Key Preposes of Change Control in Pharmaceuticals

Change control is an important part of the pharmaceutical quality management system. It ensures that all changes are done in a controlled manner and changes made in the system do not have any adverse impact on the product quality. In this article, we will discuss the main purpose of the change control in pharmaceuticals.

1. Regulatory Compliance

There are various guidelines set up by different national and international regulatory agencies like USFDA, EMA, WHO, ISO and other regulatory bodies. Companies must comply with these regulatory guidelines for change control implementation.

2. Risk Management

Any change in the system or any process may cause an adverse effect on the quality of the product. Proper implementation of change control can mitigate the potential risks that may arise due to the proposed change.

3. Documentation and Accountability

Change control has documentation of all changes in the system or any process thus all changes are documented properly in the change control system. These changes can be assessed anytime as per requirement by the regulatory authorities at the time of audits and that shows the accountability in the organization.

4. Ensuring Product Quality and Safety

Change control helps to ensure the quality and safety of the product. Any change in the pharmaceutical process can impact the quality of the product. Even a very small change can have a significant impact on the quality of the product. A properly executed change control can help to identify the risks associated with change and the changes can be evaluated before they are implemented in the system.

5. Continual Improvement

Change control not only helps to manage the risks associated with changes made in the system but also helps to improve the pharmaceutical processes. When proposed changes are analyzed carefully, they not only help in enhancing the efficiency but also help to reduce the cost of the product by making the system streamlined. Due to change control implementation, systems and procedures are continuously improved day by day.

6. Minimizing Unintended Consequences

When changes made in any system are unplanned they can lead to unwanted consequences. These consequences may adversely affect the quality of the product. A properly implemented change control system can help to check these consequences and help to identify the issues before they become big problems.

Any change made in the system or process must be documented and it should be addressed through the change control system. Risks associated with the change must be identified and addressed before the implementation of the change. Most of the regulatory agencies look for change control systems during the regulatory audits.

Get documents for Audit preparation in MS-Word FormatView List

Share

Tweet

Share

Pin it

Share