quality by design 2009 v01

8/7/2019 Quality by Design 2009 v01

http://slidepdf.com/reader/full/quality-by-design-2009-v01 1/12

Bioanalytical Autumn School

London, UK20 November 2009

Quality by Design

Dr Siegfried Schmitt

Principal Consultant

PAREXEL Consulting



- 2 -

©2009, PAREXEL Consulting

Agenda

What is Quality by design (QbD) and how does it

apply to biopharmaceutical analysis?

Recent activities and developments

Benefits and risks of applying QbD

How / Why to implement QbD



- 3 -


The Purpose and Context

The ICH Q8 guidance describes the suggestedcontents for the 3.2.P.2 (Pharmaceutical

Development) section of a regulatory submission in

the ICH M4 Common Technical Document (CTD)

format.

www.ich.org

A systematic approach to development that begins with

predefined objectives and emphasizes product and processunderstanding and process control, based on sound science

and quality risk management.



- 4 -


The Purpose and Context continued

Design Space is defined as:

The multidimensional combination and interaction of input variables (e.g.,

material attributes) and process parameters that have been

demonstrated to provide assurance of quality.

Working within the design space is not considered as a change.Movement out of the design space is considered to be a change and

would normally initiate a regulatory post approval change process.

Design space is proposed by the applicant and is subject to regulatory

assessment and approval (ICH Q8).

The multidimensional combination and interaction of input variables and

process parameters that have been demonstrated to provide assurance

of quality

www.ich.org



- 5 -


The “Inventors”

Who is behind this?



- 6 -


The US FDA Perspective

Encourage industry to adopt QbD

Separate teams (parallel review) for QbD

submissions and applications

Ultimate goal: being able to link drug activity in the

human body to critical process and analyticalvariables



- 7 -


The European Perspective (PAT Team)

Mandate (general objective)

A forum for dialogue and understanding between Quality and Biologics

Working Parties and GMDP Inspectors Working Group to prepare a

harmonised approach in Europe on assessment of applications and

inspections of products/systems/facilities for Process Analytical

Technology, including Quality by Design principles and manufacturing

science in the context of PAT

Composition

Chair; 5 quality assessors (chemicals and biologicals); 4 GMP inspectors; chairs

of the QWP, BWP and GMDP IWG; observer from EDQM; EMEA staff (4).

1 delegate only (either quality assessor or GMP inspector) per involved country

Representation to cover both human and veterinary products expertise



- 8 -


The European Perspective (Links)

• PAT page (EMEA website):

http://www.emea.europa.eu/Inspections/PAThome.html

• QWP page (EMEA website):http://www.emea.europa.eu/Inspections/QWPhome.html

[email protected]



- 9 -


Perceived / Promised Benefits

For the pharmaceutical industry, QbD is a means of assuring the identity, purity, quality, and potency of a drug

as it relates to its efficacy. In practical terms, it means that

the product’s critical quality attributes (CQAs) and process

critical control points (PCCPs) must be identified andcharacterised.

Newer multivariate analytical methods and associated

multivariate calibration techniques often provide much more

effective PAT systems than the traditional techniquesemploying unidimensional analysis alone

J Pharm Innov (2007) 2:87–92



- 10 -


Recent Developments

Extension of the FDA QbD Pilot for Biologics 17 Sep 2009

quality by design 2009 v01

Documents