| Autor: |
Yamada, Masahiro, Badr, Sara, Fukuda, Shouko, Nakaya, Manabu, Yoshioka, Yasuyuki, Sugiyama, Hirokazu |
| Zdroj: |
Journal of Pharmaceutical Innovation; Mar2021, Vol. 16 Issue 1, p38-52, 15p |
| Abstrakt: |
Purpose: Choosing the optimal lot size in drug manufacturing has critical implications for process scheduling and economic performance. There are no rigorous models addressing drug product manufacturing. This work offers a lot-sizing model to avoid empirical decisions for lot resizing at various drug lifecycle phases or for grassroot design of injectable drug product manufacturing. Methods: An economic lot-sizing model for manufacturing injectables that included process-specific risks and aspects such as rates of defective products, quality control, and changeover operations was developed. Change-control costs for revalidation required by regulatory authorities in case of lot resizing were also considered. A sensitivity analysis was carried out to determine influential model parameters. Results: Two case studies representing different drug profiles demonstrated the use of the method: (i) an inexpensive injectable filled in an ampule after patent expiry; (ii) a new, expensive injectable product filled in vials. Depending on the drug profile, the controlling factors were found to be different, e.g., overtime production scheduling in case (i) and defective product rates in case (ii). Conclusion: This work highlighted the usefulness of model-based approaches for determining influential parameters, design tradeoffs, and improvement potential. The approach was demonstrated for retrofit and grassroot design cases in pharmaceutical manufacturing. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
|
Full text from SpringerLink