Pharmaciopeial
Forum Vol. 42 No.3
The
Pharmacopeial Forum (draft texts relating to the USP) has been issued.
In
relation to volume 42 (2), dated May - June 2016, the following is of interest
to readers:
Chapter 621
Chromatography
(Revision
proposal target, USP40-NF35 1st Supplement)
Additional
changes are proposed for this chapter. Under System Suitability, Particle size
(HPLC), it is proposed to delete the statement indicating that the high
particle size in the “L” designation definition must be used when no particle
size is mentioned in the monograph. Under System Suitability, Flow rate (GC), a
proposed allowance for a linear velocity adjustment is being added.
Chapter 661.3
Plastic Components and Systems used in Pharmaceutical Manufacturing [proposed
new chapter]
(Revision
proposal target, USP40-NF35 1st Supplement)
This
new chapter is proposed to address the qualification of plastic components used
in the manufacture of both pharmaceutical and biopharmaceutical active
pharmaceutical ingredients (APIs) and drug products (DPs). To support the use
and understanding of this new general chapter, a section has been added to
Evaluation of Plastic Packaging and Manufacturing Systems and Their Materials
of Construction with respect to Their User Safety Impact 〈1661>This
section, Plastic Components and Systems Used to Manufacture Pharmaceutical Drug
Products, discusses material characterization and selection, and safety
qualifications of plastic components and systems used to manufacture drug
products.
This
chapter is part of a suite of chapters, including Plastic Packaging Systems and
Their Materials of Construction 〈661〉,
Plastic Materials of Construction 〈661.1〉,
Plastic Packaging Systems for Pharmaceutical Use 〈661.2〉,
and 〈1661〉.
Chapter 1058 Analytical Instrument Qualification [proposed
new chapter]
(Revision
proposal target, USP40-NF35 1st Supplement)
In
response to comments received the USP are proposing additional changes to this
general information chapter.
Chapter 1661 Evaluation of Plastic Packaging Systems and their
Materials of Construction with Respect to their User Safety Impact
(Revision
proposal target, USP40-NF35 1st Supplement)
This
chapter is being divided into two sections.
The
first section, Plastic Packaging Systems and Their Materials of Construction,
focuses on plastic materials of construction and packaging systems. The section
describes all of the plastic materials that are included in Plastic Materials
of Construction 〈661.1〉, the process of
materials assessment, along with the applicability and application of 〈661.1〉.
The chapter also goes on to discuss the importance of packaging system
assessment and qualification and how Plastic Packaging Systems for
Pharmaceutical Use 〈661.2〉 facilitates
this assessment. With this revision, four new polymer descriptions are being
added to the chapter [Polyamide 6; Polycarbonates; Poly(ethylene-vinyl
acetate); and Polyvinyl chloride, non-plasticized], which corresponds to the
addition of these materials to 〈661.1〉.
Posted by Dr. Tim Sandle
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