4 Steps to Effective Change Control in Pharmaceuticals : Pharmaguideline

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4 Steps to Effective Change Control in Pharmaceuticals

There are a number of steps that must be taken in order to successfully implement change in a pharmaceutical company.
The pharmaceutical industry is the most impactful industry for human beings because it has direct impact on people’s lives. But the pharmaceutical industry is also a business and the personnel working in pharmaceutical industry can make errors like any other industries. These human errors can lead to serious consequences for patients and workers. To prevent these problems from happening, a good change control system is required. In this article, we will understand 4 simple steps that will help you have an effective change control system.

1. Understand the Problem

The first and most important step of effective change control is to understand the problem found in the process or system. Change control helps to manage any change in the process or system. It ensures that changes made in the process are safe and beneficial for both the product and patients.

change control
For an effective change control, several steps need to be taken. The most important step is to identify the problem that is dome by identifying previous data. After the identification of problem, a plan is developed to address the problem effectively. This plan must include details like how and when changes will be made and what resources will be required.

After the development of the plan, it is very easy to implement because now you have implementation strategy. Implementation includes the training of employees, preparing the checkpoints throughout the process or creating plans to respond in an emergency. Finally, it is very important to monitor the changes and their impact on the process and system.

2. Create a Change Management Plan

There are various steps must be required to take to implement the change control effectively in pharmaceutical company. The most important step is to create a change management plan. The change management plan is an outline of the steps that will be taken to implement the changes. It ensures that the changes are done smoothly with any incident.

Training of employees on handling the change is another important step. This training should include everything from reporting any issue with changed process or system to how to communicate the change within the downline. There should be a system to track the progress and accountability. This will help to understand that the changes are successful and meet the goals for with changes are made.

Finally, there should be a plan to respond to any issue faced during the implementation of change. Sometimes there is employee resistance to any change but with a solid plan, these types of resistance can be avoided. In such situations, these plans are important to move the company forward towards its goal.
Related: Key Preposes of Change Control in Pharmaceuticals

A. How to Create a Proposal for an Effective Change Control

An effective plan for change control is the most significant move that the company can make to execute successful change management. Below are some tricks to create a proposal for change control.
1. Be clear about what you want to change and what change would you like to make happen. This step will help you to know that the change required or not and whether it will work without any change.

2. List all the risks and problems that could be caused due to change being made. It will help to understand you know the possible problems that could be caused because of the change.

3. Build a timeline which will include details of the way the change will be implemented. This will allow you to see the results of the introducing the changes as well as tracing along the deadlines you have set for the project.

4. Give consideration to main steps while putting the change into practice and make sure those are regularly monitored. It will show that the transition is going well and there has not been any other negative aspect for it to be seen.

5. List the benefit versus the cost associated with the recommended change. This will help in finding out that change is beneficial both in terms of cost effectiveness and manufacturing process.

B. How to Write an Effective Change Control Justification

Write an effective change control justification and it will help to communicate the change to the management and the stakeholders.

For an effective change control, you must take into account the following:
  • What are the possible dangers linked with recommended changes?
  • What are the advantages of carrying out those changes in a particular way?
  • How is the change anticipated to be implemented?
  • What would be the result if we don’t make this change?
  • Are there any adjustments that require to be made for this change to happen?
  • By when should these changes have been completed?
  • Who will implement this transformation process?
  • Who will monitor progress and record keeping?
  • In case of a negative effect from such a change, what need we do?
  • What are the impacts of the delay in completing the change?
Once you have answered these questions, you can plan for implementation of change and also track the progress to ensure the effective execution of change implementation within the time.

3. Implement Change

A. Implementation of Change

Implementation of change is a critical step in the pharmaceutical change management system. Change management is the process of planning and controlling the changes made in the process or systems in the pharmaceutical industry. It is essential to ensure that the changes are made in a controlled manner to continue the process smoothly.

B. Create Action Plan

Creating an action plan is also an important part of change management. This document outlines the steps to implement the change that is approved by the management. This includes the timeline and decision points required in way of implementation.

C. Communicate the Plans and Updates

After creation of action plan, you need to communicate it with the stockholders including employees, management and suppliers. Updates on the progress of the change control implementation should be mode to aware everyone about the progress.

D. Manage Resistance and Adaptation

During implementation of change it is an important task to manage the resistance and adaptation of employees. Sometimes it is challenging but it is important to ensure that all stakeholders are agree to follow the plan. Make the adjustment if required to satisfy the all stakeholders.

E. Celebrate the Success

When changes have been implemented successfully, it is important to celebrate the success. It not only provides a sense of completion for all involved but also shows the importance of change initiative.

4. Monitor and Evaluate the Success of Change

One of the most important steps of change control is monitoring and evaluation of the success of the change.it is done by tracking the progress of the process, measurement of the impact of change and determining the requirement of any further change to smooth line the process.

It is important to monitor and track the change process, make sure if there any requirement of any adjustment. This includes, how people are reacting to the change, progress of the work, any problem in the process due to change. If there is any problem due to change, it is required to react as quickly as possible to resolve it and streamline the process.

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of pharmaguideline.com, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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