QAD 002 Change Control Procedure

STELLENCE PHARMSCIENCE PRIVATE LIMITED STANDARD OPERATING
No. 456, Road No.3, Industrial Area, Jigani, PROCEDURE

Bangalore South-560 105, Karnataka, India
Page No. : 1 of 9
DEPARTMENT : QUALITY ASSURANCE Copy No.:
TITLE : CHANGE CONTROL PROCEDURE
SOP No. Supersedes Issue Date Effective Date Review Date
QAD/002/05 QAD/002/04 26/08/2013 JUL 2015
REVISION No. CHANGES INCORPORATED EFFECTIVE DATE
00 New SOP introduced. 15/09/2006
‘Scope’ updated to include revision of SOPs through
change control procedure.
01 Change control proposal form updated to include 27/08/2008
‘Product’ and ‘Batch No.’, review of follow ups to be done,
review of follow ups post approval changes.
Information to the customer wherever applicable,
included in clause 6.7.
The terms minor, major, temporary and permanent
02 08/05/2009
changes briefed under clause 6.9 to 6.9.4.
Change control proposal form, QAD/F/005/01 revised to
include customer information details in annexure-3.
Periodic review. Company name and footer is changed
as per current practice.
03 No change in the change control system.
Steps of procedures arranged in order as per the system 07/05/2011
and documentations being carried out.
Objective and scope of the change control procedure
elaborated for more clarity.
Need for stability studies and the impact of any change
on the retest period included in the SOP text as a part of
04 compliance to audit observations. 22/09/2011
 Periodic review. No major changes in the procedure

 Company name and footer is changed as per current
05 practice. 26/08/2013
 Section 6.6.2.2. made clear.
 Impact analysis elaborated in change control format.
PREPARED BY : VERIFIED AND APPROVED BY : APPROVED BY :

Sign & Date : Sign & Date : Sign & Date :
Name : Arun Kumar CM Name : Sherly Joseph Name : Srinath H

Designation : Officer/Executive-QA Designation : Asst. Manager-QA Designation : AGM/ Head-QA
Page No. : 2 of 9
QAD/002/05 QAD/002/04 26/08/2013 JUL 2015
1.0 OBJECTIVE: To provide a procedure to be followed for any planned change to an established
system, procedure or process and ensure that all planned changes related to any
aspect of manufacturing(production, packing, labelling and storage), testing and
distribution are appropriately proposed, reviewed, assessed and approved by
concerned personnel and QA.
2.0 SCOPE: This procedure applies to all new and existing manufacturing/packing processes,
systems, procedures, protocols, utilities, equipments, computer systems, drug
substances (APIs), intermediates, raw materials, starting materials, suppliers,
components, testing requirements, specification, distribution and any part of the
quality system at the establishment.
For better clarity, points mentioned above under scope are explained below(but not limited)
 Change in the synthetic process, source of raw materials, alternate raw materials, purification
process, primary/secondary containers and closure system, labelling and/or their specification,
process control parameters, sequence of addition, addition or deletion of a step of operation etc.
 Change in sampling plans, expiration/retest dates, product standards, storage conditions, testing
methods, instrument calibration etc.
 Change in equipments, their location, modification, calibration, critical parts of equipments and
process control parameters in utilities which could have impact of process or product quality etc.
 Change in User Requirement Specification (URS) of equipments, facilities and utilities during
project execution and subsequently thereof.


Page No. : 3 of 9
QAD/002/05 QAD/002/04 26/08/2013 JUL 2015
 Changes relevant to computer and / or automated systems which include (but not limited)
modifications to hardware, software, or addition of new programmes etc.
 Changes in approach to validation (process, cleaning, analytical method, computer systems etc),
qualification of equipments, facilities, utilities which come directly in contact with the product,
Change or revision in the protocols.
 Changes in documented procedures (like SOPs, manuals, formats etc) and established systems.
 Change in the supplier of starting / key material(s).
Note: This change control procedure can also be applicable for other management systems like
environment and safety.
3.0 RESPONSIBILITY: Respective Department Heads or person(s) designated by them shall be
responsible for total change control functions including implementation and monitoring of the
change.
4.0 ACCOUNTABILITY: Head-QA
5.0 ABBREVIATIONS :
SOP Standard Operating Procedure Dept. Department
HOD Head of the Department CCP Change control proposal
QAD Quality Assurance Department API Active Pharmaceutical Ingredient
QC Quality Control BMR Batch Manufacturing Record
6.0 PROCEDURE :
6.1 Any change in the areas covered by the scope shall be initiated through a change control proposal
form (Annexure-3) by the originating department.
6.2 The change control originating department shall initially discuss the proposed change with
Head – QA and requests for change control form.


