Category Archives: Quality Systems

WHO’s Draft Guidelines on Validation May 2016

Hello good people of the world! On May 15, 2016, the World Health Organization released its draft Guidelines on Validation. It is available on the WHO website for download here.

This post covers my review of the guidance. Continue reading WHO’s Draft Guidelines on Validation May 2016

Quality During Construction

Construction Quality Assurance

Hello good people of the world! This blog post covers Construction Quality Assurance, based on an article that appeared in the Nov/Dec 2012 edition of Pharmaceutical Engineering titled “Assured Construction Quality Saves Time and Money.” All credit goes to the authors: Jay Lad of Skanska Pharmaceutical Group and Bruce Beck of Eli Lilly. Continue reading Quality During Construction

Revision to EudraLex Volume 4 August 2014

EU

Hello good people of the world! Another short post today, this one on the revision to EudraLex Volume 4 (GMPs) dated 13 August 2014. The revision is here. A short revision, the changes include updates to Chapter 3 (Premises and Equipment) and Chapter 5 (Production) around prevention of cross-contamination and qualification of suppliers.

Of note is the increased guidance around the use of quality risk management principles.

The revision will come into affect in March 2015.

What do you think of these changes? How will you adjust your quality program, if at all?

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Quality Metrics

Metrics
Metrics

Hello, good people of the world! If you know me, then you know I’m into “metrics” – ways to evaluate the health of a system or process quantitatively. We know finding and correctly interpreting the “right” metrics is not trivial, and looking at the “wrong” metrics can do more harm then good.

ISPE has recently released a whitepaper suggesting quality metrics for the FDA to use in their inspection process. I’ve uploaded a copy Continue reading Quality Metrics