regulatory and industry views on quality by design

1. REGULATORY AND INDUSTRY VIEWS ON
QUALITY BY DESIGN
Presented by :
NISHA N.
2nd SEM M . PHARM
Dept . Of Pharmaceutics

2. CONTENTS :
1) INTRODUCTION
2) REGULATORY VIEWS ON QBD
3) QBD FACILITIES
4) INDUSTRY VIEW ON QBD

3. INTRODUCTION :
DEFINITION :
The pharmaceutical quality by design is a systematic
approach to development that begins with predefined objectives
and emphasizes product and process understanding and process
control based on sound science and quality risk management .
• QBD has been developed by U.S. Food and Drug Administration
( FDA) for the discovery , development and manufacture of drugs
• QBD is a concept introduced by the International conference of
Harmonization (ICH) Q8 guidelines .

4. AIM OF QBD
• Design a quality product .
• Quality aim of manufacturing process .
• Product should meet patients need .
• Product development may vary between products .

5. Regulatory views on QBD
As defined by the FDA official ( Woodcock , 2004 )
“ The QBD concept represent performance
characteristics scientifically designed to meet specific
objectives , not merely empirically derived from
performance of test batches .
“ Another FDA representative ( Shah , 2009 ) states that
introduction of the QBD concept can lead to cost savings
and efficiency improvement for both industry and
regulators “ .

7. • EMA representatives point out that it is preferable for a
design space to be complemented by an appropriate control
strategy .
• The review of various regulations and the revised
variations classification guidelines has taken into account
QBD submissions , to enable easier updates of the
registration dossier .
• EMA templates and guidance documents used for the
assessment of any new drug application in the centralised
procedure include the possibility of design space
appointment .

8. INDUSTRY VIEW ON QBD
• Pfizer was one of the first companies to implement
QBD and PAT concepts .
• Through these concepts , the company enhanced
process understanding , higher process capability ,
better product quality and increased flexibilty to
implement continous improvement change .