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OOS Investigation Tools: A Comprehensive Guide

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Introduction In the pharmaceutical industry, Out-of-Specification (OOS) events can have significant consequences, impacting product quality, patient safety, and regulatory compliance. Effective OOS investigation is crucial to identify the root causes, implement corrective actions, and prevent future occurrences. This blog post will explore various tools and techniques employed in OOS investigations. Essential Tools for OOS Investigations Data Analysis Tools: Statistical Software: Leverage software like Minitab, Excel, or specialized statistical packages for data analysis, trend identification, outlier detection, and process variability assessment. Quality Management Systems (QMS): Utilize QMS software to centralize and manage quality data, facilitating efficient data retrieval, analysis, and reporting during investigations. Electronic Batch Records (EBR): Employ EBR systems to capture and store detailed manufacturing process information, aiding in tracing back steps, identifyi
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Change Control In Pharma

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Change Control  In Pharma

Being a pharmaceutical company, all the formulations must be accurate to have controlled manufacturing of effective dosage forms. However, due to Pharmacopeial updates and current regulatory requirements, changes may happen in the existing processes, documents, and process flow. Hence to cater and to document change history, the pharmaceutical company uses a change control management system.

Change control system is part of the quality management system. It is a very important tool of the pharmaceutical industry. It is the system that is used to track, record and control all changes occurring in the pharmaceutical industry. This system is utilized to address the changes being effected in the existing processes, practices, formulations, standards, and documentation.

As we know there are many departments in the pharmaceutical industry but all are interlinked with each other. So, everyone has to know every change.

What is change control?

Definition of change control:

Change control is a systematic approach to managing all changes made to a product or system. The purpose is to ensure that no unnecessary changes are made, and all changes are documented. 

Need of change control system:

  • To track changes
  • To make a record of change
  • To make it know everyone about the change
  • To identify the impact of change in the existing system

When to take change control?

  • To revise documents (SOP, Protocols, BMR, BPR, specification, change in the facility, change in equipment, relocation, etc.)
  • To create new documents (new documents like SOP, Protocol, Vendor document, Qualification documents, specification, procedure, BMR, BPR, site master file, Validation master plan, assessment, etc.)
  • For procurement of new equipment’s, for new facility up-gradation
  • For civil work in the existing facility.
  • To implement a new procedure or process or any change in procedure
  • For new product introduction
  • For the implementation of a new vendor/ supplier/ external service provider

Types of change control

  • Major
  • Minor
  • Critical

Change Control Management Procedure:

Change Control
Change Control Procedure In Pharma

1. Change Initiation In Change Control System:

The first step is to identify the need for change control as given in the above points. Make a request for change control to the quality assurance coordinator mentioning the reason for the change. A person who gave a request for change control will be the change control owner/ initiator. The quality Assurance coordinator will issue the change control with a specific number name and reason for the change. change control owner will Fill up the change control form. Existing and proposed changes with the reason for changes to be mentioned in the form by change initiator

2. Change Evaluation In Change Control System:

The Head of the department along with the cross-functional team members will review and acknowledge the change request and will categorize it into minor, major or critical changes. The quality assurance coordinator will review the changes and reason for changes and will give clearance for acceptance or rejections for change control.

3. Impact Assessment of Change In Change Control System:

With discussion with all stakeholders, change control initiator and all cross-functional team members will identify the impact of change on existing process, document, specification, SOP, limits, equipment, layouts, site master file, training, schedules, product, validation requirement, and their respective department.

4. Enlisting of activities (Action Plan) In Change Control System:

The change initiator will prepare the action plan of actions to be implemented. All cross-functional teams will review the action plan and if required will add the activities which are impacted. This action plan approval will be done along with the main change control document. Timelines shall be given for the implementation of activities. If the timelines are not met there should be a procedure to provide extensions to timelines. It also required quality head approval.

5. Approval of Change Control:

After review and comments, change control shall be in the cross-functional team members' approval phase. Other departments will accept the change and the quality assurance head will approve the change. Only the quality head will have the writes of approval and/or rejection of the change. If the change is major or critical, the change control shall be submitted for corporate quality assurance, regulatory affairs department, and marketing authorization (If 3rd party is available). After acceptance by Quality The assurance coordinator and identified stakeholders' quality head will approve the change.

6. Change Implementation In Change Control System:

If all stakeholders agreed to change and give approval for change control then the Site head and Quality Assurance head will give approval for implementing change control. After approval, all the activities can be implemented. After implementation, as evidence, the respective documents need to attach to the action plan.

7. Closure of Enlisted Activities In Change Control System:

Finally, after change implementation, the action plan can be closed. The actions which required post-implementation review will undergo the same. Change control owner and Coordinator will track all activities and will document them.

8. Change Control Closure:

After completion of all activities identified in change control, the head of the department will give comments for closer of change control, and then stakeholders will give comments for closure of change control. If all activities are completed then change control can be closed. The quality Assurance coordinator will check all change control for completion for all predefined listed activities, impacted documents, and attached metadata for change control. After review of Quality Assurance coordinator plant head and Quality Assurance head will give comments for closure of change control. After comments by the Quality head will identify a need for post-implementation checks for change implemented.

9. At last change control will close.

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