Change Control Procedure SOP

 

1.0              OBJECTIVE:

To lay down the procedure for Changes Control Procedure in quality systems and implementing the change only after evaluation, approval and documentation at -------------------------

2.0              SCOPE:

2.1              This procedure is applicable to changes / deletion made to existing or introduction of new document / manufacturing process / formula / method / facility / equipment / instrument / utilities / layout / software (used in GMP aspects).

2.2              The change proposals are subjected to existing or introduction of new process, product, statutory / regulatory / customer requirements.

2.3              The routine activities like breakdown maintenance, replacement of parts of an equipment / instrument with like to like changes (same make same model), under preventive maintenance and routine calibration shall not come under the scope of this SOP.

3.0              RESPONSIBILITY:

3.1              Originating Department:

3.1.1        Initiation of Change Control, filling details with reason / justification.

3.1.2        Risk assessment of the proposed change.

3.1.3        Coordination with QMS and other department for change control processing.

3.1.4        Implementation of the approved change and

3.1.5        Submission of document to QA

3.2              QMS department:                  

3.2.1        Review and assessment of change. 

3.2.2        Preparation of change action plan.

3.2.3        Monitoring of change, effectiveness check and Closure of the change

3.3              All affected department:       

3.3.1        Review and departmental assessment of Change.

 

4.0              ACCOUNTABILITY:

 Head–QA will be accountable for compliance & implementation of this SOP

5.0              PROCEDURE:

5.1              Initiation of Change Control:

5.1.1        User Department initiates the change control as per the specific requirement.

5.2              Purpose of Change Control:

5.2.1        To prevent unwanted, unapproved, and unintentional changes to validated processes, procedures, methods, equipment, documents, and facilities.

5.2.2        To create a structured procedure to assure all changes are properly specified, designed, reviewed, assessed for risk, approved, and documented to assure

5.2.3        changes will not adversely impact product quality, safety, identity, or purity of drug products

5.2.4        To prevent unauthorized changes

5.2.5        To assure changes are correctly implemented and complies with GMP requirements

5.3              Sources of Changes

Following might be the source of change (Followed by CAPA, if applicable)

5.3.1        Planned improvements, scale-up and development

5.3.2        Deviations / product failures / OOS results / CAPA

5.3.3        Annual Product Quality Reviews

5.3.4        Internal/External Audits

5.3.5        Complaints

5.3.6        Customer requests

5.3.7        Contractor requests

5.3.8        Regulatory requirements or inspections

 

 

5.4              The document issuance requisition shall be approved applicable department head or his designee and authorized by QA head or his designee.

5.5              QA officer/ Executive shall receive the request duly signed with reason for the issuance and issue the change control form (Format No. F/QA-009-01).

5.6              QA executive / officer shall allot the change control number in the change control log as per format No.: F/QA-009-02

A Change Control Number is allotted to the Change Control form. It is allotted as per the following procedure:

The Change Control form shall be numbered as – @@/CC/XXYYY

Where @@ indicates the name of the Proposing department.

Codes for individual department shall be as follows –

Sr. no.	Department	Code No.
0.1	Quality Assurance	QA
2.0	Quality Control	QC
3.0	Engineering	EG
4.0	Personnel & Administration	PA
5.0	Production	PD
6.0	Ware house (RM/PM)	WH
7.0	Finished Goods	FG

 

 

 

 

 

 

 

 

 

 

CC   - Change Control            

XX   - Year of Change Control like 18 for the year 2018.

YYY – Serial Number of the change control

The Change Initiator fills / completes the Change Control Form, Format No. F/QA-009-01 by stating the description of the proposed change, change related to, providing justification for it along with any attachments including drawings, literature, memos / reports that aid in defining the proposed change.

5.7              A proposal for any change shall be initiated in format F/QA-009-01 by the initiator and approved by Head of the initiating department and sent to the Quality Assurance. After QA verification change control circulate to other departments for their comments.

