SOP For Change Control | SOP for Change Control Procedure

To lay down the procedure for Change ControlChange control involves evaluating and approving changes in the project baseline scope.


2.1 This procedure applies to the Quality Assurance Department of Xyz.


3.1 Chemists of QA to follow the SOP.

3.2 Head – QA complies with SOP.



Change control is defined as the process of influencing the factors that create change, determining that a change has occurred, and managing the actual changes when they occur. 

4.1.1 Major Change

Change may have an impact on the identity, quality, purity, strength, stability, safety efficacy, or physical characteristics of the product.

4.1.2 Minor Change

 Change, may not have an impact on the identity, quality, purity, strength, stability, safety, efficacy, or physical characteristics of the product.


4.2.1 Raise change control proposal for any permanent change as described in SOP.

4.2.2 The department/section head should submit the proposal for change in a “Proposal for Change / Modification” format. The change or amendment shall be recorded in “Amendment in the document” format.

4.2.3 Change in the manufacturing process, and process control parameters for yield/quality improvement.

4.2.4 Change in manufacturing formula, raw material, and packaging material.

4.2.5 Change in equipment, and utilities.

4.2.6 Change in labeling, and packaging material.

4.2.7 Change in Specifications/Standard Operating Procedures.

4.2.8 Change/up-gradation in data recording/controlling system.

4.2.9 Relocation of facility/equipment.

4.2.10 The head of the originating department shall propose the change to Head – Quality  Assurance, along with supporting data (as applicable).

4.2.11 Details of required changes in other documents (e.g. labels, specifications, SOPs).

4.2.12 Head – Originating department and Head – Quality Assurance shall judge the feasibility of the proposed change based on supporting data and historical data if available.

4.2.13  Quality Assurance shall give the change control number and shall make entries in the “Change Control Record” format.

4.2.14 After the assessment of the change proposal, Head-Quality Assurance shall classify the change as a major or minor category.

4.2.15 The impact of the proposed change shall be discussed and the necessary action plan shall be documented along with the responsibility and target date. Compliance with the action plan shall be reviewed during the approval of the change proposal and closure.

4.2.16 The respective department shall review the change control proposal, as mentioned in the format, “Proposal for Change/ Modification” and the required support shall be attached.

4.2.17 Head–Quality Assurance shall review the change proposal.

4.2.18 based on justification, scientific rationale, and supporting data, the Head – of Quality Assurance and Factory Manager shall approve or reject the change proposal.

4.2.19 Depending on the extent of evaluation and nature of the proposed change, the Head- of Quality Assurance shall forward the approved change proposal to the Factory Manager for approval. 

4.2.20 After approval from the Factory manager, The “Proposal for Change/ Modification” format should be reviewed approved, and authorized by the Head of Quality assurance and the Factory manager.

4.2.21 Before the implementation of the approved change proposal, training shall be given to all concerned personnel. (A copy of such training record shall be attached to the change proposal). 

4.2.22 Approval or rejection of the proposal shall be communicated to the originating department by forwarding a photocopy of the approved/rejected change control proposal.

4.2.23 After the implementation of the change, data (as applicable) shall be collected by the originating department and shall be reviewed by Quality Assurance.

4.2.24 After the evaluation of data, the Head – Of Quality Assurance shall close the change proposal.

4.2.25 Completed change control formats and the associated documents should be maintained as history. 

4.2.26 Minor changes in the Master documents such as spelling corrections, and revision/addition of one or two steps in the SOPs, shall be made through “Amendment” and the corrections shall be regularized during the next revision.

4.2.27 The numbering system for the change control proposal is as follows:

4.2.28 The change control, proposal number shall be given by Quality Assurance after receipt of “Proposal for Change/ Modification” from the respective department.

4.2.29 The change control proposal number will start from “CCP/YYY/201_/01”, and onwards. Where CCP   denotes, “Change Control Proposal” YY or YYY denotes Department Code“201_” denotes Year and followed by/for separation and then the sequence of CCP number in two digits “01”.

4.2.30 The change control origination and details shall be given as per the “Change Control Record (Year…..)” format.

4.2.31  Specifications/SOPs/STPs that are being revised during scheduled review need not be routed through the change control proposal.


CCP:     Change Control Proposal

GTP:     General Test Procedure

PD:     Process Development

QA:     Quality Assurance

QC:     Quality Control

SOP:     Standard Operating Procedure

STP:     Standard Test Procedure
6.1       Nil


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