Page No. : 4 of 9
QAD/002/05 QAD/002/04 26/08/2013 JUL 2015
6.3 Executive / Officer- QA shall allot a change control proposal number (CCP number) for the proposed
change. This change control proposal number contains 9 characters and it shall be in the pattern
CCP/XXYYY, where, ‘CCP’ stands for change control proposal, ‘XX’ stands for last two digits of the
year and ‘YYY’ stands for the three digit continuous number.
Example: CCP/13001 means: This is the first change control number allotted for the year 2013 and
so on.
6.4 Executive /Officer-QA shall enter the following details in the change control proposal register
(Annexure-2) before issuing the CCP form.
i. Change Control proposal No. and date
ii. Originating department
iii. Proposed change (briefly mentioned)
iv. Issued by – QA/officer/ Executive shall sign
v. Received by – Officer/ Executive of change initiation department shall sign.
6.4.1 The next column, ‘Status of the CCP’ shall be entered by QA as ‘Closed’ when once the change
control activities are fully completed and follow up actions are verified for completion and signed by
QA with date of closure. This column shall be left blank in the register till all the change control
activities are completed and documented. In case, the change control proposal is cancelled by the
change initiator due to any reasons, QA shall write ‘Cancelled’ in this column and sign with date in
the register. QA shall collect the CCP form from the initiating department, write as ’Cancelled’ with
reason for cancellation in the form, sign with date and file it along with other CCP forms to have
the continuity.
6.4.2 Executive / Officer-QA shall make initial entries like CCP number, date of issue, name of the

Page No. : 5 of 9
QAD/002/05 QAD/002/04 26/08/2013 JUL 2015
initiator, department, product and batch number (as applicable) in the change control format
(as per Annexure-3), take signature of the change initiator and issues the CCP form.
6.5 The proposed change control shall be reviewed by the originating department Head. Current
practice, proposed change, reason for change shall be recorded in the CCP form by the
department Head or his designee along with justification for change with relevant supporting
documents for the proposed change. Head of the originating department or his designee shall
analyse the impact of the change, records the same in the form, list the documents which will be
affected by the change, sign with date and forwards to Head-QA for evaluation and approval.
6.6 Head-QA shall evaluate the change control proposal, categorises the change as ‘minor’ or ‘major’,
‘temporary ‘or ‘permanent’ depending on the nature of the change and forwards it to the concerned
cross functional department(s) for comments and their signature, if applicable.
6.6.1 A ‘minor’ change could be the one which is likely to have no significant impact on the quality of
the product or quality system and a ‘major’ change could be the one which is likely to have impact
on the product quality or quality system or any other aspects depending on the nature of the
change. Major changes shall be evaluated carefully by QA and technical personnel to ensure that
the change should not have adverse effect. This shall be done by recommending for re-validation
or re-qualification depending on the circumstances.
6.6.2 If a major change is related to: Change in the solvent, Change in the control and monitoring of
critical process parameters (eg. Temperature, pressure, pH etc), Use of alternate materials,
Change in the route of synthesis, Change in the sequence of addition of materials, Change in the
packing procedures (like additional precaution to store under inert atmosphere) and/or change in


