamp: 25-Mar-2011
Approved by Dr.Tushar Desai on 21-Mar-2011 Copy number: 3
Authored by ANSHUMAN SARAN on 21-Mar-2011
Document Name: Change Managment in automated QMS Software
Document Number: CQA-CP-GEN-006
Version: 0.0.3.0 Eff date: 28-Mar-2011

STANDARD OPERATING PROCEDURE

CATEGORY : GENERAL PROCEDURE

TITLE : CHANGE MANAGEMENT IN AUTOMATED QUALITY MANAGEMENT
SYSTEM SOFTWARE
DEPARTMENT : CORPORATE QUALITY ASSURANCE

Is RA Review Required?

Regulatory Reviewer Action Regulatory Reviewer Comments

Is CG/QP Review Required? CG/QP Email Address CG/QP Name

CG Reviewer Action CG Reviewer Comments

CG/QP Sent On CG/QP Approved On CG/QP Approved By

Email Attachments

Final QA Action Final QA Comments

CAB Action CAB Comments

Change Owner Final Action Change Owner Final Comments

Void
Void Change Comments

Change Owner Review

First Impact Results

Outcome Make Change Permanent

New Change Request Number

Last Impact Results

First Impact Results After Change Reversal

Justification / Comments

Reversal Effective Date

Change Results
Close Change? Final Comments

Attachments

Signatures
Process Step Completed By Completed On Signature

10 CHANGE HISTORY
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Not Applicable
Page 30 of 31
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CORPORATE QUALITY ASSURANCE, AUROBINDO PHARMA LIMITED, 313 & 314, BACHUPALLY, QUTHUBULLAPUR, RR DISTRICT, HYDERABAD - 500090
SIGNATURES DURING APPROVAL User: CH Sesh Kumar
Authorized by A.R.M. RAO on 22-Mar-2011 Timestamp: 25-Mar-2011
Approved by Dr.Tushar Desai on 21-Mar-2011 Copy number: 3
Authored by ANSHUMAN SARAN on 21-Mar-2011
Document Name: Change Managment in automated QMS Software
Document Number: CQA-CP-GEN-006
Version: 0.0.3.0 Eff date: 28-Mar-2011

STANDARD OPERATING PROCEDURE

CATEGORY : GENERAL PROCEDURE

TITLE : CHANGE MANAGEMENT IN AUTOMATED QUALITY MANAGEMENT
SYSTEM SOFTWARE
DEPARTMENT : CORPORATE QUALITY ASSURANCE

END OF THE DOCUMENT

Page 31 of 31
¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾¾
CORPORATE QUALITY ASSURANCE, AUROBINDO PHARMA LIMITED, 313 & 314, BACHUPALLY, QUTHUBULLAPUR, RR DISTRICT, HYDERABAD - 500090
SIGNATURES DURING APPROVAL User: CH Sesh Kumar
Authorized by A.R.M. RAO on 22-Mar-2011 Timestamp: 25-Mar-2011
Approved by Dr.Tushar Desai on 21-Mar-2011 Copy number: 3
Authored by ANSHUMAN SARAN on 21-Mar-2011