1. Scope

Keywords

Rationale

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); 4.2.2.1 Differentiating the level of microbiological control(s) as it proceeds from start to final release (e.g. sterility).