Type of Posting: General Announcement
Posting Date: 29-Mar-2024
Input Deadline: 27-Jun-2024
Expert Committee: General Chapters – Microbiology
Suggested Audience: Suppliers and manufacturers of drug substances, pharmaceutical manufacturers, contract manufacturing and testing organizations, regulatory agencies, and QA/QC specialists.
Background and Objective:
The United States Pharmacopeia (USP) is dedicated to ensuring the highest level of microbiological quality in nonsterile pharmaceutical products. As part of this commitment, we are proposing a new compendial approach for the implementation of <60> Microbiological Examination of Nonsterile Products ̶Tests for Burkholderia Cepacia Complex (BCC).
A critical aspect of pharmaceutical quality is the mitigation of risks associated with microbiological contamination. BCC represents a significant concern due to its ability to survive in various environments and its association with serious adverse events. The FDA has highlighted the importance of robust testing for BCC in aqueous non-sterile products1. In order to strengthen our collective defense against such risks, the USP is planning to revise several General Chapters to clarify the application of this test.
Proposed Compendial Approach:
This approach emphasizes the inclusion of essential local text within harmonized chapters, ensuring the applicability of BCC tests to products for inhalation use or aqueous preparations for oral, oromucosal, cutaneous, or nasal use. The proposed updates highlight the importance of ensuring that certain dosage forms are free from BCC to protect patient safety and product integrity.
USP is sharing the proposed plan towards a holistic framework for microbiological testing for Burkholderia cepacia complex. The approach consists of the following steps:
- Revise the General Chapter <62> Tests for Specified Microorganisms to include a requirement that products with a water activity of 0.6 or higher must be tested to demonstrate the absence of BCC as directed in General Chapter <60>. This will provide clearer guidance on when BCC testing is required.
- Update the following relevant Informational General Chapters:
a. Align <1111> Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use to reflect these requirements, ensuring that the application of BCC tests is addressed uniformly.
b. Revise <1112> Application of Water Activity Determination to Nonsterile Pharmaceutical Products for consistency. - PDG Collaboration: Work in close coordination with the Pharmaceutical Discussion Group (PDG) to harmonize standards on a global scale. Initially, the USP intends to include local text to <62> and <1111>.
- Update monographs: Review and revise monographs as necessary. USP is considering direct references to GC <60> for higher-risk products.
Preliminary Examples of Proposed Revisions: The following examples include the proposed wording intended for inclusion in <62> Tests for Specified Microorganisms and potential revisions to Table 1 in <1111> Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use.
In anticipation of collaborative discussions, we look forward to engaging with regulatory agencies and global pharmacopeias to harmonize and enhance microbiological testing standards.
Deadline for Submitting Comments
USP welcomes your feedback and encourages you to submit your comments within 90 days from the post of this announcement by email, as described below.
Submitting Your Comments
Please submit your comments to microbiology@usp.org
USP Contact Information
For further information, please contact Leslie Furr, Senior Scientist II, USP General Chapters, at leslie.furr@usp.org or microbiology@usp.org.