Thursday, 23 June 2016

Pharmaciopeial Forum Vol. 42 No.3


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.

The second section, Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products, is meant to support the use and understanding of the new chapter Plastic Components and Systems Used in Pharmaceutical Manufacturing 661.3, appearing in the current PF.

Posted by Dr. Tim Sandle