Change Control in Pharma

OBJECTIVE:

To lay down the procedure for Change Control System.

PROCEDURE:

If anybody wants to make a change in the existing system and feels that the change will be fruitful in terms of productivity, and quality; he/she should discuss it with his / her department head.

If the department head feels that it is required, then they should initiate the change through the Change control form.

Note: The ownership of the change is with the head of the originating department who is responsible for initiating the change.

The initiating department shall request to QA for issuance of a “Change Control Form” through the “Document Requisition Form.

The change control form consists of the following parts

  • Part-I: Initiation of Change Control
  • Part II (A): Change control consent and review
  • Part-II (B): Change control assessment by QA
  • Part III: Final approval of change control by Head QA
  • Part IV: Verification of implementation and closing of change control

Part I: Initiation of change control

After receiving of request from the initiator department, QA shall start the issuance of the change control form as per the following procedure.

Take a photocopy of the change control form and make a control copy of the change control form.

QA allocates the change control number in change control form as given below:

CCF-XX-YYY

  • CCF    Change control form
  • XX      Last two digits of the running calendar year
  • YYY   Serial number (000 to 999)

After the change control number allocation, QA writes the date of initiation in the change control form.

Record the change control detail with the change control number in the change control logbook.

Note: All the change control shall be recorded and maintained in the “Change control Logbook” year-wise.

After login, QA shall issue the change control form to the initiator department for execution of the proposed change.

The initiator department selects the “Initiator department”.

The initiator department selects the “Change requested for”.

Initiating department shall write the “Details of change (proposed)”.

Initiating department shall write the reason for the change(s). Attach supporting documents as applicable based on which change is proposed.

The initiating department shall mention the documents’ details that will be affected by the change.

All changes proposed shall be signed by the initiator in the “Change initiated by” column.

The Head of initiating department shall approve the proposed change and shall sign in the “Approved by” column.

Part II A: Change control consent and review

Initiating department shall forward the proposed change to all concerned departments, if required and wherever applicable.

The Head of the concerned departments shall review the proposed change, record the review comments, approve/not approve the change, name sign, and date.

After receiving the comments from all concerned departments, the initiating department shall submit the “Change Control Form” to Quality Assurance.

Part II B: Change control assessment by QA

 QA shall assess the level of change as follows:

  • Type-A: A minor change: A change that has minimal potential to have an adverse effect on the identity, strength, quality, and potency of the product as they may relate to the safety or effectiveness of the product.
  • Type-B: A major change: A change that has a moderate potential to have an adverse effect on the identity, strength, quality, and potency of the product as they may relate to the safety or effectiveness of the product.
  • Type-C: A critical change: A change that has a substantial potential to have an adverse effect on the identity, strength, quality, and potency of a product as they may relate to the safety or effectiveness of the product.

QA shall also perform a risk assessment and review the impact of change on related documents, and write comments.

QA shall recommend the action to be carried out for the proposed change and documents, write the comments and sign in the “Change evaluated by”.

In case approval from any specific regulatory agency is required, QA shall forward the filled scanned Change Control Form to the Regulatory Affairs Department by e-mail and RA shall co-ordinate with concerned regulatory authorities and shall give the comments/approval as per their comments on scanned Change Control Form and send back to QA by e-mail or the hard copy and same will be attached with the original Change Control Form.

Regulatory affairs shall review the effect of the proposed change against the submitted dossiers.

Part III: Final approval of change control by Head

Head QA / designee shall evaluate the proposed change against the checklist.

Head QA / designee shall evaluate the action points mentioned.

Finally, the Head QA / designee shall approve the proposed change, write his comments, and shall sign with the date.

After approval of change control from the QA Head, QA personnel shall send the approved Change Control Form to all concerned department Heads/designees for executing the proposed change through electronic means of communication or photocopy of the approved Change Control Form.

Note: If a Change Control is pending approval for more than 30 working days from the date of login, it is the discretion of the QA Head or designee to approve or reject the change control.

Part IV: Verification of implementation & closing of change control

On the approval of change control, it is the responsibility of Quality Assurance to verify whether the change is implemented or not as per the proposal and verification shall be documented as per the approval checklist. Only after satisfactory implementation of the change and all documents or activity mentioned in the change control form is properly closed, then only QA personnel shall close the change control by signing and putting the date in the “Change monitored by” column.

Then the Change Control Form is forwarded to Head-QA for the closing of the change control. Finally, Head-QA shall close the Change control by signing in the “Change closed by” column.

After the Head-QA signs, QA shall close the change control, put the closing date, and keep the completed change control form in the QA department. And QA shall update the logbook.

Note: In case of a change in the Manufacturing Process or a new vendor, trial batches with proposed changes should be taken & kept on stability to see that the proposed change does not affect the product during its shelf life. After getting the results, the proposed change can be incorporated.