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.

Quality 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

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. Continue reading Stability – What is it and Why is it Important

Parts Washer Qualification – PQ

Parts Washer

This post is about Parts Washer qualification. This covers any manner of automated system that cleans parts out-of-place (Clean-out-of-place = COP). This includes process parts washers, glassware  washers, laboratory parts washers, etc. all of which may be termed COP washers.

The scope of a performance qualification of a washer is the performance of the equipment with defined recipe(s) and load(s). Be sure to capture the recipe and load configuration in the protocol prior to execution or as part of the execution itself. This is how the recipe and load configuration become “validated.” The recipe includes all steps and parameter values, and the load includes what parts or components will be washed and how they will be arranged. You’ll need to include a picture or diagram. Continue reading Parts Washer Qualification – PQ

Is it Possible? Validating Excel Spreadsheets


Shocking news on the Internet:

88% of spreadsheets have errors. Assuming this is true, and the pharma, biotech, and med devices are not immune, we could have quite an issue at hand.

Spreadsheets (especially Microsoft Excel) are pervasive in office environments, and there’s no doubt Excel spreadsheets are employed for GMP uses.

One of the principle concerns is the Microsoft Excel is not 21 CFR Part 11 complaint out of the box, in that it does not include an audit trail or electronic signature. Does this mean Excel should not be used for any GMP purpose? Continue reading Is it Possible? Validating Excel Spreadsheets

The Validation Master Plan


The first question you may ask is: Is a validation master plan required to be compliant with the cGMPs?

The literal answer is no, in fact no regulation specifically calls for a VMP and the only guidance in which the concept shows up is PIC/S’ document PI-006-03, although ISPE has been using the term as early as 1998 (see ISPE Baseline Guide volume 2, first edition, 1998). Euralex Volume 4, Annex 15, published in 2001 references the PIC/S guidance and formalizes the VMP as an integral part of “planning for validation.”

However, I’ve never seen an FDA warning letter that cites the lack of a validation master plan, but there are warning letters dealing with issues in a company’s VMP or failure to follow their own VMP.

Does that mean you shouldn’t waste your time? Continue reading The Validation Master Plan