USP Proposals Related to Packaging: A Call for Industry Response
Pending changes to the packaging requirements in the USP may affect pharmaceutical manufacturers. Results from a pulse-style survey of eleven U.S. pharmaceutical packaging professionals show that industry’s participation in the USP revision process is limited and in need of improvement.
A large proportion of the packaging materials used for pharmaceutical products in the United States follow the requirements described in the United States Pharmacopeiaâ€ˆ(USP). Container closure systems for pharmaceuticals are generally expected to meet the requirements of USP general chapters, either through citation in product registrations or direct references stated in the General Chapters, such as <1> Injections—Packaging and <661> Containers—Plastics.1,2 Because the USP is recognized in the Federal Food, Drug, and Cosmetic Act as an “official compendium,” its standards for packaging materials may be legally enforced by FDA.
Several critical changes have been proposed in USP General Chapters for packaging in recent years. These changes impact pharmaceutical manufacturers and their packaging suppliers. Therefore, it is essential that pharmaceutical manufacturers and suppliers participate in relevant proposals to ensure that technically sound standards are in place for pharmaceutical packaging. USP follows revision processes that provide for public input. For this process to work, however, manufacturers must be aware of the changes, make the effort to assess their impact, and communicate any concerns or counterproposals to USP. USP depends on industry to formulate appropriate public standards.
|See Sidebar: USP General Information and USP Structure|
The results of a recent survey of pharmaceutical packaging professionals suggested that industry awareness and participation has been limited. However, such participation is needed to ensure that appropriate, relevant standards for packaging are established. (Pertinent information about packaging and related standards in the USP1 is provided in the sidebars to this article.)
More than half of the survey respondents indicated a lack of awareness of specific packaging-related publications in the Pharmacopeial Forum (PF) over the past year. Although the responses acknowledged the importance of PF proposals to packaging, the responses also indicated a variable range of awareness of PF proposals and very limited participation in the USP process for commenting on recent PF proposals and articles related to packaging. Although the survey results are not provided, the topics that were covered in the survey are described in this article.
The overall importance of the following publications related to packaging was gauged:
- USP—National Formulary (NF) General Chapters.
- Pharmacopeial Forum Proposals.
- Pharmacopeial Forum Stimuli Articles.
Also considered was the frequency of reviewing the PF and responding to PF proposals related to packaging, such as proposals to add or change information.
Awareness of the following proposals in the recent PF was considered:
- PF 32(4)(July/August 2006)
<671> Containers—Performance Testing
- PF 32(4)(July/August 2006)
Stimuli Article: Proposed Revisions to USP Standards for Containers— Glass
- PF 32(4)(March/April 2006)
Stimuli Article: The Role of Container-Closure Systems in Stability Testing for Climate Zone IV
- PF 32(4)(July/August 2006)3 contained several proposals that in-volved the General Chapters for containers (<661> Containers and <671> Containers—Permeation). These were issued for public
comment in July 2006, with
comments due October 16, 2006. Examples of the changes are as
- The name of <671>
Containers—Permeation was changed to Containers—
- Additional performance tests were added to <671> Containers—Performance Testing. The Light Transmission Test, previously included in <661> Containers, was moved to <671>.
- A new General Chapter <660> Containers—Glass included sections that were previously included in
- A new glass test was added to <660> Containers—Glass in an effort to achieve alignment with The European Pharmacopoeia (EP) 3.2.1 Glass Containers for Pharmaceutical Use.
- The name of <671>
The proposals to add or change General Chapters <660> Containers— Glass, <661> Containers—Plastics, and <671> Containers—Performance Testing were published in final form in the second supplement (S2) to USP 30.2 There were a number of clarifications, but much of the content in the PF proposals was unchanged in the final publications in S2. However, a new test and requirement for multiple-unit containers under conditions of use (e.g., inner-seal removed) appeared in <671> Containers—Performance Testing in S2. These new and revised General Chapters will be effective six months after release on December 1.
|See Sidebar: USP Organization and Governance|
An example of another process that was used recently to gain industry comment involved the March 2007 PDA Conference in Las Vegas. In a PDA subcommittee meeting of about 40 members of the Packaging Science Interest Group (PSIG), the USP Parenteral Products–Industry Expert Committee (PPIEC) announced its intent to publish a final version of General Chapter <381> Elastomeric Closures for Injection. For several years, the PPIEC has attempted to align the physicochemical and functional tests in <381> Elastomeric Closures for Injection with the tests provided in the EP 3.2.9 Rubber Closures for Containers for Aqueous Parenteral Preparations, for Powders, and for Freeze-Dried Powders.
At the PSIG meeting, PPIEC member Dana Guazzo, PhD, reviewed a supporting study and provided an overview of planned updates since the <381> Elastomeric Closures for Injection proposal was last published in the January/February 2004 PF4. Edward Smith, PSIG chair, distributed the presentation to 283 PSIG participants with an offer by Guazzo for a 30-day comment period on the presentation from April 1 through April 30, 2007, to PSIG participants. On May 2, it was reported that six responses were received. A USP publication date has not been provided. Achieving alignment and elimination of duplicate testing of elastomeric closures by USP and EP methods is a hopeful outcome.
Active participation by industry in the PF review and comment process is important to ensure the most advanced and technically sound standards are in place for pharmaceutical packaging. Active participation is critical to ensure awareness of new standards as the USP implements a shortened publication and comment period timeline that is aligned with a strategy of continuous revision. For more information about the PF review and comment process, visit www.usp.org/USPNF/pf/?h.
1. USP 30/NF 25. The Official Compendia of Standards. Volumes 1, 2, and 3, The United States Pharmacopeial Convention Inc.
2. USP 30/NF 25. The Official Compendia of Standards. Supplement 2, The United States Pharmacopeial Convention Inc.
3. Pharmacopeial Forum 32 (4) [July/August 2006], pp. 1193-1197. P&S: D. Hunt, The United States Pharmacopeial Convention Inc.
4. Pharmacopeial Forum 30 (1) [January/February 2004], pp. 220-228. PPI: J. Kelly, The United States Pharmacopeial Convention Inc.
Dwain L. Sparks graduated from DePauw University in 1975 with a BA in Chemistry and completed subsequent graduate work in the Schools of Chemistry and Medicinal Chemistry and Pharmacology at Purdue University. His 32-year career at Eli Lilly and Co. includes work in technical support for bulk drug substance manufacturing; process development for bulk drug substance manufacturing; quality and regulatory affairs; and pharmaceutical packaging development. His current position as an associate consultant in Lilly’s Global Packaging Technology and Development group involves support for global registration activities for new solid-oral and injectable formulation drug product container closure systems at Lilly. He provides coordination of the company’s review and implementation of global compendial and guidance changes. He has developed methods for testing packaging components and systems for tracking packaging component attributes. Sparks has a broad expertise in post-approval changes and the associated FDA guidance. He was a charter member of a Task Group that organized the Drug Master File Workshop for Industry and FDA held in March 2002. This Task Group published Proposed Guidelines for Type-III DMFs.