#USP Tag

31 Mar

Posted at 12:20h in Blog

As shortages of glass vials have been reported in the past years, to address concerns about the supply of such packaging materials, the USP intends to revise the packaging and storage statements in several USP monographs for parenteral products which currently prescribe a specific type of glass.

Several official monographs in the USP-NF require the use of a specific glass type, for example “Type I glass” or “Type II glass.” Current General Chapter <660> Containers – Glass defines glass types by composition-based characteristics.

According to the general announcement, the revision of the monographs should provide some level of flexibility regarding the type of packaging by including a reference to a preferable type of glass for packaging, rather than prescribing a specific type of packaging material.

To address challenges, the proposed compendial revisions would include the following:

  1. Revisions to General Chapter <660> to remove glass classifications based on composition. Currently, <660> defines: Type I (borosilicate glass); Type II (treated soda-lime silica); and Type III (soda-lime silica). Under the proposal, General Chapter <660> would instead define glass Types I, II, and III by performance characteristics, allowing for additional compositions to be considered Type I, II, and III glass.
  2. Revisions to 14 monographs that currently prescribe a specific glass type by adding the word “preferably” in the packaging section of the monograph.” The addition of the word “preferably” to the monographs at issue means that the use of the glass specified is preferred, but not required. This proposed revision will give manufacturers additional flexibility in their choice of packaging and pave the way for new or different types of packaging to be approved.

 

Conclusions

To introduce more flexibility for manufacturers and regulators, the USP is therefore proposing the addition of the word “preferably” to the packaging and storage statements in the monographs that currently use prescriptive language. However, additional changes to many monographs may be needed to fully address the paradigm shift in defining suitable packaging materials for parenteral products.

SOURCES:

Notice of Intent to Revise: Proposal to Add Flexibility in the Selection of Suitable Packaging and Storage for Parenteral Drugs.

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22 Sep

Posted at 15:25h in Blog

The United States Pharmacopeia (USP) is making important changes to series of chapters on Good Storage and Distribution Practices <1079> that will impact risk mitigation strategies for storage and transportation of finished pharmaceuticals.

This chapter focuses on packaging, storage, and transportation processes that maintain drug product quality and supply chain integrity. The proposed revision identifies common risks in the storage and transportation of drug products and recommends appropriate mitigation strategies.

The new USP <1079> changes are significant and highlight the need for companies who will store, handle or transport products with label temperature requirements to meet a thorough Quality Management System (QMS). USP <1079> defines good storage and distribution practices for temperature sensitive drugs during all stages of the cold chain.

The existing chapter is titled “Good Storage and Distribution for Drug Products.” The new proposed chapter title will be – “Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products.”

The <1079> Series

The current plan for the expanded series is as follows:

Chapters <1079> and <1079.2> are already effective. For <1079.3>, a draft is available for comments.

USP <1079.2>

The sub-chapter <1079.2> addresses the utility and application of mean kinetic temperature (MKT) for the evaluation of temperature excursion in controlled room temperature (CRT) and controlled cold temperature (CCT) products.

USP <1079.3>

Is a new sub-chapter. It provides background information about the science and technology of temperature and humidity monitoring over time. It also describes the available technologies and performance characteristics and provides recommendations for qualifying performance.

Sub-chapter <1118> “Monitoring Devices—Time, Temperature, and Humidity” will be omitted, as the information will be included in the new sub-chapter <1079.3>.

USP <1079.4>

<1079.4> is also a new chapter, which was first published for comments in the Pharmacopeial Forum, PF 48(5), in September 2022.

The draft versions of all proposed new chapters are available in PF Online.

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