How to prepare for ICH Q10 compliance

What is ICH Q10 compliance?  In 2001, a PWC report uncovered shocking levels of inefficiency and waste in the pharmaceutical world, with scrap and rework rates touching 10% and costs of poor quality exceeding 20%.

In 2003, FDA Commissioner Mark McClellan issued a damning assessment of drug manufacturing quality in the United States, labelling pharmaceutical quality management as less developed than that of potato chip and soap manufacturers. And in 2005, an IBM report found the average pharmaceutical process had an average sigma level of 4σ.

Pushing processes closer to 6σ with a robust QMS driven by continuous improvement and quality by design (QbD), the report suggested, could unlock cost savings of over $10 billion a year.