Recovery Studies – What the Heck?!

Hello, good people of the world! Recovery studies are studies to support surface swab processes. They typically involve “spiking” a “coupon” made from a particular material with a known amount of the contaminate you’re interested in, and then systematically quantifying the amount recovered via the swab process.

You’ll need to perform recovery studies for all product-contact materials you have in your manufacturing process. These typically include 316L stainless steel, PTFE, glass, etc.

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Quality 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

FDA CDER Inspections

FDA CDER

Based on FDA Compliance Program Guidance Manual Program 7356.002, located here.

Based on the program, there are 6 “systems” an FDA inspector may look at:

Stability – What is it and Why is it Important

Hello, good people of the world! Stability is the characteristic of your drug product to withstand degradation or changes due to environment factors, typically temperature, humidity, and light.

World Health Organisation (WHO) has published guidelines addressing drug stability since 1996. WHO introduced the concept of 4 climatic zones, derived from a scientific paper published in 1993: Grimm, W., Drug Development and Industrial Pharmacy (1993) 19:2795-2830.