USP General Chapter <671> Containers Performance Testing: Request for Comment

The USP Packaging and Storage Expert Committee responds to industry�s comments on moisture permeation testing for drug product packaging.

 

The United States Pharmacopeia (USP) recently received comments from pharmaceutical companies concerning recent revisions to “General Chapter <671> Containers–Performance Testing,” which appeared in the Second Supplement of USP 30. This second supplement contained a revision to “General Chapter < 661> Containers,” which was split into <660> “Containers–Glass” and <661> “Containers–Plastic”; “General Chapter <671>” was renamed “Containers–Performance Testing.” The revisions also moved the container permeation and light transmission requirements for plastic bottles from USP <661> to USP <671>, including those for plastic containers that are used for manufacturer’s unopened multiple-unit packages and liquids packaged in PET and PETG bottles.

Prior to the revisions provided in the Second Supplement of USP 30, the standards in USP <671> applied to container closure systems used by pharmacies and packagers that supply repackaged drug products dispensed for prescriptions. That is, manufacturers’ unopened multiple-unit, single-unit, or unit-dose packages used to dispense a drug were exempt from the requirements of USP <671>. The recent revisions to USP <671> extended the standards from container closure systems used by pharmacies and packagers that supply repackaged drug products dispensed on prescription to include plastic containers and their components used to package regulated articles.

In the past, industry trends included alignment with the intent of USP <671> and demonstration that marketed product container closure systems met the requirements in spite of the limited scope of USP <671> (drugs being dispensed on prescription). In some cases, pharmaceutical companies utilized testing that was similar to the USP standards for characterizing their container closure systems. In either case, FDA requires that marketed product container closure systems provide adequate protection to the drug product to sustain its shelf life claims.

The revisions to USP <671> affected pharmaceutical packaging through a new requirement for containers under conditions of use (Phase 2 test requirements), setting a new standard. While the intent of the new standard had merit, the plan for implementation moved the pharmaceutical industry to respond. Prior to the effective date of the changes published in the second supplement of USP 30, USP published a Revision Bulletin on their Web site (www.usp.org/USPNF/notices/revisionGeneralChapter671.html).

The Revision Bulletin reported that USP received two formal appeals and two informal requests from pharmaceutical companies, all asking that USP cancel and retract the revised chapter owing to the additional Phase 2 test and other changes made to USP <671> after it had appeared in Pharmacopeial Forum (PF). After consideration of these requests and appeals, USP and the Executive Committee of the Council of Experts decided to retract the sections of USP <671> that appeared in the Second Supplement of USP 30, but were not published in PF 32 (4).

Subsequently, USP published portions of the change proposals as they appeared in the Second Supplement of USP 30, as well as additional proposals to change USP <671> in PF vol. 34(2) [Mar–Apr 2008]. These change proposals prompted additional comments, questions, and concerns from industry.

In the spring meeting of the USP Packaging and Storage Expert Committee, it was unanimously agreed that USP <671> needed to be completely rewritten in a manner that clearly executes the purpose of the chapter. The Expert Committee agreed that the chapter must provide a meaningful standard to industry. Because of the impact on testing and compliance, this effort will require input from pharmaceutical manufacturers, packagers and repackagers, packaging material manufacturers, testing laboratories, and consultants. The plan for chapter revision considers the entire scope of the chapter: performance standards for container closure systems for regulated articles.

INDUSTRY PARTICIPATION URGED

The involvement of industry representatives (pharmaceutical, packaging, and repackaging), testing laboratories, packaging material suppliers, and consultants is encouraged. Involvement necessitates awareness of the current standards, recent revisions, and the applications of each standard. The following questions are provided to provoke interest and encourage participation.

  1. How does your firm use the standards in USP <671>?
  2. What related standards are used in place of or in addition to the standards in USP <671>?
  3. How can these standards be revised to facilitate and accomplish requirements for container closure system suitability as described by FDA in its Guidance for Industry: Container Closure Systems for Packaging Drugs and Biologics (May 1999) and Questions and Answers (May 2002)?
  4. How do the standards in USP <671> relate to material specifications, container closure system performance criteria, suitability, product stability, and overall protection for the drug product throughout its intended shelf life?
  5. How can (and should) the scope of this chapter address permeation of container closure systems for conditions invoked throughout the entire supply chain?
  6. Should there be various standards for marketed product, repackaged, and prescription vial container closure systems?
  7. How would your firm benefit from a performance-based approach for this chapter, one similar to that described by USP in its on-line Compendial Notices dated April 23, 2008: “General Chapter on Inorganic Impurities: Heavy Metals” (www.usp.org/pdf/EN/USPNF/2008-04-10InorganicImpuritiesStim.pdf)?

Comments may include enumerated answers to the questions in the article, an expressed desire to provide data or information related to the questions in this article, or specific comments about the current standards in USP <671>. The deadline for this initial request for comments is October 15. Your comments are welcome and may be submitted to Desmond Hunt, PhD, The United States Pharmacopeial Convention Inc., by mail or e-mail to:

Desmond Hunt, PhD
12601 Twinbrook Pkwy.
Rockville, MD 20852

 

Your rating: None Average: 4.5 (2 votes)