Almost four years in the making, the final guidance document from the PDA Japan Chapter is well worth the wait. Environmental Control and Maintenance in the Manufacturing of Non-Sterile Drug Products: Kansai Study Group (KSG) of the PDA Japan Chapter was added to the PDA Bookstore on 24 June, the culmination of a journey that began in July 2017.
My first introduction to the topic came from former PDA VP for Scientific and Regulatory Affairs and current PDA JPST Editor Richard Levy, PhD, when he asked me to work with Keisuke Inoue, Takeda, and Osamu Shirokizawa, Lifescientia, to prepare an article for the Journal reviewing the 90-page document and its background. A series of back-and-forth emails ensued, as I stumbled through the linguistics involved in understanding the different meanings of technical terms and concepts in the Japanese English version of the article. One instance really caught me up short when I saw the diagram for the entrance and exit paths of the dressing and undressing rooms.
In the process, I learned that in many Japanese pharma manufacturing facilities, the technicians are provided with uniforms to wear, rather than coverings over their street clothes; hence, the separate dressing/undressing rooms for men and women. I discovered more about the development of the guidance document that formed the basis for the Journal article when I viewed the poster Inoue and Shirokizawa presented at the “12th Annual PDA Global Conference on Pharmaceutical Microbiology” in October 2017. Their exhibition was very enlightening and meeting the gentlemen from Japan in person was a real treat. Finally, the faces behind the emails!
The opportunity proved valuable to Inoue and Shirokizawa as well; in addition to attending the conference, they toured the then-new TRI training center. Shirokizawa wrote: “We received a lot of visitors to our poster throughout the sessions. We had insightful discussion with them. We saw PDA has been providing a variety of training to learn about many key features of aseptic processing. We know how effective and important hands-on training is to any trainee.”
The sojourn through the manuscript submission process, needless to say, was a lengthy one. We tapped into the PDA membership to find reviewers knowledgeable about the subject. The first round of reviewers commented that it was difficult to make a decision about a paper based on a document they couldn’t see. While the full guidance document had been translated to English, the initial version needed additional editing to convert some of the terms to their American English equivalents. And I became a translator.
Over the years of sending sections of my “translations” for the JPDA team to accept, reject or amend, we began a respectful business friendship: Shirokizawa and Inoue became the more informal Osamu-san and Keisuke-san. We learned a little about one another’s lives, cultures and perspectives. Osamu volunteered to work on the TR 29 revision team and experienced the global collaborative effort of developing technical reports. He was later voted to join the PDA Board of Directors.
Osamu served as the primary contact between the PDA Publishing Group and the KSG, who provided feedback on all of the translated sections. I was humbled by the experience of knowing so many top business leaders took the time to read my many, sometimes minute, comments and changes in their valuable document. They truly valued the opportunity to share all they had learned through the original survey they conducted of pharmaceutical manufacturers in Japan and the best practices they had developed as a result.
In October 2019, Osamu stopped over on a business trip to meet again with Walter Morris, PDA Sr. Director, Publishing & Press Relations, and me at PDA’s Bethesda office. We spent some time going over the plans and timelines for converting the chapters of the guidance document and checking on the progress of the Journal article. It was a great opportunity to juggle what we said and how they understood it and vice versa. (This was when I learned about the dressing rooms.)
The time between now and then comprised numerous rounds of editing, commenting, revising, proofreading, and correcting on both sides of the world and the strings of emails that bridged the globe. A global pandemic interrupted the process and slowed down everything it didn’t stop immediately. And, at last, this production led to the final typesetting and publishing of, in my humble and completely unbiased opinion, both masterpieces.
To make a long story short, the final JPDA article, "Overview of ‘The Study in Risk-based Manufacturing Environmental Control for Non-sterile Drug Products’" by Osamu Shirokizawa, Keisuke Inoue and Tsutomu Kamikukita, was published as an Accepted Article on the PDA JPST website on 14 May 2021. And the English translation of the Environmental Control and Maintenance in the Manufacturing of Non-Sterile Drug Products: Kansai Study Group (KSG) of the PDA Japan Chapter was made available in the PDA Bookstore on 24 Jun 2021.
I hope sometime to visit our associates in Japan to see what else I can learn of their culture. In the meantime, pick up a copy of their guidance for yourself or your company. I am sure you will find some valuable and practical advice!
[Editor's Note: This article first appeared in the PDA Letter Asia-Pacific Edition, July 2021.]