Wednesday, 15 July 2015

Pharmacopeial Forum 41(3)


A new edition of the Pharmacopeial Forum has been issued. Of interest are the following general chapters:

<659>  Packaging and Storage Requirements
(Revision proposal target, USP39-NF34 1st Supplement)

USP proposes a revision to this chapter to update and clarify definitions related to proper packaging and storage.


<791>  pH
(Revision proposal target, USP39-NF34 1st Supplement)

The revision proposal harmonizes some terminology for consistency with other pharmacopoeia and explicitly permits more calibration options. There are no revisions to the instrument performance requirements or calibration procedures.

<1035>            Biological Indicators for Sterilization
(Revision proposal target, USP39-NF34 1st Supplement)


This chapter is proposed for omission from USP. A new general chapter, Biological Indicators for Sterilization <1229.5>, has been proposed in PF 41(2) as part of the new series of chapters on sterilization. The chapters impacted are Sterilization and Sterility Assurance of Compendial Articles <1211>, Pharmaceutical Compounding—Sterile Preparations <797>, and Sterility Testing—Validation of Isolator Systems <1208>. In these chapters, references to <1035> will be replaced by <1229.5>.

<1058>Analytical Instrument Qualification
(Revision proposal target, USP39-NF34 1st Supplement)

USP propose the following revisions to this general information chapter:
  • The Introduction is being modified to include the classification of instruments previously included as a separate section.
  • Several other modifications are introduced in Qualification Phases under Analytical Instrument Qualification Process.
  • Changes are also proposed under Roles and Responsibilities, Software Validation, Change Control, and AIQ Documentation.
  • The Instrument Categories section is being deleted.
  • A new Glossary is being added.


In terms of USP monographs:

Sterile Water for Injection

This revision proposal deletes the option of the Oxidizable Substances test, and retains the Total Organic Carbon test that is specific to sterile waters.

Posted by Tim Sandle