Department | Quality Management | Document no | QMS-125 | ||
Title | Change Management System | ||||
Prepared by: | Date: | Supersedes: | |||
Checked by: | Date: | Date Issued: | |||
Approved by: | Date: | Review Date: | |||
DOCUMENT OWNER
Technical/Quality Manager
PURPOSE
This procedure provides a standardized procedure and framework for initiating, authorizing, planning and implementing any change to a GMP system.
Product Change Management requires that all planned permanent changes that have the potential to impact on regulatory filings or the quality of an active pharmaceutical ingredient or drug product must be evaluated, reviewed and approved. It also requires that the site procedure must include provision for effectively tracking all quality and regulatory changes and provide a mechanism for review and approval by the Site Quality Team for all changes.
The Environmental Health and Safety (EH&S) Management of Change requires that facilities must develop, implement and maintain a written program to evaluate and address the EH&S implications of facility change, both for existing operations and for new or expanded facilities. It is also required that the management of change process must ensure that changes do not adversely affect site’s:
a. Protection of human health and the environment;
b. Responsiveness to Community concerns;
c. Efficient use of resources;
d. Full compliance with applicable EH&S laws and regulations; and
e. Full compliance with all requirements of these EH&S Guidelines
SCOPE
All departments requiring a planned permanent change to a GMP system are bound by the rules set out in this procedure. This SOP applies for any change that directly or indirectly affects product quality, regulatory filings, data integrity or environmental health and safety.
The following changes are outside the scope of this procedure:
a. Minor documentation changes
b. Unplanned or temporary changes
c. Product Change Proposals (PCP) and Product Change Requests (PCR)
d. Routine artwork updates
e. Changes initiated by the site for Contract Manufacturers – in this case, GMP Site will request the Contract Manufacturer to initiate a change in their own system on GMP Site’s behalf. This process will be managed in accordance with “Change Management of Contract Manufactured Products”.
RESPONSIBILITY
4.1 All colleagues in the GMP facility are responsible for ensuring that this procedure is adhered to and that all proposed changes are formally requested, assessed and approved prior to implementation.
4.2 Within the Change Management System, certain roles can be defined that should carry specific responsibilities. These are clearly defined in the table below:
Role | Responsibilities |
Change Requestor | – Initiating the change by creating a Change Request; – Specifying the details of the change, including a description of the proposed change, a justification and an estimated completion date; – Obtaining agreement from the Department Manager of the area affected by the change; – Ensure adequate supporting data is provided to facilitate approval. |
Department Managers | – Assessing any Change Request initiated for their area to ensure that it is value adding and that all supporting (System Owners) information has been provided; – Approving each change for implementation. |
Change Request Coordinator | – Administering the Change Management procedure; – Monitoring the Change Request created; – Advising the Plant Technical Team when changes are ready for review; – Coordinating the Plant Technical Team Meetings; – Reviewing the deliverables for completed Change Request; – Closing the Change Request record; |
Plant Technical Team | – Attending the periodic meetings; – Conducting the Impact Assessment for each Change Request; – Recommending the deliverables and activities required to support the implementation of each change; – Assigning a Project Leader and Project Team. |
Quality Assurance/Compliance Manager | – Approving each change for implementation in the Pre-Approval stage of Change Request; – Approving completion of each change in the Post-Approval’s stage of Change Request; |
EH&S Coordinator | – Approving each change for implementation in Pre- Approval’s stage of Change Request. |
Project Leader | – Coordinating the project team activities to meet required deliverables as assessed in the impact assessment; – Extending the Estimated Completion Date of the Change Request when required using Overdue Change Request Notification; – Compiling the supporting documents to address deliverables required; – Notifying the Change Request Coordinator when all deliverables are complete and change can be closed. |
Project Team Members | – Completing all activities required to successfully document and implement the approved change. |
PROCEDURE
5.1 First discuss the proposal with the manager of the area affected by the change to determine if the change is feasible.
5.1.1 Initiate a Change Request using appropriate Change Request Form. (For example, Form-365 Master Document Change Control Form)
5.1.1.1 Change Request Form
– Title/Short Description – Enter a short description of the Change Request. This description must be direct and relevant to the content of the record. A short change description is required. For example: “Reduction of calibration frequency for HPLC 453”.
– Responsible Person – Identify the responsible person to coordinate the implementation of the Change Request.
– Due Date – Identify a realistic due date for the Change Request.
– System Owner – Identify the owner of the business area.
– Department(s) Affected – Enter the relevant department(s) of impact.
– Area(s) Affected – Enter the relevant area(s) of impact.
– Urgency – Enter either Emergency/Critical, Expedited/Urgent or Standard/Routine to determine the priority. A critical change will potentially affect quality, regulatory and/or safety.
An urgent change will improve cost, customer service and/or marketing ability. A routine change will improve productivity and efficiency.
Note: Emergency/Critical approvals will only be granted in exceptional circumstances and should not be considered a normal part of the change management.
– GMP Change – Enter Yes or No, depending on the impact on GMP.
– Change Type – Enter either Major or Minor. A minor change is a routine change of no product significance. These changes do not require re-validation. A major change may impact purity, safety and efficacy of a product. It may involve a change to a critical utility (e.g. HVAC, plant surveillance system, sterile compressed air, etc.) or process that requires re-validation. Major changes usually require regulatory approval before implementation.
– Impact Assessment Required – Enter Yes or No. Write the rationale for the choice.
– Change Classification – Write either permanent / temporary changes to be made.
