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INTRODUCTION:
The word quality was derived from the Latin word ‘Qualitus’ that suggests excellence or totally different feature. Quality is nothing however the suitableness of either a drug substance or product for its desired purpose.1 Quality is one in all the vital aspects while developing a new product in the pharmaceutical industry.2
To design quality product and its production technology are one of the main motives of pharmaceutical product development for continuously delivering desired performance of the product.3 In earlier days, the quality of the pharmaceutical products was solely supported its testing. From an entire batch of the pharmaceutical product, randomly a little quantity of the sample was taken for the aim of testing and then the results were analyzed and hence the quality of that product was taken under consideration. However, the quality of every unit of the dosage form is extremely vital in respect to the end user’s intended purpose. So, currently the concept of ‘Quality by design’ is to be initiated so that the quality is inbuilt by design.4,5
Quality by design:
Quality by Design (QbD) is a current, scientific approach that standardizes product design, streamlines troubleshooting and automates manual testing. Rather than counting on finished product testing alone, QbD allow insights upstream throughout the development process. QbD requires the recognition of all critical formulation attributes and process parameters in addition as determinant the extent to that any variation may impact the quality or standard of the finished product.6
Definition [FDA PAT Guidelines, Sept. 2004]:
A method for planning, evaluating, and managing production through timely measurements (during processing) of vital quality and performance characteristics of novel and in-progress materials and processes, with the aim of assuring the safety of the finished product.7,8
Definition [ICH Q8 (R1)]:
a methodical approach to development that starts with predetermined goals and places an emphasis on process control, product and process understanding, and reliable science.8
Objectives of Quality by design:
The main objective of QbD is to attain the standard quality products. Other objectives are:
* To guarantee combination of product and process knowledge gained throughout the development.
* To bring off positive performance testing.9
* To increase product development and production efficiencies.
* To enhance product capability and scale back variability.
* To enhance root cause...