Change control programs are essential elements of pharmaceutical quality assurance systems, vital for the continued manufacture and operation in the pharmaceutical industry, but what exactly are they? Read more about this topic below.
In practice, a significant change in your operations is any change that may impact the quality, safety, traceability, or decision to register the products marketed. These changes may relate to:
• Manufacturing, monitoring, or quality control processes.
• Processes covered by the quality system.
• Facilities, equipment, or utilities,
• Raw materials and packaging items or any other component of the product.
• Supplier and outsourced activities.
• Computerized system.
For these situations, the EU GMP Guidelines (Eudralex vol 4) defines “Change Control” as “a formal system by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect the validated status of facilities, systems, equipment, or processes”, adding that “the intent is to determine the need for action to ensure and document that the system is maintained in a validated state”. This is relevant to you, as a pharmaceutical manufacturer, because you need to have processes in place that guarantee your product remains validated by the relevant authorities.
To this extent, your own change management should involve all the relevant departments for successful change implementation, by following the regulatory requirements. Change management is, therefore, applicable for all processes and products covered by the Quality system, and this should allow for the implementation of the continuous improvement process and the maintenance of compliance with normative and regulatory requirements.
Ultimately, this will help you avoid any sanctions by the authorities, as far as Change Control, with an elaborate and concrete SOP, addresses all possible scenarios, making it possible to ensure correct work. RC REDOL can be your partner in this journey, providing the experience and necessary know-how for your organization to keep up to date with the regulations and to ensure correct quality management. Don’t allow your organization to fail where it could have succeeded, by contacting us today!
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