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USP General Chapter <660>—Glass revised

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To create opportunity for glass innovation, the Packaging and Distribution Expert Committee (PD EC) revised the United States Pharmacopeia (USP) General Chapter <660>—Glass.

USP General Chapter —Glass revised - container packaging

In response to supply chain challenges, including shortages of critical glass vials for products like COVID-19 vaccines and parenteral drugs, the Packaging and Distribution Expert Committee (PD EC) has made a significant revision of United States Pharmacopeia (USP) General Chapter <660>—Glass.

 

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On 1 October 2023, the final, official version of the chapter was published.

Glass container manufacturing

This change follows the USP’s Compendial Notice from January 2023, in which the PD EC announced that it intended to revise the General Chapter. The US Food and Drug Administration (FDA) had, in November 2022, requested revision of the Type 1 definition of glass in General Chapter <660>.

The FDA’s letter recommended that glass be “defined by its performance characteristics and not solely on its composition [to] allow for innovation in the manufacturing of glass intended for parenteral packaging.” In the document, it was reasoned that global shortage of these vials threatened the delivery of COVID-19 vaccines and availability of existing parenteral products.

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Another USP Compendial Notice from January 2023 highlighted a need to use appropriate language in several of its monographs to support manufacturing flexibility of parenteral products. It noted that there are “about 380 USP monographs for parenteral products… [and] about 330 monographs that prescribe a specific type(s) of glass in the Packaging and storage section”.

Therefore, in February 2023, the organisation proposed that the compendial revisions include the term ‘preferably’ in relation to how these products are packaged. For example:

  • Preserve in single-dose containers, preferably of Type I glass
  • Preserve in single-dose or in multiple-dose containers, preferably of Type I or Type II glass.

According to USP, having been accelerated to create opportunity for glass innovation, the revision including different compositions beyond borosilicate and soda-lime-silica.

The PD EC plans to publish another major revision to <660> to modernise the testing procedures in the chapter, USP stated.

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