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Tuesday, July 21, 2009

Quality by design in pharmaceuticals understaning concept of quality by design

What is concept of quality by design

This concept is misunderstood by many peoples , we are tyring to put this in a very simple words and we are giving a document published by FDA on quality by design concept ,for your reference you will find a link at the bottom of this article you can take printout of this and keep in your library.

In pharmaceuticals so far we put stress on after and in process inspections , put step of inspection at all points, assuring the process carried out is meeting the standards, product manufactured is meeting the standards,

But in the quality by design concept it is said that , instead giving stress on inspection rather you can plan the quality of your pharmaceutical dosage form that you are going to manufacture. It is a great concept , planning the quality of pharmaceuticals.
We know every thing about


1.Material

2.Machinery

3.Process

4.Controls.


1.Materials: You need to look in to the chemistry of the material , which is the important aspect of your raw material , (Related substance affecting the formulation) so knowing these we can plan the raw material quality.


This also involves designing your packaging material which will provide best quality product.



2.Machinery :- we know what is the best machinery for getting good quality product
There should not be any manual handling of material by man , every thing should be automatic process.



3.Process : We know which is the best process for our pharmaceutical dosage form. Think up on how you can develop it to best one , plan the process well , design the process well , which will design quality .



4. Controls :- You know which are the critical controls to be cheeked while the process is going on as well as before starting the manufacturing .
These process controls should be designed to yield best quality pharmaceuticals . automation of quality control process .


5.Where and how this concepts can be applied:-
Aria of implementation of quality by design concept is very broad and can be applied to each and very unit operations in pharmaceutical manufacturing .right from the chemistry, manufacturing, and controls.


Example while in compression of tablets, if there is higher or lower weight, your machine should alert you , and stop compression unless it is intervened and corrected. Here there is no scope for manual interference in passing deviation, machine has to be designed to yield the quality of product, which requires planning of what quality you want ,



This concept brings in lots of other science fields to help design the quality of drugs , pharmaceuticals.


FDA had invited pharmaceutical companies to participate in their pilot program which they say is to gain more information on and facilitate agency review of quality-by-design, risk-based approaches for manufacturing and developing guidelines for and principles of quality by design and risk management in pharmaceutical manufacturing.

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What is 21 CFR Part 11, US FDA guidelines requirements of FDA compliance and CFR 21 Part 11.


Here you will find FDA'S guideline document on quality by design concept

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GMP guidelines

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