Page No. : 6 of 9
QAD/002/05 QAD/002/04 26/08/2013 JUL 2015
the primary packing material, Change in the starting material or change in the sourcing of starting
material, Change in the type of drying operation (eg: Fluid bed drying against tray drying) – that
are likely to impact the established retest/expiry period, such process change batch samples shall
be kept for stability study testing as per ICH guidelines as a part of investigation.
6.6.2.1 Decision taken on the need to carry out stability studies to study the impact on established
retest/expiry period shall be recorded by Head-QA in the ‘Follow ups to be done’ column of the
change control form with the responsibility assigned to QC for testing and QA for follow up.
QC shall carry out the stability test (Accelerated/Long term) with an approved protocol to study
the impact of the change on the retest/expiry period as recommended by Head-QA.
6.6.2.2 The results of stability studies and the impact of the change on the quality parameters of the
product during stability testing shall be assessed by Head-QC and QA and documented in the
stability report of the batch in question. The proposed change will not be made permanent unless
it is confirmed that the stability test parameters are not adversely affected. The impact on retest /
expiry date may also be evaluated in case of long-term stability testing.
6.6.3 The changes which are effective only for a certain period of time or for certain number of batches
shall be considered as ‘temporary changes’. Usage of a similar equipment in place of a
equipment which is specified in the batch manufacturing record, change in the batch size of
certain number of batches than the standard batch size as specified in the Batch manufacturing
record etc.
In case of temporary changes wherever any modifications required in the records like changes in
standard input quantities, change in the equipment than the one as mentioned in the batch
manufacturing record shall be corrected by hand and signed by the user department and verified

Page No. : 7 of 9
QAD/002/05 QAD/002/04 26/08/2013 JUL 2015
by QA during review of batch manufacturing record.
6.6.4 The changes which are to be implemented permanently shall be classified under ‘permanent
changes’. These category of changes can be related to the changes in the standard operating
procedures, changes in the formats, change in the batch size, change in the specification etc.
6.7 After receiving the comments from the cross functional department, Head-QA shall evaluate the
change with respect to regulatory, customer requirements and any stability studies requirements
(as mentioned under step number 6.6.2). If any action has to be initiated on any of these aspects,
it shall be recorded by Head-QA in the respective columns of the CCP form and a follow up action
required to be done also be mentioned under follow up column.
6.7.1 Information to regulatory: Regulatory affairs of the organisation generally would also be asked to
judge, if the change internally approved might need external approval and / or customer notification.
In the absence of regulatory staff, this can be judged by Head-QA.
In case of a requirement that a change need to be approved by the regulatory authorities, Head-QA
or Regulatory staff shall forward the necessary details to the authorities and wait till the approval is
obtained and then proceed with the proposed change. In such case, a copy of the approval letter
shall be enclosed with the CCP form.
6.7.2 Customer notification: If the change is in the final step of the API manufacture and involves a
change of equipment, solvent, isolation or purification conditions, key customers shall be contacted
by QA before introducing the change and their approval / opinion shall be sought. Trial
batch/demonstration batch material can be provided to the customer(s) for their experimental use, if
requested by them and wait for their approval before implementing such changes. Also, if there is
any change in the specification and testing method(s) of API(regulatory requirement or in-house

Page No. : 8 of 9
QAD/002/05 QAD/002/04 26/08/2013 JUL 2015
control), same shall be communicated to the customer prior to implementing on permanent basis.
6.7.3 Contract manufacture: For products manufactured under contract, prior approval from the contract
giver shall be sought before implementing the change. If the proposed change is not approved by
the contract giver, the change shall not be implemented.
6.8 When the change evaluation is completed, follow up activities to be done as per the proposed
change shall be recorded with responsibilities by Head-QA in the CCP form and the change shall
be approved and signed by Head-QA with date.
During the evaluation of the change if it is decided that the change cannot be approved, it shall be
‘rejected’ and recorded by Head-QA in the CCP form.
Approval or Rejection of the proposed change shall be communicated to the originating department
by sending a copy of the CCP form.
6.9 If the change proposed is related to company policy or related to Management, Head-QA shall
ensure that the same is approved by the Managing Director or his designee. This shall be
appropriately documented in the CCP form under ‘comments from cross functional departments’.
6.10. Validation activities wherever required shall be carried out in accordance with the change and
relevant approved protocols. Prior to the approval of CCP, Head-QA shall review for any changes
required in the related documents, follow ups to be done as per the change and the same shall be
documented in the CCP with assigned responsibilities.
6.11. The originating department shall update the relevant affected documents, enclose a copy of such
documents and also ensure that necessary training is given to the concerned personnel as
mentioned in the CCP (copy of training record is required). All these supporting documents shall be
part of change control when it is fully implemented.

