| Procedure of Change Control |
1.0 OBJECTIVE To lay down the procedure for initiation, review, approval, rejection and implementation of change control. 2.0 SCOPE 2.1 This procedure is applicable for changes directly or indirectly related to manufacturing, packing, testing and storage of products manufactured. 3.0 RESPONSIBILITY • Officer/Executive – Concerned Department shall be responsible for: Initiating change control proposal Providing the supporting document /data for the proposed change control Preparation of Risk Assessment, if required. Initiation and preparation of supplemental change control. • Officer or above of Quality Assurance shall be responsible for: Assigning Change Control Number to the Change Control Proposal Reviewing supporting document /data Maintaining & Up-Keeping all the records related to change control Evaluation of supplemental change control. • Concerned Head of Department shall be responsible for: Review of the supporting documents/data for adequacy Evaluating impact of proposed change on their existing systems. Review the Risk Assessment, if required. Review of supplemental change control. • Head QA shall be responsible for: Approval of proposed Change Control. Approval of supplemental change control. Provide the further recommendation, if required. Assessing if the change will adversely impact the safety, identity, strength, purity or quality of the drug product during shelf life and also regulatory impact. 4.0 ACCOUNTABILITY Head Quality • Overall accountable for compliance of the procedure. 5.0 PROCEDURE 5.1 Change – Any addition, deletion or modification to any approved procedures, document, process, materials, product, equipment and utilities is defined as a change. 5.2 Officer/Executive of the concerned department shall request QA department for issuance of change control proposal form (Refer Format No. XXX). 5.3 Based on request Quality Assurance personnel shall issue the photocopy of change control form and assign a Change control number. The Change Control Number along with the brief description of change shall be recorded in the Change Control Logbook (Refer format No. XXX). 5.4 The numbering system of change control consist of 10 alphanumerical characters as: CCP/ YY / NNN mentioned below: Where, CCP : Stands for Change Control Proposal YY : Stands for last two digit of calendar year, e.g. for 2023 is 23, 2024 is 24 and so on. NNN :Stands for sequential serial number of the change control initiated in the calendar year, e.g. 001, 002, 003……….and so on. 5.5 Officer/Executive of the change initiating department shall enter the details of change in the CCP form as follows: • Product, document, facility, equipment, process or any others in which the change is proposed. • Existing practice/document /process being followed to be recorded. • The proposed change request shall be described in detail in the space provided. • The reason/justification for proposed change shall be mentioned in the space provided. Reference can be made to the supportive data as appropriate. • The evaluation of change shall be mentioned. • The initiator shall attach the documents required for approval, based on the nature of changes. • Change Control shall be initiated prior to procurement of Equipment’s/Instruments. 5.6 The initiator shall forward the CCP to Head of initiating department along with all relevantdocuments. The Head of initiating Department shall evaluate the impact assessment of proposed change. 5.7 On completion of evaluation head of the initiating department shall forward the change control proposal to QA department. 5.8 Executive or above of QA shall review the change proposal along with all relevant documents and evaluate the impact of proposed changes. 5.9 The impact assessment/evaluation for the proposed change shall be done for the following but not limited to: • Impact on Master Documents – Batch Manufacturing Record/Batch Packing Record/Bill of Material /Master Formula/Standard Operating Procedure/ Validation Master Protocol /Validation Protocol/ Site Master File/Stability Protocol/ Layouts/Drawings. • Validation/Calibration status • Stability of the Product • Specifications/Analytical Test Procedures • Technical Agreement with the customer/ Supplier • Annual update/Supplements/Amendments • Marketing Authorization Application • Others, as applicable 5.10 After the review, Executive or above of QA has to classify the change on the basis of impact of proposed changes. 5.11 Classification of Change Control 5.11.1 Based on the nature of proposed changes and their impact they are classified as below: >Major Change Changes, which may have direct impact upon the product identity, quality, purity, strength, stability, safety and efficacy or physical characteristic of the product. e.g., Change in formula of product, change in validated batch manufacturing process, equipment change, change in test methods, calibration procedures, change in any other documents which have been submitted to any Regulatory authority/ customers, Change in Shelf-life etc. Changes, which may have direct impact on performance of man, material, procedure, equipment, environment and utility and which further may have direct impact on product manufacturing, testing and distribution procedure. Change, which may have regulatory impact and