Quality by Design (QbD) is a concept applied to process manufacturing. In this context it can be utilized in every process such as quality control. Thus Analytical Quality by Design (AQbD) is born. It is an adoption of the toolset of QbD in developing, qualifying and monitoring methods in the analytical laboratory of pharmaceutical (and medical devices) manufacturers.

1. Analytical QualityByDesign
Dimitris Papamatthaiakis
Pharma Life-cycle Consultancy

2. Outline
 A little history..
 Regulatory news
 Analytical quality by design
 Analytical control strategy
 Analytical target profile
 Design of experiment
 Process risk management
 Target measurement uncertainty

3. Analytical
QualityBy
Design
Alittlehistory..
 “QBD” American Engineer 1970s
 Telecommunications, aviation, automobile
 USFDA 2004 initiative
 USFDA 2005 QS
 ICH Q8, Q9, Q10 2009
 USP <1220> 2017
 ICH Q12 2019

4. AnalyticalQuality By
Design
Regulatory news

5. Analytical
QualityBy
Design
Regulatorynews
 Regulatory worldwide not harmonized
i. A lot of confusion
ii. ISO, AOAC,USP, EP, IUPAC, FDA → Becoming
standardized
iii. New ICH Q12 and Q14 (currently on draft)
iv. Harmonising the scientific approaches
v. Principles of analytical method development and
validation
 Focus on good science
 Quality by Design / fitness for purpose

6. Analytical
QualityBy
Design
Regulatorynews
 Lifecycle approach
i. Managing methods through to ensure fit for purpose
ii. Regulatory flexibility for specs (Target Profile)
iii. Easy to discuss..
a. enhanced statistical required
b. industry is on “wait-and-see”
 Bayesian Statistics
i. Comprehensive framework for assessing producer’s and
consumer’s risk
ii. Permits inclusion of prior knowledge in making
predictions
 Target Measurement Uncertainty
i. Reportable values & measurement uncertainty
ii. Error budget calculations
iii. Decision Rules & guard bands principles

7. Analytical
QualityBy
Design
Regulatorynews
Design
QualifyVerify

8. Analytical
QualityBy
Design
Regulatorynews
Parameter Traditional PQbD AQbD
Approach Empirical Systemic Systemic
Quality
Assured by testing
product
Built by design &
scientific approach
Robustness &
reproducibility by
development
FDA submision Data for submision
Product knowledge and
process understanding
Product knowledge
and assuring ATP
Specifications Based on history
Based on product
performance
requirements
Based on method
performance ATP
criteria
Process
Frozen. Changes are
discouraged
Flexible. Design space
allows improvement
Flexible. MODR
allows improvement
Advantage Limited and simple
PAT control the process
through CPPs
Replacing
revalidation
Minimizing OOS &
OOT

9. This is a free preview copy of the original training “Analytical Quality By Design”
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