RT Journal Article
SR Electronic
T1 Overview of “The Study in Risk-Based Manufacturing Environmental Control for Non-Sterile Drug Products”
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 490
OP 505
DO 10.5731/pdajpst.2018.009308
VO 75
IS 6
A1 Osamu Shirokizawa
A1 Keisuke Inoue
A1 Tsutomu Kamikukita
YR 2021
UL http://journal.pda.org/content/75/6/490.abstract
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, “The Study in Risk-Based Manufacturing Environmental Control for Non-Sterile Drug Products” in the PDA Journal of GMP and Validation in Japan. 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).