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. The concept of a Microbiological Quality Level (MQL) has been proposed as a mechanism that can be developed and used for:
- Determining the acceptable level of microbial contamination permitted during the manufacturing of or on a finished pharmaceutical, biopharmaceutical or combination product.
- A level established based on critical microbiological quality attributes and acceptance criteria for the product (i.e. specifications).
- A level, when met, delivers a high degree of confidence in acceptability of the process step and/or product.
This workshop is intended to gain alignment and provide the guidance from industry on understanding the different levels of product and process controls, their impact on the microbiological quality and the ability to determine a level of confidence in the output of a process including:
- Understanding the Microbiological Quality Spectrum: from non-sterile to sterile and throughout the end to end manufacturing process;
- 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);
- A means of determining probability/quantification of microbial risk for each step and its contribution to the final product;
- A standard approach for the determination and evaluation for each process critical control point and critical microbiological quality attribute;
- A standard approach for trending to support demonstration of a state of control;
- A mechanism to differentiate the microbiological quality of finshed product.
The output of the workshop will provide the foundation and road map for creating an international industry consensus standard for microbiological quality level being developed under ASTM Committee E55 on the Manufacture of Pharmaceutical and Biopharmaceutical Products.
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