Get To Know Change Control In The Pharmaceutical Industry

Change control is a method and system in the pharmaceutical industry to control change so that it does not run wild so that it does not have a bad impact on the company.

Definition of Change

Change is a phenomenon that cannot be avoided, especially in the pharmaceutical industry along with various advances in technology and knowledge, machines and manufacturing processes that tend to change over a certain period of time. These changes have the main objective, namely as an effort to increase efficiency in drug production. The change in question is always a change that leads to positive things. A change must coexist with a control measure so that the change is controlled during the process. These changes need to be controlled so that they can get out of hand and harm the company.

An official change control treatment always begins along with a change proposal, which is triggered by user department staffs along with proper reason. The change plan after that, assessed by a specialist crew (change control board) providing the suitable knowledge and expertise coming from relevant regions.

In the pharmaceutical industry, the term change and deviation control is known. Both have differences, namely:

Change Control is a strategic activity to make changes to documentation or processes or methods. It can be for a smaller period of time or can be used for a longer term, and must be notified to all relevant departments for official change control approval.

Deviation is a deviation from a certain procedure that was performed previously or accidentally. The deviation can be divided into critical & non critical. The effects of deviations should be accessed through a CAPA investigation.

Types of change

Changes are divided into 2 levels, namely major changes and minor changes. Major changes are changes that affect product quality or quality or process reliability, while minor changes are changes that have no effect on product quality or quality. Examples of major changes are changes in the production process, changes in product composition, changes in process parameters and others. While minor changes are replacement of tool parts in the same design, change of cleaning agent for floors, change of laundry place.

Principles of Change Control

Change Control according to GMP 2018 case 430 is a formal system that is used to assess a proposed change or changes that may affect the validation status of the facility, systems, equipment or processes. Its purpose is to establish actions that will ensure and document that the system is maintained in a validated state to improve product quality and safety.

Change Control is an important part of the quality management system in the pharmaceutical industry. Inadequate change control procedures will create a risk and violation of several quality system regulations so that all change control procedures must be carried out in accordance with approved policies. In the Change Control procedure, there must be a written procedure that contains steps to be taken if there is a proposed change to the starting material, product components, equipment, processes, building-facilities, product range, production process or testing method, batch size, design space, or any changes to the product life cycle that may affect quality or reproducibility.

In addition, changes made must be evaluated through Quality Risk Management (MRM) to determine potential impacts on product quality, pharmaceutical industry quality systems, documentation, validation, compliance with applicable requirements, calibration, maintenance and other systems to avoid unintended consequences. desired and to plan the necessary validation, verification efforts. Changes made must also be approved by the Quality Assurance department in the pharmaceutical industry. It was concluded that this change control includes several activities, namely submitting changes, evaluating changes, approving changes.