Registration Drift is the term used to describe the process where a Product License (PL) or Marketing Authorisation (MA) begins to drift away from the actual methods, processes and controls used for the manufacture of the licensed product. This is a phenomenon which if left unchecked can result in serious patient safety issues.
This is referred to as conformance and is a legal requirement to ensure the plant and manufacturing documents continue to be aligned to the Product Licence or MA. This should not be confused with compliance, which refers to compliance with cGMP and ICH requirements and is typically managed and controlled by the Quality Assurance (QA) group.
Registration Drift, or Product Conformance may be easily diagnosed by answering some simple questions:
• Are your products more than 15 years old?
• Are your products manufactured by third parties under contract?
• Has your company been involved in Merger and Acquisition activities?
• Do you have high staff turnover and rely on “freelancers” and individual contractors to support your Regulatory Affairs department?
From our extensive experience in managing and resolving Registration Drift (in over 8000 MAs), we have identified that particular sections of Module 3 of the CTD are more prone to drift than others. 24 key sections having been highlighted as most susceptible to conformance discrepancies; more information on these specific sections are available by contacting us. To resolve Registration Drift a single, consistent Change Control process that spans the full manufacturing, testing and registration disciplines is critical.
How Woodley BioReg can help with Registration Drift
Woodley BioReg has developed a process for the identification and remediation of Registration Drift as a solution to Product Conformance issues:-
WBR is an expert in the field of conformance and continues to help clients identify and manage Registration Drift by developing tailored processes to ensure the future potential for drift is eliminated. Our consultants are specialists in the field of managing Registration Drift and regularly deliver presentations and papers on the topic. One such paper “Product Conformance and Registration Drift” was published in TOPRA’s Regulatory Rapporteur can be downloaded here. As part of our continued commitment to the industry and Regulatory Affairs, we are happy to offer a no-obligation initial diagnosis of your susceptibility to Registration Drift and potential courses of action to mitigate the risk and ensure Product Conformance.
For more information on Registration Drift and the 24 key sections identified as the most susceptible to conformance discrepancies, or to download our paper on “Product Conformance and Registration Drift” please contact us.