5.8              The following changes / deletion made to existing or introduction of new system / procedure shall be covered under this SOP, but are not limited to:

·               Standard Operating Procedures

·               Specifications and Testing Procedures

·               Validation / Qualification / Methodes

·               Master Plans

·               Site Master File

·               Drawing / Layouts

·               Manufacturing & filling process

·               Batch Size

·               Equipment/Instruments

·               Computer software (GMP concerned)

·               Raw materials / packaging material / bill of material

·               Facilities and utilities

5.9              Following types of changes can initiate the department:

5.9.1        Production department – Change in location of equipment, process, parameter, batch size, cleaning procedure etc.

5.9.2        Engineering department – Change in critical equipment or its parts, or control parameters in utilities, facility, software, building drawing etc.

5.9.3        Process development department – Change in manufacturing formula, Raw material / Packing material finished product, process or control parameters, labeling, etc.

5.9.4        Material – Change in source of any raw material or primary packing material and printed packing material including change in artwork, etc.

5.9.5        Quality Assurance/ Quality control department - Change in documents like Batch Manufacturing Record, formats, SOP, sampling plan, equipment, software, change in specification and STPs etc.

5.9.6        Miscellaneous - Change in disinfectant, cleaning agents and any other material, which directly or indirectly affect the product quality.

5.10          Change Control Procedure shall be applicable only when the change is permanent. Change Control procedure shall not be applicable in following condition:

5.10.1    Where routine servicing or preventive maintenance may be performed and no critical part change.

5.10.2    In case of periodic revision of any document (if there is no change in the document)

5.10.3    Any change in documents that do not have any impact on the quality of product or quality system.

5.11          The proposal shall be reviewed by Head QA to decide whether the change is minor, major or critical. All the Changes like addition to, deletion of, or modification to a system, process, equipment, materials, product or procedures must to be evaluated by Head QA with help of change control team. QA head will Approve/Reject/Return the change control form for more information. Risk Assessment shall perform as per Standard Operating Procedure if required.

 

5.12          Definition:-

5.12.1    Change: - Any addition to, deletion of or modification to a system, process, materials, product or procedure. (List of typical changes & recommended actions consequent to changes are mentioned in format number (F/QA-009-04) & (F/QA-009-03) respectively.

The changes are classified as Minor, Major and critical

5.12.1.1 Minor change – A change unlikely to have a detectable impact on the identity, quality, purity, strength, stability, safety and efficacy or physical characteristic of the product or on critical quality attributes of a system, process, material or procedure. (Example - changes in batch manufacturing record format etc.)

5.12.1.2 Major change - A change that shall have a significant impact on the identity, quality, purity, strength, stability, safety and efficacy or physical characteristic of the product or on critical quality attributes of a system, process, material or procedure. (Example - Change in packing material, change in order of addition of components, mixing parameters in a process.)

5.12.1.3 Critical change - A change that shall have a significant impact on the critical quality attributes of a system, process, material, product or procedure (Example – change in major equipment, change in manufacturing site, etc.).

5.13          Any new system will require complete validation. This can be include, but not be limited to Installation Qualification, Operational Qualification, Performance Qualification, Computer Validation, Cleaning Validations, Method Validation or Process Validation.

5.14          Changes to existing validated systems may require re-validation or additional testing. Review of the change and evaluation of the change for impact on the existing validation is performed by a committee consisting of following departments:

5.14.1    Originating Department Head or designee

5.14.2    Engineering Department Head or designee

5.14.3    Production Department Head or designee

5.14.4    Quality Control Department Head or designee

5.14.5    Warehouse Department Head or designee

5.14.6    Quality Assurance Department Head or designee

5.14.7    Environment , Health and Safety Department Head or designee 

5.15          There are three main categories of people who are involved in any change.

5.15.1    Change Initiator – one who initiates the change

5.15.2    Change Approver – It consist a team of people who shall discuss all the aspects of any change.

5.15.3    Change Authorizer – The change shall be authorized by Head QA /designee.

5.16          Concerned department Head shall send the Change Control Form to the other departments concerned with the change for e.g. Production, Quality Control, Warehouse, Maintenance, Personnel and Administration, Accounts, Marketing or the Quality Assurance Department of Loan Licensee. All these are from team of Change Approvers.