Page No. : 9 of 9
QAD/002/05 QAD/002/04 26/08/2013 JUL 2015
6.12. After implementation, the post implementation review and verification of corrective actions taken
shall be done by Executive-QA and the Head-QA and sign off the CCP with date. The status of
completion of action shall be mentioned in the Change Control Proposal Form issue register by
Executive-QA. This is the stage where the change control is deemed as ‘closed’
6.13. The original change control proposal form along with all necessary copies of supporting documents
shall be retained by QA. A copy of executed change control form can be provided to the
originating and/or other relevant departments, if required, which will be decided by Head-QA.
6.14. Even after internal approval of the change control, if necessary, the changes implemented may be
informed to the customer, regulatory authorities as decided by Head-QA after discussion with the
management.
6.15 Time Limit: Under normal circumstances, changes related to process, testing, documentation,
procurement etc which are within the activities of the company shall be closed within 15
days. If the change requires resources like infrastructure, equipment modification/procurement
related aspects, the same may be closed within 30 days.
7.0 ANNEXURES:
7.1 Flow chart : Annexure-1
7.2 Change Control Proposal Register (QAD/F/004/02) : Annexure-2
7.3 Change control proposal form (QAD/F/005/04) : Annexure-3


Page No. : 1 of 1
QAD/002/05 QAD/002/04
ANNEXURE – 1
FLOW CHART
Initiate request for change control
proposal form for Proposed changes
Allot serial number in QA
Review the change control proposal by

department head and then by cross-functional
Evaluate the change in detail
Refer to regulatory / contract

giver / customer/CEO / Does the change require Contract giver /
Concerned department for regulatory Approval / customer
approval approval/cross-functional department? Communicate decision with copy to
all concerned departments
Post-introduction and corrective

Does the change require validation or re- actions review
Prepare applicable validation validation studies?
protocols
File original change control proposal
form in QA and update register with
signature
Identify and record the need Does the change require training / re-
training?
Forward to Head-QA for approval /

rejection


Page No. : 1 of 1
QAD/002/05 QAD/002/04
Annexure – 2
STELLENCEPHARMSCIENCE PRIVATE LIMITED
CHANGE CONTROL PROPOSAL REGISTER

Change Date Originating Change proposed Issued by Received Status of the CCP Remarks
Control Department by / Signature
Proposal
No.
QAD/F/004/02 SOP Ref No.: QAD/002


Page No. : 1 of 3
QAD/002/05 QAD/002/04
Annexure – 3
CHANGE CONTROL PROPOSAL FORM
No.456, Road No.3, Industrial Area, Jigani,
Change control proposal number : CCP/ Date :
Name of the Initiator : Signature of the initiator and date :
Department : Product : Batch No. :

Change control proposal for : Process / Process controls / material / specifications and test procedures/
purification system / others .
Others (please specify ) :
Current Practice :
Proposed change :
Reasons for change :
Justifications for the change :
( attach supporting data for change )
Attachments :
Type of change :(Tick whichever is applicable)

Minor Temporary
Major Permanent
QAD/F/005/04 Sop Ref.No. :QAD/002


Page No. : 2 of 3
QAD/002/05 QAD/002/04

No. 456, Road No.3, Industrial Area, Jigani, CHANGE CONTROL PROPOSAL FORM
Impact analysis:
Whether the change has any impact : Yes No NA
If yes ,change impact on : Quality System Procedure Others
(Tick whichever is applicable)
Remarks:
Whether the change requires (Tick whichever is applicable)
(a) Retraining of concerned personnel : Yes No NA
(b) Calibration / Validation studies : Yes No NA
(c) Amendment to SOP / BMR/Manual/ Specification : Yes No NA
(d) Others: Yes No NA
If others, specify :
Checked by ( Department Head) : Date :
Comments from cross functional departments (If applicable ): Required Not Required
Department Comments Signature and date
GM-Operations
Production
Quality Control
Research & Development
Stores/Ware-house
Environment & Safety
Review by AGM/Head-QA
(a) Information to the regulatory :