– Description of Change, Reason for Change and Recommended Actions – a detailed description of what the change is, why the change is required and how the change will be completed.
– Attachment(s) – Attach any relevant supporting files/documentation, risk assessments, feasibility studies, material specifications, registration documents etc., if applicable.
– More Information– Specific details of the change to be completed for items affected; Product, Documentation, IT systems, Process, Material, Packaging/Labelling/Artwork and Facilities / Utilities /Equipment. Status of the items can be updated throughout the life of the change.
5.1.2 Initiator to sign and date when all fields have been completed.
5.1.3 The Change Request Coordinator and the EHS approver must pre-approve the Change Request.
5.1.4 The Change Request Coordinator should prepare an agenda and site technical review team which new changes have been submitted for review and route the changes for impact assessment.
5.2 Assessing / Approving a Change Request
5.2.1 Routine and Standard Changes
5.2.1.1 Each member of the site technical review team should review the agenda and complete the Impact Assessment for each of the new changes.
5.2.1.2 Each member should consider the GMP and EH&S impact of the change and the deliverables required by their department, in line with the guidelines in the Impact Assessment section of the Change
Request. They should also identify any concerns or special considerations regarding the approval and implementation of the change. This assessment should also take into consideration any impact to regulatory commitments.
5.2.1.3 At the site technical review team meeting, the team should discuss any issues that arise during completing the Impact Assessment of the Change Request. The deliverables will be determined and recorded at this time.
5.2.1.4 The status of the change will be determined in the Pre-Approval stage with reference to the table below:
Status | Required Details |
Approved | – Project Leader assigned to coordinate the activities – Project team members assigned to execute the activities – The recommended deliverables required supporting the change have been determined – Any special comments have been considered and documented in the pre-approval comments stage. |
More Assessment Needed | – Any additional information required in order to assess the change and the initiator is responsible for needed collating that information – A date for the status of the change to be reassessed |
Cancel | – Write the reason and any comment for the cancellation in the Pre-Cancel Approval stage |
5.2.1.5 Once the status is determined in the Pre-Approval stage, a date and meeting number is will be recorded in Pre-Approval comments section by the Change Request Coordinator.
5.2.1.6 Approval to proceed is granted once EH&S and Quality Operations complete their approval under the Pre-Approval section.
5.2.1.7 A Change Request where More Assessment is needed should be returned to the initiator to provide. The Change Request Coordinator can do this on the Change Request record. Once the requested information has been collated, the form should be re-submitted for assessment. (Return to Section 5.1.3)
5.2.1.8 When a Change Request is cancelled the Change Request Coordinator must endorse the cancellation and archive the cancelled form appropriately.
5.3 Implementing a Change
5.3.1 The assigned Project Leader must call a project meeting with the team to fully scope the activities required to implement the change. The team should assign suitable actions and realistic time lines for all activities.
5.3.2 The Project Leader should then co-ordinate the activities that have been identified as required for the Change Request and ensures that the change is implemented prior to the Due Date.
5.3.3 Once a change is open past its Due Date it is considered to be overdue. If for any reason, an extension of the Due Date is required, this must be formally requested and approved by completing “Overdue Change Request Notification”.
5.3.4 The relevant members of the assigned project team should complete each assigned activity, in line with the relevant guidelines and procedures in their departments.
5.3.5 Upon completion of the assigned activities, the team should complete/add details to specific section in about the implementation or supporting documentation or work that was carried out regarding the change requested.
5.3.6 Each team member should clearly reference any documents that were generated by their department, or attach evidence of the activity completion to the File Attachment(s) to show that all recommended deliverables were completed or assessed. All attachments should be clearly labeled with the Change Request number and an Attachment number for traceability; e.g. PR XXXX, Attachment 1.
5.3.7 In the event that a recommended deliverable is no longer needed, the team member responsible for its implementation should document their assessment and justification in the ‘Comments’ section in ‘Change Information’ section.
5.3.8 Each contribution by a team member should be entered in the comments section. The date and time this was done is automatically populated by the system.
5.3.9 Once Change Request record is completed and all supporting documentation attached or referenced, the Project Leader/System Owner and QA should sign and date the ‘Post-Approvals’ of the change.
5.3.10 The Change Request Coordinator must ensure that all deliverables have been provided and the record has been completed correctly and approve the record. This is performed in the ‘Post-Approvals’ stage by completing the ‘Committee Post-Approval’ section.
5.4 Closing a Change Request
5.4.1 Post Approval for the Change Request is to be completed by the System Owner and the Change Request Coordinator on behalf of the committee.
5.4.2 A notification should be sent to Quality Assurance for final approval of the Change Request. Once final approval from Quality Assurance is completed, the Change Request can be sent to CR coordinator for closure.
5.4.3 The proposed action associated to the Change Request must be documented and completed.
5.5 Cancelling a Change Request
5.5.1 If at any stage during the life cycle of a change, it is determined that the change should no longer be implemented, the Change Request should be cancelled.
5.5.2 The Change Request Coordinator or Quality Assurance can only perform this closure.
5.5.3 The Project Leader should enter the justification for cancelling the Change Request in the comments section or attach the justification to the file attachments.
5.6 Like-for-Like Changes
5.6.1 Like-for-Like changes are defined as those changes where there is a direct replacement of a component with another that is exactly the same in all aspects including:
– Material of construction
– Dimensions
– Accuracy and Operational Specifications-Functionality
– Inputs and Outputs
Changes that comply with this definition need to be processed under the Change Management System, and they must be adequately documented and commissioned to provide traceability and history.