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What is Sigmatech?

Sigma Tech 3.1 is software for achieving the objectives of QbD. It is useful for building quality into the process using the DOE technique. The statistically designed experimental data will be analyzed by this software to build the mathematical model and provide various simulation techniques for the optimal design of the process. This software is useful for applications in Analytical Research, Formulation, API, Chemical, and Process R&D laboratories within the Pharmaceutical, Biotechnology, and Chemical industries.

What is QbD?

QbD is a concept called ‘Quality by Design’, which aims to build quality into processes by design. This implies

What is DOE?

Why do we need to go for DOE in process development?

  • fdagv/cder/guidance/pv.htm
  • EMEA /INS/277260/ EMEA.EU.int
  • The pharmaceutical journal, vol 272, 5th June 2004, P 718

What happens if we do not use DOE in process development?

While developing the process, a process had to be developed quite often using a large number of variables (say about 7 to 10). Scientists usually use the OFAT method (one factor at a time approach) in developing a process. Since the number of variables is quite large and adoption of the OFAT method needs a large number of experimental trials, time, and resources, some of the variables are considered as not significant to the best of their knowledge. As a result, only 3 or 4 variables are tried in process development. This approach does not guarantee results. Even some variables are not significant. Their interactions with other variables might be significant in influencing the results.


Also, the conventional methods as followed in process development cannot establish the consistency and reproducibility of the results. The interactions of the process variables are quite strong in many processes and they create havoc in the process leading to inconsistent results. Further, among the process variables, some will influence the average performance and some others will influence the variation in the results. Due to the inability of the OFAT method, the factors affecting the average performance and the variation in the results cannot be established, and hence consistent and cost-optimal results cannot be achieved. Whatever is achieved with OFAT, the cost optimization cannot be proved.

Why is DOE not being followed in many Industries?

DOE methods were not part of the curriculum in many universities in the past. Several engineers and scientists who attended the appreciation courses in academic sessions were not ready to use DOE due to its detailed mathematical calculations. As a result, the OFAT method had been in use.

Some of the software packages that were made available later were not user friendly and were not in the sequence of process development steps. These factors made it difficult for scientist and engineers to adopt these methods. Sigma Tech software is user friendly and can be used easily with little training. It is designed in the sequence of process development steps.

Hence, Swaroop Tech Services Pvt. Ltd has been trying to spread these DOE methods in the Corporate R&D s in industry, Professional Institutions, and in academics by conducting various seminars and workshops through Sigma Tech software and guiding the Research Scholars through the use of Sigma Tech software in completing their project works.

What are the advantages of using DOE in process development?

Which organizations use DOE methods for process development?

What is AQbD?

AQbD means Analytical Quality by Design. Food and Drug Administration (FDA) has approved a few new drug applications (NDA) with regulatory flexibility for quality by design (QbD) based analytical approach. The concept of QbD applied to analytical method development is known now as AQbD (analytical quality by design).

How does it benefit the Analytical Method Development?

Unlike current methods, an analytical method developed using analytical quality by design (AQbD) approach reduces the number of out-of-trend (OOT) results and out-of-specification (OOS) results due to the robustness of the method within the region. It allows the analytical method for movement within a method operable design region (MODR) and does not call for approval from Regulators as long as the parameters are changed within the MODR.

What happens if we use the current practice of Analytical Method Development?

In current practice, the implemented analytical methods were based on one factor at a time (OFAT), in which one parameter alone is optimized for the expected response whilst others remained constant. This practice always yielded a narrow robust behavior of the method for instrumental variables used in the method development phase. Hence the present strategy of analytical method (i.e., OFAT) development has a high risk of method failure and always requires re-validation protocol after method transfer or alternative method development; thereby it has been increasing the cost of the method.
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