5.17          This signed and dated, Change Control Form shall be forwarded to the QA Head. QA Head shall check that the proposed change falls in which category of change i.e. Minor, Major, and Critical, as described in step 5.5 and whether it is acceptable. QA Head decides whether a joint meeting is required or not. Minutes of Meeting shall be enclosed with Change Control Form. On reaching a decision that the change shall be approved / rejected by QA Head/ designee shall sign and date. If change control is rejected then the rejected change control should be returned to QA dept.

5.18          Every change control Form shall be approved/ rejected within a time frame of 15 days except if approval /Data waiting from the party.

5.19          QA Dept shall evaluate the change with the approved regulatory filings. Based on this assessment, Head QA /Designee shall indicate whether change requires regulatory agency’s prior approval or not. If there shall be a requirement that such a change are to be approved  by regulatory agency, then Head  QA shall forward the necessary details to the respective regulatory agency for approval. Once the approval is received, QA Head  shall attach a copy of the approval to the Change Control Form and decide in co-ordination with other departments that are required to be  referred for the change, whether validation studies / stability studies and marketing approval is required or not. In case validation is required, then shall be informed to initiate the preparation and approval of protocol and subsequent validation studies and forward Change Control Form to QA Head. (Recommended action consequent to changes refer F/QA-009-03).

5.20          Finally, the QA Head shall review the information provided in the Change Control requisition Form along with the recommendation made by other approving authorities. If the change is justified, then accordingly QA Head shall approve the change for implementation. Details of Change Control are recorded in Change Control Log format no. F/QA-009-02. QA Head shall retain the original copy of the Change Control Form to track down the activities. If the change is not justified or incomplete, then Change Control form rejected or returned to initiator for more information with justification by Head QA /designee .The original Change Control requisition Form attached in the change control file with reason for rejection.

5.21          The initiator on receiving the copy of Approved Change Control Form shall arrange for its implementation. If the Change is not approved and clarification is required then he shall contact QA Head and get the things clarified

5.22          Date of implementation of the Change Control shall be decided and mentioned in the form. If required Training shall be conducted for concerned departments before implementation of the approved changes by concerned departments or quality assurance. Record of the training shall be attached to the change control format.

5.23          Every Change Control Form shall be closed within a time frame of 60 days after final authorization except if approval /data waiting from the party.

5.24          QA Head shall review the activities required by the Change Control Form. The Quality Assurance Head shall sign the proposal in the column provided so as to close the change control after ensuring that all necessary activities are performed satisfactorily and finally get the Signatures of QA as intimation to him that Change Control has been completed. After closure, Change Control form maintained by QA department. After implementation QA Dept shall check the effectiveness on the change in case it is applicable after one month and recorded in the change control form, then after change control is finally closed.

5.25          Quality Assurance department shall maintain the completed change control formats and related Documents.

5.26          Trend Analysis of all types of change controls shall be done annually. The trend shall be reported in annual report, which is submitted to the Top Management as per format no.: F/QA-009-05.

5.27          If in any case Change control does not closed within 60 days then give the reason and justification for extension date as per format no.: F/QA-009-01.

5.28          Change Control record should be reviewed regularly.

5.29          Review the Change Control log book on yearly basis with a goal to look for trends as per format no. F/QA-009-05. Inform to QA Head about review findings.

5.30          In case after more than six months the change control has not been closed, the change control shall be closed forcedly at the yearend & a new change control form shall be initiated for the same change.

5.31          Acceptance Criteria:

Every change control form should be closed used in GMP aspects within its specified time period after final authorization.