may require variation filling. >Minor Change Any changes which do not fall in the category of major changes are categorized as minor changes. After evaluation and classification, Executive or above of QA shall circulate the CCP to the other head of departments who may get impacted by the proposed changes. Risk assessment of all Major change control shall be performed after raising the change control. If any, Formulation, equipment’s and process are identical and packing pattern may different during manufacturing of product then existing risk assessment shall be considering for manufacturing of product and acknowledge the details of said risk assessment in respective change control. On receipt of CCP with comments from all relevant departments, Executive or above of QA shall forward to Head QA for final review and approval/ rejection of the proposed changes. All Major CCPs pertaining to a PL (Product License) Holder product shall be sent to PL Holder/QP (Qualified Person) for approval and recommendations. Minor CCPs pertaining to PL holder products shall be sent to PL holder for information purpose. The Head QA shall evaluate the CCP considering the necessity for change and any other cGMP aspect included but not limited to the following: Does the change affect the regulatory/cGMP compliance? Do the changes in any document require any further changes in associated documents, Processing equipment’s, Instruments or any other testing requirements. Whether all the concerned people are aware of the effects of the change on their current processes/operations. The Head QA shall approve/reject the change control proposal,QA shall notify the change to all the concerned people with proposed effective date for implementation of change in case if proposal is approved. All CCPs shall be closed within 3 months except those which are having impact on facility or equipment where implementation may take more than 3 months, these change control shall be closed based on pre-assigned TCD. In case of change control activities not completed within specified timeline,change control timeline shall be extended based on the concern department head request Head of concern department shall initiate the extension for closure of change control and provide the appropriate reason or justification to extend the closure of change control with revised TCD as per format no. XXX. Action Plan & Implementation Once the change is implemented, Executive or above of Quality Assurance Department shall review the implemented changes with respect to following (but not limited to these). Result of Validation Study/ Experimental Batch Result of Stability study Result of trials carried out byProduction / QC Prepared/updated documents Training conducted (if applicable) Any other activity done After implementation ofchange pertaining to a PL (Product License) Holder, relevant documents shall be sent to PL Holder/QP (Qualified Person), If required. Post impact assessment:After implementation of action items, re-evaluation of CCP shall be performed by Executive or above of QA for verifying the changes implemented. If any discrepancy or any action plan have been missed out during previous impact assessment, then Executive or above of QA shall mention the missed details in CCP form in section post impact assessment (Refer format no. XXX)for implementing the missed action plan. Action plan missed out at the time of implementation of change control proposal. Missed action plan shall be completed prior to closure of change control. Details of proposal of supplemental change control shall be also recorded during post impact assessment, if supplemental change control initiated. CCP shall be closed after implementation of all action plan. The filled CCP shall be maintained five years from date of closure of change control of the manufacturing site. First Impact Results: After implementation of changes proposal, first impact results shall be evaluated against each action item as per proposal, after execution of action items. In case of first execution activities is required long duration more than TCD, then closure of change control shall be carried out after verification of revised documents. Trend Analysis: A trend of Change Control shall be prepared on half yearly and yearly within 30 working days in graphical representations as per template of format XXX. Following aspects shall be included during trend analysis but not limited to Department Category – Major/Minor Facility wise Overdue status – Open/Closed Type – Documents/Equipment’s/Facility/Method etc. Summary and conclusion. Procedure for handling of supplemental changes: If any further changes are required after approval of change control, then Supplemental Change Control Proposal form (Format: XXX) shall be raised with reference of existing change control. Concern department shall write the additional changes in supplemental change control and obtain the signature from User Department. QA will evaluate the supplemental proposal along with its impact and provide recommendation, if required. If there is any impact on the cross functional department then Supplemental change control are not allow to execute the activities. Finally, QA Head/Designee shall be Approved/Rejected the proposed changes as per Supplemental Change Control Proposal form. |
