With the publication of the quality guideline ICH Q9 “Quality Risk Management” by the
International Conference on Harmonization, risk management has already become a …

Process validation is required by current good manufacturing practice (cGMP) regulations
for finished pharmaceuticals. The scope of process validation includes clean-in-place (CIP) …

Purpose–Quality management tools such as failure mode and effects analysis (FMEA) have
been implemented in various industries to improve quality. This report aims to demonstrate …

In the highly regulated pharmaceutical industry, significant risks to products/processes must
be formally identified, reduced, and controlled to minimize potential negative impacts on …

Abstract Nowadays, Quality Management tools such as failure mode and effect analysis
(FMEA) are widely used throughout the aeronautical, automotive, software, food services …

Pharmaceutical quality systems use various inputs to ensure product quality and prevent
failures that might have patient consequences. These inputs are generally data from failures …

Failure modes and effects analysis (FMEA) is a very powerful risk assessment tool widely
used in a variety of manufacturing industries and business practices. Like many risk analysis …

The most recent FDA (1) and International Conference on Harmonization (ICH)(2-4)
guidance documents advocate a new paradigm of process validation based on process …

Quality risk management principles are used effectively in many areas of business and
government--including finance, insurance, occupational safety and public health--and by the …

Summer 2010 BioProcessing Journal•• www. bioprocessingjournal. com 27 2000 that takes
a broad approach for identifying, evaluating, and mitigating risks: ISO 14971.[15] This is a …