PT  - JOURNAL ARTICLE
AU  - Osamu Shirokizawa
AU  - Keisuke Inoue
AU  - Tsutomu Kamikukita
TI  - Overview of "The Study in Risk-based Manufacturing Environmental Control for Non-sterile Drug Products"
AID  - 10.5731/pdajpst.2018.009308
DP  - 2021 Jan 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - pdajpst.2018.009308
4099  - http://journal.pda.org/content/early/2021/05/14/pdajpst.2018.009308.short
4100  - http://journal.pda.org/content/early/2021/05/14/pdajpst.2018.009308.full
AB  - To develop a guide of best practices for establishing appropriate controls on nonsterile manufacturing environments for pharmaceutical manufacturers, the Kansai Study Group of the Parenteral Drug Association Japan Chapter explored relevant issues in-depth and published the results of their study, ″Manufacturing Environmental Control for Non-sterile Drug Products″ in the PDA Journal of GMP and Validation in Japan (1). This review summarizes the background of that study and the structure of the published article and, to help readers make the most of the contents, provides a table displaying the category, subject, Problem Statement, and points to consider of each topic discussed in the article, as well as examples of central topics (Appendices 1-3).