A
new edition of the Pharmacopeia Forum has been issued. Among the items of
interest are:
Chapter 1041 - Biologics (Revision proposal target,
USP38-NF33 2nd Supplement)
USP
propose revision of this General Chapter to update definitions, references and
to explain compendial requirements and perspectives pertaining to this class of
products and future monographs. Chapter <1041> is cross-referenced in the
following general chapters and monographs.
General
Notices, 5.50.10 Units of Potency (Biological). These citations will remain as
written when the revised chapter text becomes official.
Chapter 1207 - Sterile Product Packaging – Integrity
Evaluation (Revision proposal target, USP38-NF33 2nd Supplement)
Chapter
1207 has been extensively revised and subdivided into four related chapters.
1207.1
- Package Integrity and Test Method Selection [NEW]
(Revision
proposal target, USP38-NF33 2nd Supplement)
This
proposed new general chapter describes a range of package integrity test
methods that are used for ensuring sterile package integrity. Different types
of package defects that cause leaks are described, and information about their
detection is provided. Limit of detection is discussed in detail for the
different leak test methods.
1207.2
- Package Integrity Leak Test Technologies [NEW]
(Revision
proposal target, USP38-NF33 2nd Supplement)
This
proposed new general information chapter provides information guiding the
selection and proper use of leak test technologies. These leak test methods are
divided into two major categories: deterministic and probabilistic. For each
leak test technology, the chapter provides a description and discusses
applications, test equipment, and test parameters.
1207.3
- Package Seal Quality Test Methods [NEW]
(Revision
proposal target, USP38-NF33 2nd Supplement)
This
proposed new general information chapter summarizes test methods useful for
characterizing and monitoring package seal quality. These methods are not leak
tests but provide additional data regarding package seal characteristics that
may affect package integrity and leakage. The purpose of this chapter is to
provide information to guide the selection and use of package seal quality test
technologies.
1210
- Statistical Tools for Procedure Validation [NEW]
(Revision
proposal target, USP38-NF33 2nd Supplement)
Posted by Tim Sandle
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