Page No. : 3 of 3
QAD/002/05 QAD/002/04
(b) Information to the customer :
Stability studies Required / Not required Comments :
QAD/F/005 /04 Sop Ref.No. : QAD/002

No.456, Road No.3, Industrial Area, Jigani, CHANGE CONTROL PROPOSAL FORM
(c)Any other comments :

Follow ups to be done Responsibilities
Approved / Rejected
AGM/Head-QA:
Sign Date :
Details of follow ups done, review and post approval of the change(s) :
Executive-QA : AGM/Head-QA :
Date : Date :
CC : Originating department and other departments ( if required )
QAD/F/005/04 Sop Ref.No. : QAD/002



QAD 002 Change Control Procedure

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

QAD 002 Change Control Procedure

Uploaded by

Copyright:

Available Formats

STELLENCE PHARMSCIENCE PRIVATE LIMITED STANDARD OPERATING

No. 456, Road No.3, Industrial Area, Jigani, PROCEDURE

 Periodic review. No major changes in the procedure

PREPARED BY : VERIFIED AND APPROVED BY : APPROVED BY :

Name : Arun Kumar CM Name : Sherly Joseph Name : Srinath H

PREPARED BY : VERIFIED AND APPROVED BY : APPROVED BY :

Name : Arun Kumar CM Name : Sherly Joseph Name : Srinath H

PREPARED BY : VERIFIED AND APPROVED BY : APPROVED BY :

Name : Arun Kumar CM Name : Sherly Joseph Name : Srinath H

Name : Arun Kumar CM Name : Sherly Joseph Name : Srinath H

PREPARED BY : VERIFIED AND APPROVED BY : APPROVED BY :

Name : Arun Kumar CM Name : Sherly Joseph Name : Srinath H

Name : Arun Kumar CM Name : Sherly Joseph Name : Srinath H

Name : Arun Kumar CM Name : Sherly Joseph Name : Srinath H

Name : Arun Kumar CM Name : Sherly Joseph Name : Srinath H

PREPARED BY : VERIFIED AND APPROVED BY : APPROVED BY :

Name : Arun Kumar CM Name : Sherly Joseph Name : Srinath H

Allot serial number in QA

Review the change control proposal by

Evaluate the change in detail

Refer to regulatory / contract

Post-introduction and corrective

Forward to Head-QA for approval /

PREPARED BY : VERIFIED AND APPROVED BY : APPROVED BY :

Name : Arun Kumar CM Name : Sherly Joseph Name : Srinath H

CHANGE CONTROL PROPOSAL REGISTER

QAD/F/004/02 SOP Ref No.: QAD/002

PREPARED BY : VERIFIED AND APPROVED BY : APPROVED BY :

Name : Arun Kumar CM Name : Sherly Joseph Name : Srinath H

Department : Product : Batch No. :

Others (please specify ) :

Type of change :(Tick whichever is applicable)

PREPARED BY : VERIFIED AND APPROVED BY : APPROVED BY :

Name : Arun Kumar CM Name : Sherly Joseph Name : Srinath H

STELLENCEPHARMSCIENCE PRIVATE LIMITED

PREPARED BY : VERIFIED AND APPROVED BY : APPROVED BY :

Name : Arun Kumar CM Name : Sherly Joseph Name : Srinath H

STELLENCEPHARMSCIENCE PRIVATE LIMITED

(c)Any other comments :

QAD/F/005/04 Sop Ref.No. : QAD/002

PREPARED BY : VERIFIED AND APPROVED BY : APPROVED BY :

Name : Arun Kumar CM Name : Sherly Joseph Name : Srinath H

You might also like