…during the planning, manufacturing, testing, reviewing, releasing and storage of a batch…
It starts with a clear vision of right-the-first-time manufacturing and understanding the critical attributes. Delivering high-quality products happens:
…by putting compliance-ready processes in place from research through commercial manufacturing, within the supply chain process, as well as on the shop floor and in the labs.
Many technologies can help play a role as compliance enablers, such as:
…data integrity, data analytics, continued process verification, PAT, electronic batch records, electronic log books and predictive analytics…
We’ve discussed many of these enabling technologies in earlier Life Sciences-related posts here on the blog.
By viewing the manufacturing process from research & development all the way up through commercial-scale manufacturing, some of the compliance enablers include:
…build process understanding, design capable processes, and deliver appropriate controls. Design of experiments and PAT are also important pieces of this process.
Tools for process control, data collection and recipe management are honed and transferred through the lifecycle.
Michalle highlights other dimensions in building quality and compliance into the manufacturing process. These include fault detection and predictive diagnostics, manufacturing business processes, and accurate & reliable measurements & on-line analysis.
Read the article for more on these tools and the role of organizational culture, as well as the importance of sharing these tools & processes with other suppliers across the supply chain.
You can also connect and interact with other pharmaceutical and biotech industry experts in the Life Sciences group in the Emerson Exchange 365 community.