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

Ship It! Shipping Qualification 101


Shipping Qualification is one part of the qualification of a drug’s supply chain qualification that protects the quality of a regulated drug product. Other parts include qualifying/auditing suppliers, testing raw materials, manufacturing processes, warehousing, etc.

Shipping Qualification focuses on the parameters that may affect critical quality attributes such as temperature, humidity, light exposure, vibration exposure, etc. You must know your product and the risks associated to it through each of these avenues.

Shipping Qualification is particularly important because some degree of control is lost in shipping product, and the new risks must be understood and mitigated if not acceptable. Continue reading Ship It! Shipping Qualification 101

ISO 14644 – What it is.


ISO is the International Organization for Standardization, based in Geneva Switzerland1. You may have heard of ISO 9000/9001 certification, which covers general quality management systems, but there are many more ISO standards – more than 10,000 total standards available at the time of this writing (September 2013), covering everything from IT systems configuration to milk production to statistical methods.2

A bummer, to me at least, is that the standards are not free, and they are not cheap. Copies of standards in electronic (PDF) or paper form can be purchased from the ISO website ( in Swiss Francs, or from ANSI3 or IEST4 in American Dollars. The 18 page ISO 14644-1 will cost you around $100. Note that the copy is for individual use only, not to be shared. Needless to say, to get yourself a complete set of ISO standards would cost you a pretty penny. Continue reading ISO 14644 – What it is.