5.32          Frequency: As per requirement.

6.0              LIST OF ANNEXURE AND FORMATS:

Sr. No.	Title of Format	Format No.
	Change Control Form	F/QA-009-01
	Change Control Log	F/QA-009-02
	Trend of Change controls	F/QA-009-03
	Recommended Actions Consequent to Changes	F/QA-009-04
	List of Typical Changes	F/QA-009-05

7.0              REFERENCES:

7.1              SOP-QA-001

7.2              F/QA-001-01

7.3              SOP-QA-014

8.0              REVISION HISTORY:

Sr. No.	Date	Reason for Revision	Revision No
1.	31/10/2018	New SOP	R0
2.	31/10/2020	Schedule Revision	R1

9.0              ABBREVATIONS:

Sr. No.	Abbreviations	Details
	STP	Standard Testing Procedure
	QA	Quality assurance
	DEPT.	Department
	SOP	Standard operating procedure

 

END OF DOCUMENT

Part-I: INITIATION OF CHANGE CONTROL   Section-A: Initiation of Change control (To be filled by user department)
Initiator Department:		Department Code:
Initiated on:		Target closure date
Type of Change:	Addition:                                      Deletion:                         Modification :

 

1.      CHANGE RELATED TO: (Put a tick mark)

1.1  System		1.2  Document / Record		1.3  Facility
1.4  Product		1.5  Material (RM/PM)		1.6  Utility
1.7  Procedure/Method		1.8  Equipment/Instrument		1.9  Any Other

 

2.      PROPOSED CHANGE: (attach as Annexure if Required)

 

3.      EXISTING PROCEDURE / SYSTEM: (attach as Annexure if Required)

4.      REASON AND JUSTIFICATION FOR CHANGE: (attach as Annexure if Required)

 

Change Initiated By:                                                            (INITIATOR NAME, SIGN & DATE) (INITIATING DEPARTMENT)

Change reviewed and authorized By:         (HOD/DESIGNEE NAME, SIGN & DATE) (INITIATING DEPARTMENT)

 

