Simon Chalk is director of the BioPhorum Operations Group, email@example.com
The biopharmaceutical industry is developing a new approach to controlling variability in raw materials.
For single-use systems, supply chain excellence requires a commitment to problem solving across organization boundaries.
Using closed systems opens up many new possibilities for how facilities are designed and operated and may also present lower risk to the operation and, ultimately, the product.
Maintaining flexibility in biopharmaceutical manufacturing can deliver positive results.
Additional challenges to the new cleanroom paradigm from concurrent multiproduct manufacturing of bulk drug substances in a controlled non-classified (CNC) ballroom environment.
Benchmarking can be a useful tool to improve manufacturing practices.
Improvement strategy should be linked to business strategy.
Is process-centered organization in biopharmaceutical manufacturing a stepping stone or a stumbling block?
A one-day sign off for batch records is considered a best practice in the industry.