1.0 OBJECTIVE:
To lay down the procedure for Change Control System.
2.0 SCOPE:
This procedure is applicable for handling of changes pertaining to approved documented procedures, systems, facility, equipment, utility, software and processes
3.0 RESPONSIBILITY:
3.1 Originating Department shall be responsible for initiation of the proposed change and implementation of the approved change.
3.2 Other department shall be responsible for assessment and comment.
3.3 QA department shall be responsible for assessment, approval and monitoring of the change.
3.4 Regulatory affairs department shall be responsible for review, approval of change (as applicable) and intimation to registration authority.
3.5 Head QA shall be responsible for approval of the change control.
4.0 ACCOUNTABILITY:
4.1 Concern Department Head / Head QA shall be accountable for compliance of this SOP.
5.0 ATTACHMENTS:
Change Control Form – Attachment – I
Change control log – Attachment – II
6.0 PROCEDURE:
6.1 If anybody wants to make a change in the existing system and feels that the change will be fruitful in terms of productivity, quality; he / she should discuss with his / her department head.
6.2 If 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.
6.3 The initiating department shall request to QA for issuance of “Change Control Form” through “Document Requisition Form” Format No.
6.4 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
6.5 Part I: Initiation of change control
6.5.1 After receiving of request from initiator department, QA shall start the issuance of change control form as per following procedure.
6.5.1.1 Take a photocopy of change control form and make control copy of change control form.
6.5.1.2 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 running calendar year
YYY Serial number (000 to 999)
6.5.1.3 After change control number allocation, QA writes the date of initiation in change control form.
6.5.2 Record the change control detail with change control number in change control logbook as per Attachment– II.
Note: All the change control shall be Recorded and maintained in the “Change control Logbook” year wise as per Attachment– II.
6.5.3 After login, QA shall issue the change control form to initiator department for execution of proposed change.
6.5.4 Initiator department selects the “Initiator department” in Section 1.0 as per Part-I under Change Control Form Attachment-I.
6.5.5 Initiator department selects the “Change requested for” in Section 2.0 as per Part-I under Change Control Form Attachment-I.
6.5.6 Initiating department shall write the “Details of change (proposed)” under section 3.0 as per Part-I under “Change Control Form” (Attachment-I).
6.5.7 Initiating department shall write reason for change(s) as under section 4.0 of “Change Control Form”. Attach supporting documents as applicable based on which change is proposed.
6.5.8 Initiating department shall mention the documents’ details that will be affected by the change in section 5.0 of “Change Control Form”.
6.5.9 All changes proposed shall be signed by the initiator in the “Change initiated by” column under section 5.0 of “Change Control Form”.
6.5.10 Head of initiating department shall approve the proposed change and shall sign in “Approved by” column under section 5.0 of “Change Control Form”.
6.6 Part II A: Change control consent and review
6.6.1 Initiating department shall forward the proposed change to all concerned departments, if required and wherever applicable.
6.6.2 Head of the concerned departments shall review the proposed change, record the review comments, approve/not approve the change, name sign and date under section 6.0 of Change Control Form in Part II (A).
6.6.3 After receiving the comments from all concerned departments, the initiating department shall submit the “Change Control Form” to Quality Assurance.
6.7 Part II B: Change control assessment by QA
6.7.1 QA shall assess the level of change under section 7.0, Part II (B) of Change Control Form as follows: Type-A: A minor change: A change that has minimal potential to have an adverse effect on identity, strength, quality, 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, 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, potency of a product as they may relate to the safety or effectiveness of the product.
6.7.4 QA shall also perform risk assessment and review the impact of change on related documents, and write the comments under section no 8.0, of Change Control Form.
6.7.3 QA shall recommend the action to be carried out for the proposed change and documents under section no.9.0, of Change Control Form, write the comments and sign in the “Change evaluated by”.
6.7.3 In case the 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 as per section 10.0 Part-II (B) and send back to QA by e-mail or the hard copy and same will be attached with the original Change Control Form.
6.7.4 Regulatory affairs shall review the effect of proposed change against the submitted dossiers.
6.8 Part III: Final approval of change control by Head
6.8.1 Head QA / designee shall evaluate the proposed change against the checklist as per section no.11.0, Part-III of Change Control Form.
6.8.2 Head QA / designee shall evaluate the action points mentioned under section 11.0 of Change Control Form.
6.8.3 Finally Head QA / designee shall approve the proposed change, write his comments and shall sign with date under section no.12.0 of Change Control Form.
6.8.4 After approval of change control from QA Head, QA personnel shall send the approved Change Control Form to all concerned department Heads / designee for executing of the proposed change through electronic means of communications or photocopy of approved Change Control Form.
Note: If a Change Control is pending for approval for more than 30 working days from the date of login, it is the discretion of QA Head or designee to approve or reject the change control.
6.9 Part IV: Verification of implementation & closing of change control
6.9.1 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 approval checklist in section 13.0 of the “Change Control Form”. 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.
6.9.2 Then the Change Control Form is forwarded to Head-QA for closing of the change control. Finally Head-QA shall close the Change control by signing in the “Change closed by” column under section 13.0 of “Change Control Form”.
6.9.3 After Head-QA sign, QA shall close the change control, put the closing date and keep the completed change control form in QA department. And QA shall update the logbook as per Attachment – II.
Note: In case of change in 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.
6.9.4 QA shall be responsible for compilation and archival of the Change control related documents.
7.0 REFERENCES:
Guidance for Industry by USFDA
PIC/S guidelines for GMP
8.0 ABBREVIATIONS:
CCF: Change control form
DQ: Design Qualification
IQ: Installation Qualification
OQ: Operation Qualification
PQ: Performance Qualification
9.0 DISTRIBUTION LIST:
Quality Assurance
Quality Control
Production
Engineering
Warehouse
Human Resource & Administration
Regulatory Affairs
10.0 HISTORY OF REVISION:
| Version No. | Effective Date | Reason for Revision |
