Modern drug manufacturing operations of parenteral medicines are driving the need to monitor each process with greater precision and visibility. This evolution is also driving health authorities and regulators to look for much higher levels of traceability during each process to drive a step change in quality.
Unique containers are starting to improve the production quality and efficiency by providing container level insight into each process. This data is helping to reduce risk, drive more detailed root cause analysis and improvements in both product and process optimization.
They can provide transparency and traceability at single object level, this can supplement traditional control strategies by allowing data-based decisions with the aim of reducing risk, accelerating drug delivery, and improving patient safety.
The ISPE have established a working group under the umbrella of the SCOPE CoP which is working with fifty-seven (57) stakeholders across the industry to create a Guidance Document covering all the key steps in the process.
This presentation will explain the concept of container traceability, the key operational benefits, the creation of standardized approach for unique containers and how this is being implemented in filling operations and machinery equipment.
The business case for the use of unique containers.
A standardisation of approach for the use of unique containers within the manufacturing operations.
Possible applications for existing and new machinery equipment.