Those of you from Pharma, and chemical synthetic industries; will be familiar with the routine and the process. Synthetic chemists produce some small, medium or large scale; matrix of substances and they want to have answers to the following questions “Have I made what I thought I made, how pure is it, and how much did I actually make?” For decades we have invested time, effort, energy, money and manpower into the act of acquiring data to support these questions. The methodologies and instrumentation have changed over the years, but the ultimate need has been an ever present and an important requirement.
For those not so familiar with these industries and processes, Pharmaceuticals, Agrochemical industries, and most chemistry development companies specialize in the need to produce new chemicals typically targeted to solve some challenge or problem; such as treatment of disease, eradication of weeds or insects and the like. During the development of these new chemicals, lots of testing, including Chromatography and mass spectrometry must be done before the compound is allowed to be commercialized. One small piece of this process right at the very beginning; is to ensure that the chemists made what they thought they had and know how much they made in the process. It is all very well to say I have 1 Kg of a chemical but if it is only 5% pure and the wrong chemical substance, then its value is significantly diminished or nothing. Analytical processes are present to determine such information.
Within many these organizations small, medium and large, we operate within a chain of responsibility, trust and respect, of the results that have been generated in all previous stages of the process. We have too, otherwise our systems would fail to continue being effective. So as part of this chain, I’d like to ask opinions on the need for checking or review of results arising from of our analytical testing of our compound confirmation processes. I’d like to also ask what opinions exist in respect of the importance of accuracy of processing for compound QC screening.
To start with, some indication of my bias might be warranted. As an analytical chemist myself by training, I am concerned about the quality of the results which either I create or I review or have to make conclusions from. So when presented with some series of results, I want to be sure of how these results came to be and what is my level of trust in those results, but at what cost do we do this? By cost I mean time, money and our already challenged teams of the people and scientists who must do this work.
So some questions that I would like to put out there are:
- Does performing physical review of the analytical QC results for compound synthesis make a difference at the level of chemists, laboratory and organizationally?
- Should this be a 100% check or some pseudo random review of some defined % of the samples acquired?
- Does this provide quantifiable value to an organization?
I’ll be following this thread up with a future blog about our experiences from colleagues and how such challenges and needs affects results in real laboratory situations.
Comments welcomed.