Quality-by-Design in Pharmaceutical Product Development

Last year at Drug Delivery Partnerships, Chetan Pujara, Ph.D. Senior Director, Small Molecule Product Development, Pharmaceutical Development, Global Pharmaceutical Sciences, Allergan presented on "Quality-by-Design and Quality Risk Management in Pharmaceutical Product Planning". Below is a brief teaser of the presentation - in order to view the complete presentation, click here. 

Pharmaceutical Development
To design a quality product and its manufacturing process to deliver the intended performance of the product.

Quality by Design
QbD is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding based on sound science and quality risk management

Overall Principle of this approach:
Quality cannot be tested into products; i.e.,
Quality should be built in by design.

Key Principles of QbD
• Systematic approach to
   – Product design
   – Process design & control
   – Process performance & continuous improvement
• Quality: Quality cannot be tested in the product; it should be built in by design
• Product Knowledge: Scientific understanding in the establishment of design, specifications and manufacturing
• Regulatory Flexibility
   – Design space proposed by applicant is subject to regulatory assessment and working within the space is not a change
   – Movement out of design space is considered to be a change and requires post-approval change process

Is QbD really a new concept?
• QbD is not a new concept from the technology perspective
• QbD is new relative to regulatory review and submission
• QbD is optional and should not become a regulatory requirement as agreed to in ICH Q8
• QbD will not necessarily be included in all submissions
• Generation of QbD information during IND phases should be at industry discretion

7 Step QbD Process for Pharmaceutical Product Development
1. Quality target product profile
2. Identify approach to drug product formulation/manufacturing process.
3. Identify potential Critical Quality Attributes of RM/DS/DP
4. Identify potential Critical Process Parameters
5. Using risk assessment & experimental approaches, determine the functional relationships that link raw material CQAs and unit operation CPPs to drug product CQAs
6. Refine formulation and manufacturing process, if necessary and repeat steps 3 -5 to meet QTPP defined in Step 1.
7. Establish Design Space and Control Strategy


Be sure to join us at Drug Delivery Partnerships 2015 to hear from Sesha Neervannan PhD, Vice President, Pharmaceutical Development, Allergan who is on the 2015 DDP Advisory Board.

Register before Friday 12/19 and save $300 - Use the code XP2078BLOG to save!

Register here.