Scribd
Upload
292 views2 pages

Change Control SOP for Pharma Processes

This document outlines the procedure for requesting and implementing changes at a company. It involves 4 main steps: 1. Requesting the change by completing a record sheet and getting approvals. This includes describing the change and reasons. 2. Assessing the change request which includes a risk assessment and approval/denial by a committee. They assign a number and decide on validation needs. 3. Implementing the approved change according to a schedule while revising documents and doing trials. Validation monitors implementation. 4. Evaluating the effectiveness of the change by reassessing risks and recording the change status on a record sheet.

Uploaded by

Mohadese hosseini zabet
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
292 views2 pages

Change Control SOP for Pharma Processes

This document outlines the procedure for requesting and implementing changes at a company. It involves 4 main steps: 1. Requesting the change by completing a record sheet and getting approvals. This includes describing the change and reasons. 2. Assessing the change request which includes a risk assessment and approval/denial by a committee. They assign a number and decide on validation needs. 3. Implementing the approved change according to a schedule while revising documents and doing trials. Validation monitors implementation. 4. Evaluating the effectiveness of the change by reassessing risks and recording the change status on a record sheet.

Uploaded by

Mohadese hosseini zabet
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd

Changes control SOP

Procedure
1- Request for change
1-1- If it is necessary to make a change in a production process, the machine, cleansing, and any change
related to GMP, the change requesting department must notify the validation department of the change
request by completing the record sheet QAR-051-1. This record sheet must be completed by the expert of
requesting department and approved by the department manager.

1.2 The change request must include a description of the change, the reason for the change, and additional
documentation related to the cause of the changes.

1-3-If the implementation of the change requires the revision and modification of the relevant instructions, a
list of them must be provided in the application record sheet.

1-4- In addition, under this section, permission is provided to prepare a copy of the amendment by the quality
assurance manager to present to the person requesting the change to review and correct it by the applied
change.

2- Assessment of the change request


2-1- Request for change after completing the change request record sheet will be announced to the validation
department. The quality engineering department then assesses it. The results of the risk the remarkable
change committee reviews assessments for further review and decision-making on the implementation of the
change, and if necessary, with the presence of representatives from other departments. After concluding the
approval or non-approval of the change, the record sheet QAR-051-2 must be completed.

2-2- It should be noted that during the evaluation phase of the change, the final review is accomplished to
decide on the need for validation operations and related measures.

2-3- After receiving the change request record sheet from the validation department, a number should be
assigned to the desired change by the nature of the change.

2-4- This number is in the form of CC-XXZZZ, where CC indicates the phrase "change control," XX number
of the year of the change request, and ZZZ batch number of change which starts from 001.
3- Implementing change
1-3- After the approval of the change by the relevant committee, the steps of implementation of the change
are performed by the requesting department by the approved schedule, and the validation department will be
responsible for monitoring its implementation.
Changes control SOP

2-3- The documentation department must prepare a review copy of the documents related to the change
before starting the change and submit them to the requesting department to apply the change in the
documents.
3-3- The revision number of the modified SOPs based on the the change will be inserted as a trial review
before the change is approved.
3-4- If the change is confirmed, a new copy with a new review the number will be prepared from SOP with a
trial review number according to the
SOP of preparing copies and distributing valid documents.

4- Evaluation of the effectiveness of change


1-4- After approving the implementation of the change and, if necessary validation operations, the risk is re-
evaluated by the quality engineering department to be demonstrated the effectiveness of the change.
5- After completing the implementation of the change, the status of the change will be recorded in the change
control record sheet number
QAR-051-3.

You might also like