Modernization of USP Packaging Standards for Glass and Elastomeric Components
The modernization of USP (United States Pharmacopeia) packaging standards has been ongoing since 2015 1), 2). On June 19-20, 2017, USP conducted a workshop to discuss the modernization of its glass and elastomeric standards 3). During this workshop, USP Expert Committee members gave an overview, background and rationale for the proposed revision to the glass and elastomeric standard. There were also presentations on current U.S. Date Title Location September 10-12 RAPS (Regulatory Affairs Professional Society) Annual Conference Washington, D.C. September 11-12 PIC/S (Pharmaceutical Inspection Cooperation Scheme) Committee Taipei September 17-18 GCRSR/GSRS Brasilia September 19-21 12th IMDRF Management Committee Meeting Ottawa October 9-10 CoRE Advisory Board Meeting Singapore October 23-26 12th International Summit of Heads of Medicines Regulatory Agencies / International Coalition of Medicines Regulatory Authorities (ICMRA) Kyoto PMDA Updates August, 2017 Page 5 regulations related to pharmaceutical packaging and on analytical methods for determining packaging containers quality. Dr. Yukio Hiyama, a Japanese Pharmacopoeia (JP) Expert Committee member who works at the National Institute of Health Sciences (NIHS) attended the workshop, and gave a presentation on the packaging requirements in JP 17th Edition. During his presentation, he also outlined the pharmaceutical packaging chapter revisions in the first supplement to JP 17th Edition, including a new general information chapter for glass containers.
By attending this workshop, I was able to learn: ①the importance of the packaging system impacting on drug product quality and patient safety; ②majority of the particles that you find in a finished drug product comes from the packaging system and its assembly; ③ in the select of a packaging material/component one has to have a basic understanding of the component characteristics and the intended use of the component (e.g. oral product vs. injection) and: ④ the necessity to set the appropriate control specifications, based on information about the component and its manufacturing process.
The management of pharmaceutical packaging is important in order to assure product/packaging compatibility, quality and safety. Therefore, I will keep watching trends of technologies and regulations related to pharmaceutical packaging.
1) Comment Period Extended for Packaging General Chapters Appearing in Pharmacopeial Forum 43(3) http://www.uspnf.com/notices/comment-period-extended-packaging-general-chapters-appearingpharmacopeial-forum-43-3
2) General Chapters: <659> Packaging and Storage Requirements, <661> Plastic Packaging Systems and Their Materials of Construction, <661.1>Plastic Materials of Construction, <661.2> Plastic Packaging Systems for Pharmaceutical Use http://www.uspnf.com/notices/general-chapters-plastic
3) USP Workshop on Modernization of USP Packaging Standards for Glass and Elastomeric Components http://www.usp.org/meetings-courses/workshops/modernization-usp-packaging-standards-glass-andelastomeric-components
Dr. Yujiro Kameyama
PMDA’s Liaison Officer stationed at USP in the U.S.A
Modernization of USP Packaging Standards for Glass and Elastomeric Components
The modernization of USP (United States Pharmacopeia) packaging standards has been ongoing since 2015 1), 2). On June 19-20, 2017, USP conducted a workshop to discuss the modernization of its glass and elastomeric standards 3). During this workshop, USP Expert Committee members gave an overview, background and rationale for the proposed revision to the glass and elastomeric standard. There were also presentations on current U.S. Date Title Location September 10-12 RAPS (Regulatory Affairs Professional Society) Annual Conference Washington, D.C. September 11-12 PIC/S (Pharmaceutical Inspection Cooperation Scheme) Committee Taipei September 17-18 GCRSR/GSRS Brasilia September 19-21 12th IMDRF Management Committee Meeting Ottawa October 9-10 CoRE Advisory Board Meeting Singapore October 23-26 12th International Summit of Heads of Medicines Regulatory Agencies / International Coalition of Medicines Regulatory Authorities (ICMRA) Kyoto PMDA Updates August, 2017 Page 5 regulations related to pharmaceutical packaging and on analytical methods for determining packaging containers quality. Dr. Yukio Hiyama, a Japanese Pharmacopoeia (JP) Expert Committee member who works at the National Institute of Health Sciences (NIHS) attended the workshop, and gave a presentation on the packaging requirements in JP 17th Edition. During his presentation, he also outlined the pharmaceutical packaging chapter revisions in the first supplement to JP 17th Edition, including a new general information chapter for glass containers.
By attending this workshop, I was able to learn: ①the importance of the packaging system impacting on drug product quality and patient safety; ②majority of the particles that you find in a finished drug product comes from the packaging system and its assembly; ③ in the select of a packaging material/component one has to have a basic understanding of the component characteristics and the intended use of the component (e.g. oral product vs. injection) and: ④ the necessity to set the appropriate control specifications, based on information about the component and its manufacturing process.
The management of pharmaceutical packaging is important in order to assure product/packaging compatibility, quality and safety. Therefore, I will keep watching trends of technologies and regulations related to pharmaceutical packaging.
1) Comment Period Extended for Packaging General Chapters Appearing in Pharmacopeial Forum 43(3) http://www.uspnf.com/notices/comment-period-extended-packaging-general-chapters-appearingpharmacopeial-forum-43-3
2) General Chapters: <659> Packaging and Storage Requirements, <661> Plastic Packaging Systems and Their Materials of Construction, <661.1>Plastic Materials of Construction, <661.2> Plastic Packaging Systems for Pharmaceutical Use http://www.uspnf.com/notices/general-chapters-plastic
3) USP Workshop on Modernization of USP Packaging Standards for Glass and Elastomeric Components http://www.usp.org/meetings-courses/workshops/modernization-usp-packaging-standards-glass-andelastomeric-components
Dr. Yujiro Kameyama
PMDA’s Liaison Officer stationed at USP in the U.S.A