Successfully Managed Alternative Drug Substance Approval for Business Continuity: Case Study Overview
The pharmaceutical sector is expected to adhere to constantly changing regulatory standards throughout the life cycle of a medical product. Companies strive to maintain their market authorization while ensuring the quality and safety of their products. Thus, understanding the subtleties of post-approval life-cycle management is crucial. Ensuring business continuity requires post-approval modifications, driven by enhancing processes, lowering raw material costs, and addressing market issues.
Staying abreast of the current regulatory requirements incurs an enormous cost. Employing qualified regulatory specialists reduces costs for the industry, particularly when managing a large product portfolio across several regions.
A change in the drug substance during the post-approval period may occur due to several factors, including issues related to the quality, cost, or supply chain of the drug substance. To ensure that the drug product satisfies its intended quality, safety, and efficacy levels, regulatory bodies worldwide have specified the requirements and conditions that must be met.
Managing Alternative Drug Substance Approval: Case Study Highlights
A leading pharmaceutical company sought assistance with a post-approval change for the introduction of an alternative source of the drug substance for one of their products. Their specific challenges included:
- Vast drug and device portfolio
- Small team with limited regulatory experience
- Involvement of multiple contract manufacturing and testing organizations
- Risk associated with drug substance supplies from the existing supplier
A comprehensive package for the introduction of an alternative source of the drug substance with quality data from the alternative vendor was created with the help of the client and the efforts of APCER’s Regulatory Affairs team.
The supplement was promptly submitted to the US FDA, ensuring compliance with the latest regulatory standards.
The US FDA authorized the CBE-30 supplement without any questions and within the specified time frame. Thus, the risk of drug substance supply issues and in turn business continuity was addressed.
How can APCER’s Regulatory Affairs Team Help with Drug Substance Approval Management?
APCER’s team handled the case through a structured process involving:
- Evaluation of change control for quality documentation
- Assessment of quality data on the approved dossier
- Application of the current regulatory knowhow while categorizing the change
- Frequent and constructive communication with the client and their partners, thereby ensuring the completeness of the data generated
- Compilation, publishing, and submission of the supplement to the US FDA