To lay down the procedure for establish & implement procedure for change control system.
1.0 PURPOSE
1.1 To lay down the procedure for establish & implement procedure for change control system.
2.0 SCOPE
2.1 This procedure is applicable for the implementation of change control system in Production, Quality Control, Quality Assurance, Warehouse, Safety and Environment, Engineering, Purchase, Electronic Data Processing (EDP) and Personnel and Administration departments.
3.0 RESPONSIBILITY
3.1 Originating Department for initiation and implementation
3.2 QA department for assessment & approval.
4.0 ACCOUNTABILITY
4.1 Manager - Quality Assurance
5.0 PROCEDURE
5.1 DEFINITION OF CHANGE CONTROL: Change control is a system that control change by
5.1.1 Identifying ownership of the change
5.1.2 Allowing for review and approval of the change.
5.1.3 Preventing changes that could adversely affect product quality or conflict with registration or regulatory requirement.
5.1.4 Providing an assessment of change and monitors the impact of change.
5.2 OWNERSHIP OF THE CHANGE
5.2.1 The ownership of the change is with the head of the department, who is responsible for initiating the change in change control initiation Form as per Annexure-I.
5.2.2 Identification of ownership of the change & consent to be taken from the other department is mentioned in Change Initiation Matrix as per Appendix-I.
5.3 INITIATION OF CHANGE CONTROL:
5.3.1 Change control initiator shall describe the following in change control initiation form as per Annexure-I.
5.3.1.1 Name of Initiator department and Name of the product and stage of production if applicable in the section 1.0
5.3.1.2 Code of change in the section 2.0 as per Appendix-I.
5.3.1.3 The changes proposed in the section 3.0
5.3.1.4 Identification of changes either temporary (with period) or permanent.
5.3.1.5 Reason for the change in the section 4.0 as per section 4.3.4.
5.3.1.6 Tentative date of change to be implemented with batch number (if applicable) in the section 5.0
5.3.2 Initiator department shall attach supporting document (if applicable) based on which, change is proposed.
5.3.3 The following are types of documents, to be attached with Change control Initiation Form, But not limited to:
5.3.3.1 R&D Laboratory data in case of manufacturing process change,
5.3.3.2 Recommendation from other agencies /departments,
5.3.3.3 Past trend data
5.3.3.4 Audit observation
5.3.3.5 Change in Regulatory norms / guidelines.
5.3.4 The type of reason may be as follows, but not limited to
5.3.4.1 Regulatory requirement
5.3.4.2 Good manufacturing practices implementation / enhancement
5.3.4.3 Quality improvement
5.3.4.4 Capacity enhancement
5.3.4.5 Introduction of new product in existing facility
5.3.4.6 Cost reduction
5.3.4.7 Automation
5.3.4.8 Aging of Facility
5.3.4.9 To manage the unavoidable situation
5.3.4.10 Market requirement
5.3.5 The Head of the initiator department shall sign in the section 6.0 of change control initiation Form as per Annexure-I and send it to Regulatory Affairs department.
5.3.6 Regulatory Affairs department shall review the proposed change and give remarks whether the change can be recommended or not.
5.3.7 Regulatory Affairs department shall hand over change control initiation form to Quality Assurance department.
5.3.8 On receiving the change control initiation form, Quality Assurance shall put a unique serial number on change control initiation form and enter the change detail in change control log as per Annexure-IV.
5.3.9 Change control log shall be maintained department wise as per Annexure-IV.
5.3.10 Change control numbering system is given below;
CC / XX / 3001
Serial number
Last digit of running calendar year
Initiator Department Code (Refer SOP xxxxx)
Format title prefix
5.3.10.1 Serial number will be generated from the change control register as per Annexure-IVmaintained by Quality Assurance departments at unit level.
5.3.11 If the change proposed is not recommended by Regulatory Affairs department, QA shall reject the change, record the change detail in the change control log and inform the initiator department
5.3.12 If the change proposed is recommended by Regulatory affairs department, Quality Assurance department shall send the executed change initiation form to other concern department as mentioned in Appendix-1 to get their consent
5.3.13 Head of the concerned department or his deputy shall write their remarks to indicate the change feasibility or impact assessment, in the section 7.0 of Change Control initiation form as per Annexure-I.
5.3.14 Finally the executed change initiation form shall return back to the Quality Assurance department.
5.3.15 Head of Quality Assurance department shall write the recommendation statement in the section no. 8, whether the change is recommended or not.
5.4 EVALUATION BY QUALITY ASSURANCE DEPARTMENT
5.4.1 Quality Assurance person shall review the proposed change
5.4.1.1 To assess the impact on current documents.
5.4.1.2 To assess the impact on the Quality attributes of the product.
5.4.2 On review QA shall fill the section 1.0 and 2.0 of the change control Evaluation form as per Annexure –II for the list of documents to be revised & action to be taken before approval of change.
5.4.3 Appendix –II and III contains facility and process/Product related change analysis matrix to guide the QA reviewer to select the action required before change approval. However this will not limit the reviewer to restrict this review process within the guideline because of the generic nature of the matrix.
5.4.4 Quality Assurance department shall send the inter office communication to intimate the initiator and / or the concern department about the recommendation of the proposed change and action required for the final approval of the change. Format for the IOC is given in the Annexure V.
5.4.5 Initiator and /or the concern department head or deputy shall response with in the 72 hours after receiving the IOC.
5.5 CHANGE APPROVAL
5.5.1 QA shall review the revised documents and result of action and record the comments on the section 1 of change control approval form as per Annexure –III.
5.5.2 If the change is required to be approved by the Regulatory Affair, QA shall send the change approval form along with initiation and evaluation form to the Regulatory Affairs Department for review and approval.
5.5.3 Regulatory Affairs Department shall write comments for the requirement of the regulatory submission required for the approval of the change.
5.5.4 If change requires submission of pre-approval supplement, Regulatory affairs will submit the same and the change will be implemented after obtaining the regulatory approval.
5.5.5 In other case as applicable regulatory affairs shall file Change being effected supplement or include the change in Annual Update.
5.5.6 Change will be implemented after final approval by the head of QA department.
5.6 CLOSING OF CHANGE CONTROL:
5.6.1 On approval of change control, it is the responsibility of Quality Assurance to verify that whether the change is implemented as per the proposal and verification shall be documented in section 2.0 of the change control Approval form as per Annexure-III.
5.6.2 QA department is responsible to verify that all the documents as recommended in the change control document are revised and come under effect.
5.6.3 QA shall also ensure that all controlled Copies/ Reference copies of earlier version are destroyed and Master document is stamped with “OBSOLETE FOR REFERENCE ” and filed in proper location.
5.6.4 If the change verification is satisfactory Quality Assurance shall conclude the change control and close the same.
5.6.5 In case of temporary changes, QA shall ensure that old system is back in place after recommended period of change and close the temporary change control.
5.6.6 If change is rejected change will be closed by QA department.
5.7 DOCUMENTATION
5.7.1 Quality Assurance shall log the change control in a register where following information shall be recorded as per Annexure-IV.
5.7.1.1 Change control Number
5.7.1.2 Change code
5.7.1.3 Date of initiation
5.7.1.4 Department name
5.7.1.5 Proposed change
5.7.1.6 Whether approved/Rejected i.e. status of change control
5.7.1.7 Date of closing
5.7.2 QA shall compile all executed forms of change control and file department wise.
5.7.3 After closing of change control, a complete set of change control document shall be send to the change initiator department with a controlled seal, by QA.
END OF DOCUMENT
Change control, quality assurance, implement procedur,
