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.