USP clarifies Requirements for Plastic Packaging Systems

Recommendation

15/16 November 2023

Serialization/Aggregation - Live Online Training
Requirements, Challenges & Solutions

The USP General Chapters—Packaging and Distribution Expert Committee (PDEC) is proposing a revision to the Scope section of chapter <661> Plastic Packaging Systems and Their Materials of Construction. The revised chapter will become official on December 1, 2025, along with the two chapters Plastic Materials of Construction <661.1> and Plastic Packaging Systems for Pharmaceutical Use <661.2>. The revision is published to clarify the testing expectations that are outlined in <661.1> and <661.2>.

USP Chapter <661> Testing Expectations

The following applies:

• Testing of plastic materials of construction to establish that they are well characterized and suitable for use in packaging components or systems is addressed in Plastic Materials of Construction <661.1>.
  
  
• Testing of packaging systems and components to establish that they are suited for their intended uses is addressed in Plastic Packaging Systems for Pharmaceutical Use <661.2>.

The requirements of <661> are met by performing applicable tests in <661.1> and/or by meeting the requirements of <661.2>.

Additionally, information received from the vendor of plastic packaging systems and their associated materials or components can facilitate suitability for use assessments, as such information may be appropriate additions to or surrogates for the results obtained by performing the tests.

More information on the scope, applicability, and other topics related to the <661> suite of general chapters is provided in the USP chapter <1661> Evaluation of Plastic Packaging Systems and Their Materials of Construction with Respect to Their User Safety Impact.

The draft for chapter <661> is published in Pharmacopeial Forum (PF) 49(1). The comment period runs until 31 March 2023.