Author(s): Satish L Kharad1*, Smita Rane, Nitesh Sharma, Rohit Velhankar
Journal: Journal of Pharmacy Research
ISSN 0974-6943
Volume: 4;
Issue: 8;
Start page: 2741;
Date: 2011;
Original page
Keywords: Quality By Design | Computer-Aided Process Design | Process Capability Index | New Drug Application | Process Parameter | Process Variability | Product Design | Quality Attribute | Question-Based Review.
ABSTRACT
In today era many pharmaceutical implement the quality by design system to obtain the high level of assurance of the product, for increasing the efficiency of manufacturing product & to reduce manufacturing cost and product rejection, the main aim of this is to design robust process. From my opinion it is important and necessary for developers to change their way of thinking that quality in the process not assure by inspection (QbI) it should be built in the design QbD. Implementing quality by design may reduce the overall approval time (time to approval +launch). QbD Pharmaceutical Product/Process is Design by using Basic Sciences, Mathematics and the Engineering Science with depth understanding of the interactions of the several variable such as raw materials, drug substance, manufacturing conditions, etc. and Facilitate manufacturing of a pharmaceutical product that will meet the desired patient needs and product performance requirements. QbD is necessary in regulatory requirement, Quality Overall Summary as part of a new drug application (NDA) and to implement new concepts such as QbD, design space, and real-time release contained in the International Conference on Harmonization’s guidance’s, Q8 PharmaceuticalDevelopment and Q9 Quality Risk Management and the FDA process analytical technology (PAT) guidance.
Journal: Journal of Pharmacy Research
ISSN 0974-6943
Volume: 4;
Issue: 8;
Start page: 2741;
Date: 2011;
Original page
Keywords: Quality By Design | Computer-Aided Process Design | Process Capability Index | New Drug Application | Process Parameter | Process Variability | Product Design | Quality Attribute | Question-Based Review.
ABSTRACT
In today era many pharmaceutical implement the quality by design system to obtain the high level of assurance of the product, for increasing the efficiency of manufacturing product & to reduce manufacturing cost and product rejection, the main aim of this is to design robust process. From my opinion it is important and necessary for developers to change their way of thinking that quality in the process not assure by inspection (QbI) it should be built in the design QbD. Implementing quality by design may reduce the overall approval time (time to approval +launch). QbD Pharmaceutical Product/Process is Design by using Basic Sciences, Mathematics and the Engineering Science with depth understanding of the interactions of the several variable such as raw materials, drug substance, manufacturing conditions, etc. and Facilitate manufacturing of a pharmaceutical product that will meet the desired patient needs and product performance requirements. QbD is necessary in regulatory requirement, Quality Overall Summary as part of a new drug application (NDA) and to implement new concepts such as QbD, design space, and real-time release contained in the International Conference on Harmonization’s guidance’s, Q8 PharmaceuticalDevelopment and Q9 Quality Risk Management and the FDA process analytical technology (PAT) guidance.
