BRIEFING
〈665〉 Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products, PF 43(3) [May–June 2017] and PF 45(2) [Mar.–Apr. 2019]. The General Chapters—Packaging and Distribution Expert Committee is proposing a new chapter to address the characterization of plastic components and systems used to manufacture biopharmaceutical drug substances and biopharmaceutical and pharmaceutical drug products.
A previous proposal for this chapter was published as Polymeric Components and Systems Used in the Manufacturing of Pharmaceutical and Biopharmaceutical Drug Products 〈665〉 in PF 43(3). A revised proposal was published as Plastic Materials, Components, and Systems Used in the Manufacturing of Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products in PF 45(2). On the basis of comments received, both proposals were canceled and are being replaced by the current proposal with the following significant changes:
Clarify the scope with respect to components, drug substances, and drug products.
Decouple this chapter from Plastic Materials of Construction〈661.1〉 and focus the current proposal on manufacturing components.
Clarify the component qualification versus selection as the chapter's focus.
Delineate the hierarchical relationship between component and materials testing.
Provide for flexibility regarding the design of the risk evaluation matrix.
Revise the risk-based chemical and biological reactivity testing requirements for components.
As currently proposed, this chapter does not state requirements that would be mandatory for compendial compliance purposes. Per General Notices 3.10, Applicability of Standards, a chapter below 〈1000〉 does not become an applicable general chapter unless referenced as such in General Notices, a monograph, or another applicable general chapter numbered below 〈1000〉. USP seeks input from stakeholders regarding the advisability of making 〈665〉 an applicable general chapter, and if so, the appropriate vehicle for doing so. The committee will work to finalize the content of the chapter. However, the chapter will not be an applicable general chapter unless and until it is referenced through one of the mechanisms stated in General Notices 3.10, Applicability of Standards.
To facilitate the use and support the understanding of this new general chapter, a new informational chapter, Characterization of Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products 〈1665〉, has been proposed and also appears in this issue of PF.
A workshop, USP Workshop on the Revision of Chapters 〈665〉/〈1665〉 Plastic Materials, Components, and Systems Used in the Manufacturing of Pharmaceutical and Biopharmaceutical Drug Products, took place on April 16, 2019, at the USP Meetings Center in Rockville, Maryland, to discuss these general chapters and comments were incorporated.
Source from USP and Please refer to USP for details:
plastic pharmaceutical packaging
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