Abstract
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).
Footnotes
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- Appendix 1: Category I, Topic B.1 Filter–-1: Selecting the appropriate air filter
- Appendix 2: Category III, Topic A.2 Gowning Rooms—–2: Separate entrance and exit routes
- Appendix 3: Category V, Topic A.1 Standards of Cleanliness: Setting standards of cleanliness based on airborne particulates
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