PART-II: CHANGE CONSENT &  REVIEW
Nominated by (QMS)
Section B: Identification of Cross functional departments whose review required on the basis of approved risk assessment (tick mark) (Note: The change which doesn’t require cross functional department review shall be processed at QA end only after getting approval on risk assessment by QA Head/ designee.)
QA Documentation		P&A
Quality Control		Warehouse
Production (Tab. / Caps. / Oint.)		Engineering
Others   (RA / Customer / Supply Chain   / Safety)
Name:					Sign/Date:
Section C: Evaluation of  initiated change & Risk Assessment by QA In-Charge
Type of Change :                     Major                          Minor                            Critical ­­­Detail Risk Assessment No.: ___________________   Comments: ___________________________________________________________________   Change to be considered :    Yes / No
Name:				Sign/Date:
PART-III: CHANGE CONTROL ASSESSMENT
Section D: IMPACT ASSESSMENT CHECKLIST / AFFECTED ELEMENTS
1.      Quality Assurance (Documentation) Assessment:                         Required     Not Required
i)              Will Change lead to departmental document change?                                        Yes/No/NA ii)             Will Active Product List be revised?                                                                  Yes/No/NA iii)            Will Vendor Qualification be performed?                                                          Yes/No/NA i)              Will Vendor be communicated?                                                                         Yes/No/NA i)              Will Process validation be performed?                                                               Yes/No/NA                                                                            ii)             Will Software validation be done?                                                                      Yes/No/NA iii)            Will Cleaning Validation be done?                                                                     Yes/No/NA iv)           Will Validation Master Validation Plan be revised?                                           Yes/No/NA v)            Will Facility / Utility Qualification be done?                                                      Yes/No/NA vi)           Will FAT/SAT/IQ/OQ/PQ be performed?                                                          Yes/No/NA iv)           Any Other impact : ______________________________________________________            _____________________________________________________________________ In-Charge /Designee comment:   Name: _____________________Sign/Date __________________
2.      Quality Control -Assessment:                                                           Required           Not Required
i)                    Will stability be performed?                                                                                Yes/No/NA i)                    Will Change lead to any departmental document change?                                  Yes/No/NA ii)                  Will Change lead to Stability Study?                                                                   Yes/No/NA iii)                Will Change lead to Preparation / Modification to Spec / STP?                          Yes/No/NA ii)                  Any Other impact : ______________________________________________________   _____________________________________________________________________ In-Charge /Designee comment:   Name: _____________________Sign/Date __________________
3.      Production Department (Tab./Caps./Oint.) Assessment:              Required          Not Required
i)                    Will Change lead to any departmental document change?                                  Yes/No/NA ii)                  Will new Equipment / Instrument/ Component required?                                   Yes/No/NA iii)                Any Other impact : ______________________________________________________               _____________________________________________________________________ In-Charge /Designee comment:   Name: _____________________Sign/Date __________________
4.      Warehouse Department :                                                                  Required         Not Required
i)                    Will Change lead to any departmental document change?                                 Yes/No/NA ii)                  Any Other impact : ______________________________________________________   ______________________________________________________________________ In-Charge /Designee comment:   Name: _____________________Sign/Date __________________
5.      Engineering Department :                                                                 Required         Not Required
i)                    Will Change lead to any departmental document change?                                Yes/No/NA ii)                  Will Equipment / Instrument list be revised?                                                     Yes/No/NA iii)                Will PM / Calibration planner be revised?                                                         Yes/No/NA iv)                Will change lead to modification in Facility / Utility / Equipment?                  Yes/No/NA v)                  Will additional instrument/ equipment/ component be procured?                     Yes/No/NA vi)                Any Other impact : ______________________________________________________   ______________________________________________________________________ In-Charge /Designee comment:   Name: _____________________Sign/Date __________________
6.      Other Department ( __________________ ) :                                 Required         Not Required
iii)                Will Change lead to any departmental document change?                                 Yes/No/NA iv)                Any Other impact : ______________________________________________________   ______________________________________________________________________ In-Charge /Designee comment:   Name: _____________________Sign/Date __________________
Name:			Sign/Date:

 

 

 

 

 

 

 

PART-IV : CHANGE APPROVAL (BY HEAD QA)
Section E: Change Control Approval by Head-QA
Comments:                 Change         Approved         Rejected
Name:	Sign/Date:
Note: Change control action plan as per the assessment shall be tracked as per section F.

 

Section F: Change Action Plan
Sr. No.	Action Plan	Intimated to Department Sign/Date	Target date of implementation	Document No.	Status Completed on	Monitored by (QA) Sign/Date

Note: In case of extension in change implementation respective department shall take the extension from QA head/designee as per Format No: F/QA-009-04

PART-V : MONITORING & CLOSURE OF CHANGE CONTROL AFTER EFFECTIVENESS CHECK
Section G: Monitoring & Closure
i)                    All Action Items have been completed?                                Yes            No                 NA ii)                  All related documents have been prepared?                          Yes             No                NA iii)                Training has been provided to all concerned personnel?      Yes             No                 NA iv)                Reference Copies have been attached?                                  Yes             No                NA v)                  Effectiveness has been checked for the Change?                   Yes            No                NA   QMS Reviewer comment: ____________________________________________________________________________________________ ____________________________________________________________________________________________ ____________________________________________________________________________________________
Name:	Sign/Date:
Review & Closure comments by Head-QA / Designee:
Name:		Sign/Date:

Date of Initiation	Change Control Req. No.	Initiating Dept.	Change Control Req. by (Sign/Date)	Brief Description of Change	Done By(Sign& Date)	Category (Minor / Major)	Status (Approved/ Rejected)	Final Authorization By/on	Closer Date after Effectiveness check		Remark
									Date of Closing	Closed By(Sign)