Tuesday, 29 April 2014

Pharmacopeial Forum Update 40 (2)

The USP Pharmacopeial Forum has been updated. In the new issue 40 (2), the following changes will be of interest.

Chapter 1083  Good Distribution Practices (Revision proposal target, USP38-NF33 1st Supplement)

A new series of informational chapters describing various aspects of the pharmaceutical supply chain replaces that which appeared as an In-Process Revision in PF 38(2) but since then has been cancelled. USP is proposing this new series of Good Distribution Practices (GDP) general chapters, which were developed based on a review of two existing general chapters, Good Storage and Distribution Practices for Drug Products <1079> and Good Distribution Practices for Bulk Pharmaceutical Excipients <1197>, and the previously proposed general chapter Good Distribution Practices—Supply Chain Integrity <1083>. The new general chapters will cover material flow beginning with initial procurement and continuing throughout the supply chain to delivery to the end user for pharmaceutical components and products, medical devices, and dietary supplements. The chapters will address four main GDP topics—Quality Management System <1083.1>, Environmental Conditions Management <1083.2>, Good Importation and Exportation Practices <1083.3>, and Supply Chain Integrity and Security <1083.4>—highlighting best practices and principles.

Chapter 1083.1 Quality Management System (Revision proposal target, USP38-NF33 1st Supplement)

Chapter 1083.2 Environmental Conditions Management (Revision proposal target, USP38-NF33 1st Supplement)


Chapter 1083.3 Good Importation and Exportation Practices (Revision proposal target, USP38-NF33 1st Supplement)

Chapter 1083.4 Supply Chain Integrity and Security (Revision proposal target, USP38-NF33 1st Supplement)

Chapter 1228 Depyrogenation (Revision proposal target, USP38-NF33 1st Supplement)

As part of the revisions to USP general information chapter Sterilization and Sterility Assurance of Compendial Articles <1211> and the genesis of the <1229> series of chapters, the USP Microbiology Expert Committee decided to separate information on sterilization from depyrogenation. This new chapter provides an overview of depyrogenation and introduces different means of depyrogenation and factors to consider in the selection of an appropriate method, validation of a depyrogenation method, and routine depyrogenation process control.

Chapter 1229.11 Vapour Phase Sterilisation (Revision proposal target, USP38-NF33 1st Supplement)

The USP has proposed separating current general information chapter Sterilization and Sterility Assurance of Compendial Articles <1211> into several individual chapters [see the Stimuli article entitled “An Outline of Planned Changes to USP <1229> Sterilization and Sterility Assurance of Compendial Articles” in PF 38(2)]. Vapour sterilization systems are well suited for surface sterilization of heat sensitive materials. This chapter will provide an overview of vapour phase sterilization and its validation.

Posted by Tim Sandle