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
Posted by Tim Sandle
No comments:
Post a Comment
Pharmaceutical Microbiology Resources