Thursday, 13 November 2014

Pharmacopeial Forum Vol. 40 No.5: Sep– Oct 2014

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)

A new general information chapter is proposed as a companion chapter to Validation of Compendial Procedures, <1225> with the purpose of providing statistical methods that can be used in the validation of analytical procedures.

Posted by Tim Sandle