“Our goal is to determine if the firm’s manufacturing operations are in a state of control. The CGMPs are a management-based regulatory approach. We do not specify how a company must structure its quality system. The regulations provide general expectations and we let the firm’s management structure its GMP compliance program accordingly. A GMP inspection will then be conducted to determine the effectiveness of a firm’s quality system. There are many ways to make this assessment; however, there are some key areas that investigators are trained to focus on.”
Senior regulatory operations officer at the Office of Compliance of the FDA’s Center for Drug Evaluation and Research (CDER).
Operating in regulated environments, Pharmaceutical and Medical Device companies are expected to establish and follow procedures for effective change control in order to ensure product quality. As a Quality professional, you will be responsible for ensuring that changes with the potential to impact product quality are recorded, assessed and tracked. This already challenging task can be made more difficult if you are using a paper-based or a hybrid (mix of of paper and computer) system. A typical manufacturing environment will see you having to manage a multitude of changes and often at the same time. Some examples of changes that need change control include:
Timelines are essential in change control systems. A paper-based/hybrid system that relies on physical documents to record data and old-fashioned legwork to co-ordinate approvals and track activities takes a considerable amount of time to manage. In addition, such a system will make it harder for you to follow-up tasks and ensure they are completed by due dates.
Typically, organisations that use paper-based/hybrid systems for change management operate with little or no connectivity between Quality functions/workflows. Working in such an environment, your employees will struggle to keep up with all the changes and expose your business to GMP non-compliance issues. For example, changing a process also requires changing the relevant documents and then training personnel on the new versions. If these quality system elements (change control, document control and training) are not connected, how can you be sure everything has been done?
To address these issues, more than 1,000 Pharmaceutical and Medical Device companies around the world use MasterControl's Management of Change system, including the US FDA. The Change Control solution helps ensure that your manufacturing operations are in a state of control, complying with the requirements of regulators such as the US FDA, MHRA, TGA, HSA and Medsafe.
SeerPharma is a strategic partner of MasterControl and has deployed this solution for many companies in the Asia-Pacific region.
For more information on how this solution could work for you, please visit: https://www.seerpharma.com/services/qms-software/mastercontrol/change-control
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