BRIEFING

 〈1119.1〉 Bioburden Test. The General Chapters—Microbiology Expert Committee proposes this new chapter for the testing of bioburden. Historically, there has been an erroneous assumption that Microbial Enumeration Tests 〈61〉 could be applied as a generic test for bioburden for a wide variety of sample types. This interpretation had been supported in Monitoring of Bioburden 〈1229.3〉, which stated that qualification of a modified version of 〈61〉 might be appropriate for the testing of bioburden yet failed to provide specific details. Chapter 〈61〉 is a test specifically for the release of nonsterile finished drug products and associated substances for pharmaceutical use as stipulated in Microbiological Acceptance Criteria for Nonsterile Pharmaceutical Preparations and Substances for Pharmaceutical Use 〈1111〉. In contrast, this chapter provides a proposed method that may be used as a generic bioburden test for purposes other than release testing of nonsterile products. An informational chapter, Bioburden Monitoring 〈1119〉, contains additional information regarding scope, sampling, and acceptance limits, which also appears in this issue of PF.

 Additional proposals in this issue of PF include:

1. Addition of a new chapter, Bioburden Monitoring 〈1119〉.

2. Omission of an existing chapter, Monitoring of Bioburden 〈1229.3〉.

 (GCM: L. Furr)

 Correspondence Number—C326398