Woodley BioReg has coined the term “registration drift” to describe the process where a Product Licence (PL) or Marketing Authorisation (MA) begins to drift away from the licensed details for the methods, processes, and controls used for the manufacture of an approved product. This is a phenomenon which if left unchecked can result in serious patient safety impacts.
Registration drift addresses product conformance and maintenance; there is a legal requirement to ensure the PL/MA continues to be aligned to the actual manufacturing details. This activity is typically undertaken by regulatory affairs.
Whilst being equally important, assurance of product compliance refers to compliance with quality requirements including cGMP and ICH conditions and is typically managed and controlled by the quality assurance (QA) group.
How can they be diagnosed?
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 WBR’s extensive experience in managing and resolving registration drift in over 10,000 MAs globally, specific sections of m3 CTD dossiers that are prone to registration drift have been identified. There are 24 key sections having been highlighted as most susceptible to conformance discrepancies.
To resolve registration drift a single consistent change control process that spans the full manufacturing, testing, and registration disciplines is critical.
More information on the specific CTD sections and assessment and remediation are available by contacting us.
Need further information?
Woodley BioReg has developed a robust process for the identification and remediation of registration drift as a solution to product conformance issues:
The WBR team is 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 consistently 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.
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.