Friday, 13 November 2015

Pharmacopeial Forum 41 (5)


A new edition of the Pharmacopeial Forum has been issued.  This is volume 41, issue 5, which covers the period September – October 2015.

Highlights include:

Chapter 1 Injections and Implanted Drug Products (Parenterals) – Product Quality Tests
(Revision proposal target, USP39-NF34 2nd Supplement) - change to chapter name and update to text.

There are five USP general chapters that link with USP's taxonomy for pharmaceutical dosage forms: Injections and Implanted Drug Products 1, Oral Drug Products—Product Quality Tests 2, Topical and Transdermal Drug Products—Product Quality Tests 3, Mucosal Drug Products—Product Quality Tests 4, and Inhalation and Nasal Drug Products—General Information and Product Quality Tests 5. The five general chapters provide critical product quality attributes for the various dosage forms by the various routes of administration.

Chapter 1029 Good Documentation Guidelines
(Revision proposal target, USP39-NF34 2nd Supplement)

This proposed new general chapter provides guidelines on how to develop and maintain good documentation practices within Good Manufacturing Practice (GMP) operations.

Chapter 1228.3 Depyrogenation by Filtration
(Revision proposal target, USP39-NF34 2nd Supplement)
 This is an additional general chapter to the Depyrogenation 1228 family of chapters. This chapter provides an overview of depyrogenation by filtration and the various approaches and technologies used to complete it

Chapter 1228.5 Endotoxin Indicators for Depyrogenation [NEW]
(Revision proposal target, USP39-NF34 2nd Supplement)
 This is an additional general chapter to the Depyrogenation 1228 family of chapters. In this chapter the biological tool used to challenge the depyrogenating capabilities of a process will be defined as an endotoxin indicator. The following topics will be discussed in this chapter: endotoxin and lipopolysaccharide, applications of endotoxin indicators, preparation and use of endotoxin indicators, and analysis of test results.

Chapter 1229.13 Sterilization-in-place [NEW]
(Revision proposal target, USP39-NF34 2nd Supplement)
A new general chapter as an addition to the Sterilization of Compendial Articles 1229 family of chapters. This chapter discusses sterilization of a system or piece of process equipment in situ (sterilization-in-place; SIP) to reduce the need for post-sterilization handling. This chapter provides information on the common elements of the SIP process, different physical methods used for performing SIP, and routine process control

Chapter 1231 Water for Pharmaceutical Purposes
(Revision proposal target, USP39-NF34 2nd Supplement)

The following list includes a summary of the changes:


Updating the chapter to improve the organization and clarity of the information and remove redundant discussion text. This includes the organization into nine specific sections listed below.
Removing wording redundant to referenced monograph wording.
3Adding a detailed Outline/Table of Contents to improve user's topic discussion findability (topics will be hyperlinked in future electronic USP versions).

Significant revisions have been made or discussion added in several reorganized sections: 1. Introduction; 2. Source Water Considerations; 3. Waters Used for Pharmaceutical Manufacturing and Testing Purposes; 4. Validation and Qualification of Water Purification, Storage, and Distribution Systems; 5. Design and Operation of Purified Water and Water for Injection Systems; 6. Sampling; 8. Microbial Considerations; and 9. Alert and Action Levels and Specifications. The remaining section 7. Chemical Evaluations is not being revised at this time.

Posted by Dr. Tim Sandle