A
new edition of the Pharmacopeial Forum has been issued. Of interest are the
following general chapters:
(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)
<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
Posted by Tim Sandle
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