Pharmacopeial Forum 42 (5)

A new edition of the Pharmacopeial Forum Vol. 42, No.5, has been issued. Items of interest include:

Chapter197  Spectrophotometric Identification Tests

Proposed revisions:

1.         A title change is proposed.

2.         A new section, Introduction and Scope is proposed.

3.         A new section, Identification Methodology, is proposed.

4.         A section heading change from Infrared Absorption to Infrared Spectroscopy is proposed.

5.         Technical and editorial revisions for Infrared Spectroscopy are proposed. The main technical revision for this section allows the comparison of the spectrum of the test specimen to the spectrum of the USP Reference Standard previously recorded.

6.         A new section, Near-Infrared and Raman Spectroscopy, is proposed.

7.         A section heading change from Ultraviolet Absorption to Ultraviolet-Visible Spectroscopy is proposed.

8.         A new section, X-ray Powder Diffraction Spectroscopy, is proposed.

9.         A new section, Equivalent/Alternative Tests, is proposed.

Chapter 1210 Statistical Tools for Procedure Validation [NEW]

Proposed revision details:

This chapter is proposed as a companion to Validation of Compendial Procedures 〈1225〉 with the purpose of providing statistical methods that can be used in the validation of analytical procedures. Specifically, this revision clarifies the accuracy and precision calculations while removing specific linearity requirements. Linearity may be inferred from accuracy or other statistical methods as deemed appropriate. This chapter discusses all of the following analytical performance characteristics from a statistical perspective: accuracy, precision, range, detection limit, quantitation limit, and linearity. Additional related topics that are discussed in this proposed chapter include statistical power, two one-sided test of statistical equivalence, tolerance intervals, and prediction intervals.

Chapter 121 >            Sterilization and Sterility Assurance of Compendial Articles

There were two main objectives in updating this chapter. One was to make sure current information was accurate. The other objective was to develop a new format for the information, with improved organization of specific topics. It was decided to accomplish the update in two phases. The two-stage revision started in the last USP cycle (2010–2015). The initial focus of the revision was on the sterilization aspects of the chapter, to be followed by revision of content relevant to sterility assurance. In considering how to update 〈1211〉, which has its origins in the late 1980s, it was decided to split the chapter, separating out the sterilization content by moving it to a new chapter family, Sterilization of Compendial Articles 〈1229〉. The content on sterility assurance is remaining in 〈1211〉, and the chapter is being renamed Sterility Assurance 〈1211〉. With the development of the 〈1229〉 family of chapters, focused on the various sterilization processes, now nearly complete, the focus of the future 〈1211〉 will be limited to sterility assurance. This draft proposal, which is a major revision to the existing 〈1211〉, is a short-term fix while a complete rewrite is under development.

Additionally, minor editorial changes have been made to update this chapter to current USP style.

The following Briefing list includes monographs and/or chapters that both reference the General Chapter under revision and require revision to keep references to the General Chapter accurate. Other monographs and/or chapters may also be listed, even where the reference to the General Chapter remains unchanged, as additional notice to stakeholders where there is believed to be potential for the change in the general chapter itself to affect pass-fail determinations for particular monograph articles

Chapter 1229.14 Sterilization Cycle Development [NEW]

This new chapter is an addition to the Sterilization of Compendial Articles 〈1229〉 family of chapters. Sterilization is not only a means to eliminate microorganisms, but is also a process that may alter materials and thereby impact usefulness, safety, or both. The correct development and implementation of a sterilization process involves a number of important steps. This chapter provides an overview of those steps and the general principles involved in the development of a sterilization cycle.

Chapter 1229.15 Sterilizing Filtration of Gases [NEW]

This new chapter is an addition to the Sterilization of Compendial Articles 〈1229〉 family of chapters. Sterilization processes are broadly divided into two categories: destruction of microorganisms and physical removal of those microorganisms from the material being sterilized. Autoclaving is an example of the former, and sterilizing filtration is an example of the latter. The sterilization of gases that contact sterile components, container and closures, and product contact surfaces of processing equipment is typically accomplished by passing the gas through one or more sterilizing-grade membrane filters. This proposed chapter provides an overview of the general principles involved in the sterilizing filtration of gases, including the types of filters used, the retention mechanisms, and the validation of the filtration process.



Posted by Dr. Tim Sandle