Manufacturing is not the only department affected by regulatory compliance issues. In addition to these issues having an impact on good manufacturing practices (GMP), regulatory bodies set ever-stricter standards for quality and documentation.
To retain certification, life science companies need to organize daily sample checks and be prepared at all times for unannounced visits by the regulatory authorities. OMP for Life Sciences enables cross-divisional collaboration on quality and compliance issues to give decision-makers the tools to manage these important issues.
OMP for Life Sciences treats handled regulatory issues as an additional planning constraint, taking into account which in-house or contract manufacturing organization facilities are authorized to produce a particular drug substance for specific customer segments and regions, and in the specified time frame.
This makes it easier to adapt and optimize your planning in response to new approvals (or disqualifications) following inspections by regulatory authorities. It also offers the ideal collaboration platform for S&OP and regulatory compliance teams to share input and co-develop alternative scenarios in response to expected (or delayed) approval dates. From the strategic to the operational level, it takes into account the available production capacity at every node in your supply chain ecosystem.
To boost collaboration between production, and quality assurance and control, OMP for Life Sciences empowers planners and schedulers to take into account throughput times for quality controls. This makes it possible to attribute priorities to urgent batches and get them tested first, to meet critical deadlines, or to prioritize key customers.
OMP for Life Sciences breaks down the wall between clinical and commercial products to achieve optimal trade-offs and smooth the research and product launch process. You can, for example, more easily anticipate patent approval to plan commercial production and distribution networks well in advance.
The collaborative portal offers intuitive visualization of both clinical and commercial capacity planning. You can orchestrate both at once, even when clinical and commercial production use the same equipment product lines, or reactors, or where products have been commercially approved for selected indications or patient groups, but may still be at an earlier clinical trial phase for others.
Stef Vermeiren, Vice President Global Planning – Janssen Pharmaceutica at Johnson & Johnson
Nathalie Loicq, Vice President Global Supply Chain at UCB
Steffen Heinecke, Project Lead for Global Supply Chain at Roche