ISPE China PQLI RN.ppt

CHINA ANNUAL CONFERENCE
16th – 17th April 2012, Beijing
PQLI: Bringing QbD to Life
roger nosal
Vice President
Pfizer Global Chemistry, Manufacturing & Controls
Contents
ICH – QbD Concepts
PQLI – QbD Application & Implementation
Translating ICH Q8R/Q9/Q10/Q11 concepts to reality
Product Realization Guidelines
Application of QbD Principles
Can we achieve Global Harmonization through the application of QbD?
2
ICH Pharmaceutical Quality Vision
“ Develop a harmonised pharmaceutical quality system applicable across the lifecycle of the product emphasizing an integrated approach to quality risk management and science.”
Bruxelles July 2003
Industry’s Version of Vision
Globally harmonized regulatory acceptance of pharmaceutical development & manufacturing that provides
Improved quality assurance through increased product knowledge & process understanding
Regulatory flexibility to continuously improve throughout product lifecycle
3
ICH Guidelines
ICH Quality Guidelines (see ICH web site for latest versions)
Q8(R): Pharmaceutical Development
Q9: Quality Risk Management (QRM)
Q10: Pharmaceutical Quality System (PQS)
Q11: Development & Manufacture of Drug Substances
Quality Implementation Working Group (QIWG) on Q8, Q9 and Q10
Questions & Answers
Points to Consider
4
Union of ICH Q8, Q9, Q10 & Q11
/Q11
5
7
QbD = Process Understanding
A process is considered well understood from the physico-chemical perspective when
Key sources of variability are explained
Quality attributes can be predicted based on key inputs
Process capability of “Key Quality Attributes” meets acceptance criteria
“A well understood process is by definition a process with a low risk of delivering a poor quality product.”
J. Scott, ASTM, London 2004
8
People
Equipment
Measurement
Process
Materials
Environment
I
N
P
U
T
S
(X)
Process Understanding
y = ƒ(x)
OUTPUT
y
Inputs to the process
control variability
of the Output
Process Parameters
Quality Attributes
PQLI ® Vision