Work Item
ASTM WK89812

New Guide for Guide for Establishment of a Microbiological Quality Level for Pharmaceutical and Biopharmaceutical Products and Processes

1. Scope

1.1 This guides outlines the establishment and implementation of a mechanism to measure the state of control of each independent step within a manufacturing process to determine the collective level of risk to the overall microbiological quality of the process and/or product. The microbiological quality level will be:
1.1.1 Dependent upon the demonstrated level of control for critical microbial quality attributes (CmQA)
1.1.2 Demonstrated control through Quality Risk Management (QRM) or Quality by Design (QbD) to limit, exclude or eliminate the probability of microbial contamination.
1.1.3 Be quantitated by assessing and measuring the risk associated with independent steps of a manufacturing process or the combined risk of the entire manufacturing process to the product.
1.1.4 Dependent upon the microbiological risk to the patient from both the process and product perspective.


Microbiology; Sterility


4.1 The manufacturing of Pharmaceutical and BioPharmaceutical products has become increasingly complex and requires guidance for better determining "how to quantify” a level of microbial contamination control utilized for a process step and or finished product.
4.2 This document provides the industry guidance on understanding the different levels of control, their impact on the microbiological quality and the ability to determine a level of confidence in the output of a process.
4.2.1 Understanding the Microbiological Quality Spectrum: from non-sterile to sterile and throughout the end-to-end manufacturing process.
4.2.2 An integrated quality approach for process verification (end to end) and to support final product release (E.g., Food HACCP programs); Differentiating the level of microbiological control(s) as it proceeds from start to final release (e.g. sterility).

The title and scope are in draft form and are under development within this ASTM Committee.


Developed by Subcommittee: E55.14

Committee: E55

Staff Manager: Travis Murdock

Work Item Status

Date Initiated: 02-27-2024

Technical Contact: John Logar

Item: 000