Change Control Process
Definition:
Change Control: A formal system by which qualified
representatives of appropriate disciplines review proposed changes that might
affect a validated or registered status. The intent is to determine the need
for action that would ensure and document that the system is maintained in a
validated and compliant state.
Procedure:
- Any such changes as described above must be assessed, prior to implementation, for its impact on product quality, current GMP, including Qualification and Validation and the Regulatory Dossier filings, if applicable.
- The procedure outlines a formal, documented review procedure to authorize any change prior to implementation.
- The Functional Departments Viz. Manufacturing, Packing, Engineering QC, Warehouse etc. must initiate proposals for changes, if any with a reason / rationale for such changes.
- They shall be duly filled up as per need and the same shall be sent to QA for further coordination.
- The change is documented using the “Change Proposal Form” This form should also incorporate the description of the change and the procedure that was prevalent thus far. The proposer shall sign the proposal duly authorized by the Departmental Head.
- QA shall incorporate the date and reference number of each Change Control Format chronologically upon receipt of the same and maintain the original form along with the index with them.
- The changes must be initially reviewed and assessed by Quality Assurance. They shall decide which functions need to be involved to ensure an adequate review, evaluation and assessment of the proposed change. The change is assessed using the Change Assessment Form
- The documents requiring revision or modification and any other associated studies required shall be ticked against the relevant slots in the Checkbox next to the Document/ Study type.
- Proposed changes must be justified by adequate supporting data, including Stability, Qualification or Process Validation data where appropriate. In this regard the effects or possible effects of a change on the DRA aspects (viz. Registration related) shall be examined.
- At this stage, a statement shall be made by QA as to whether the concerned Department proposing the change can go ahead with the same or if the Change is required to be kept in abeyance. This intimation shall be passed on to the Change proposer along with a copy of the Change Assessment Form, if required.
- After the recommendations of QA, as mentioned in the Change Assessment Form, the concerned departments who are involved with the change` shall go through the “Change Evaluation & Review Form”
- In this page, data shall be reviewed and evaluated by all concerned including Engineering, Warehouse, if applicable. The dates on which the documents or studies are completed shall be mentioned on this page.
- Approved changes shall be supplemented with the likely date of implementation of the Change, effective Batch Nos. etc.
- In case of Document Changes, a chronological Change history shall be maintained along with the respective document. All finally approved change controls should be followed by adequate communications to all concerned. Appropriate training should be conducted and documented with respect to the implementation of the change, if applicable.
Change Control Ref.
___________ Receipt Date ___________ QA Signature______
CHANGE PROPOSAL FORM
(To
be filled in by the dept. proposing the change and handed over to
Site QA for co-ordination of further Action)
1.
CHANGE PROPOSED BY DEPARTMENT ____________________________
2.
PRODUCT
PROCESS/EQUIPMENT/UTILITY/FACILITY/DOCUMENT/MATERIAL _________________
___________________________________________________
3.
PROCEDURE SO FAR
______________________________________________________
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4.
DESCRIPTION OF CHANGE ______________________________________________________
5.
REASON / RATIONALE FOR CHANGE
WITH ENCLOSURES, IF ANY ____________________
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NAME
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DEPARTMENT
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SIGNATURE
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DATE
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Change
proposed By
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Authorized by
Departmental Head
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….. Note: The Master Document is duly authorized
Change Control Ref .
___________ Receipt Date ___________ QA Signature______
CHANGE ASSESSMENT FORM
(To be reviewed
by QA and QA to send for review to concerned departments as per applicability)
THE FOLLOWING ACTIVITIES SHOULD BE CONDUCTED /
DOCUMENTS PREPARED IN CONNECTION WITH THE PROPOSED CHANGE:
PLEASE TICK
WHICHEVER APPLICABLE:
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Sr.No
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ACTIVITY/ RELATED
DOCUMENT
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DOCUMENT TYPE WITH
REMARKS
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1.
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Product
Development Report
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2.
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Master Formula
Record / Batch Manufacturing Records/ Batch Packaging Records / Standard
Operating Procedure
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3.
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Analytical
Specifications/Test Methods
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4.
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Stability
Report
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5.
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cGMP Audit
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6.
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Analytical
Method Validation
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7.
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Process
Validation
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8.
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Cleaning
Validation
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9.
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Qualification
Reports
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10.
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Validated
Drawings
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11.
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Change in Regulatory
Dossiers ( DRA /Registration issues)
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12.
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Prior
Permission of State Drug Control Authority
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13.
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Approved
Supplier List Revision
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14.
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Notification
to State Drug Control Authority
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15.
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Computer
Validation
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16.
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Others
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Change Control Ref .
___________ Receipt Date ___________ QA Signature______
CHANGE EVALUATION & REVIEW FORM
(To
be reviewed by representatives of concerned departments along with QA)
THE FOLLOWING DOCUMENTS / STUDIES / DRAFT DOCUMENTS
HAVE BEEN PREPARED ON:
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Sr. No
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DOCUMENT TYPE
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REMARKS
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COMPLETED ON
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1.
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Product
Development Report
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2.
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MFR/BPCR/SOP
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3.
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Analytical
Specifications/Test Methods
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4.
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Stability
Report
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5.
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cGMP Audit
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6.
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Analytical
Method Validation
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7.
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Process
Validation
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8.
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Cleaning
Validation
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9.
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Qualification
Reports
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10.
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Validated
Drawings
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11.
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Change in
Regulatory Dossiers
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12.
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Prior
Permission of State Drug Control Authority
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13.
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Approved
Supplier List Revision
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14.
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Notification
to State Drug Control Authority
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15.
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Computer
Validation Issues
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16.
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Training
Records
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17.
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Others
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Change Control Ref . ___________ Receipt Date ___________ QA
Signature_____
CHANGE APPROVAL FORM
(To
be coordinated by QA)
Review
& Evaluation of Supportive Data & Approval of change
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Department
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Comments
w.r.t.
Approval
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Signature
& Date
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Manufacturing |
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Packing |
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Quality Assurance |
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Quality Control
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Engineering
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Warehouse
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Product Development
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Final
Approval by Head Quality Assurance (Site or Corporate or Region)
Remarks
Regarding Approval:
Signature
& Date :
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