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presentation @ Patheon –
Pharmaceutical Culture of Quality, Bridgewater, NJ Seminar
In preparing the day long training session I had asked the following
questions
Prologue • How to effectively communicate to an audience of a group of young and bright Indian
professionals in any company in India and their supervisors/management about the
importance of cGMPs and QbD?
• How do I understand their challenges, perspectives and biases?
• How do I connect with them to share the joy of Quality by Design?
The response received has been overwhelming from the audiences in India
and yesterday at the Patheon Seminar in Bridgewater, NJ
• I hope you will also the see some of the important dots and the connections
• How this content connects to regulatory requirements is not covered in this slide deck – it
connects via ‘A, B, C, D’ to 21 CFR, Quality Systems Approach to cGMP, ICH 7, 8, 9, 10, and 11.
in Indian Generics
Manufacturing
Understanding the behaviors –
it is a human issue & this is not about India.
http://www.pharmamedtechbi.com/publications/the-gold-sheet/48/3/confronting-illusions-of-quality-in-indian-generics-manufacturing
Quality by
Design
Where do corporate
Irrationality, Biases, Thinking
managers, schooled in
Fast, and Slow – connections
rational assumptions ….go
to econometrics suggested.
from here?
Deming - The journey
requires leadership with
Profound Knowledge as
a guide. Is there a culture of error
When organizations
management where there’s a
acknowledge and anticipate
genuine effort to learn from
irrational behavior, they can
mistakes, or is it one of error
learn to offset it and avoid
aversion, where errors are
damaging results.
avoided at all cost?
Econometrics
Commercial operations,
Ajaz S. Hussain. SWISS profitability & availability
PHARMA 34 (2012) Nr. 6.
some degree.
Claims
Warrants
WL in 2013 + 31%
The chairman of the Reaction was swift. “To pin the blame on [a Nation’s] culture is the
Fukushima Nuclear ultimate cop-out,” Columbia University professor Gerald Curtis wrote in
Accident Commission the Financial Times. “If that is Japanese culture, then we are all
blamed the disaster on “the Japanese”.
ingrained conventions of “Is there a culture of error management - where there’s a genuine effort
Japanese culture”. to learn from mistakes, or is it one of error aversion, where errors are
avoided at all cost, people can expect to be metaphorically dragged out
in to the alley as a prelude to the evidence being covered up?”
http://mbs.edu/mbshub/Pages/Article/How_Fatal_is_your_firms_Error_culture.aspx
James Reason
Organization
(Policies & Sr.
Mgmt.)
Team & Supervisor
(Soft Defenses)
J. Reason. Human error:
models and management. Individual
Error (Training & Certification)
BMJ. Mar 18, 2000; 320: 768– Defenses
770 Technology (Quality Management System)
(Constraints & Controls)
An increasingly
From individual to
common pattern “…observed analyst
“…over-writing
electronic raw system failure –
back-date logbooks”
in recent FDA data…..” with each
additional
483’s observation,
“…results failing confirmation of a
specifications are system with
“…trial injections…..” retested until intentional ‘holes’
acceptable results
are obtained….” in its defenses.
compliance”.
Subjective Future
Past Intention
Behavior norm Behavior
level, in QC documentation
Process
function– how validation is done
so quality is
not critical;
attitude
occur? toward test prone to subjective Compendial
performing error norm testing sufficient
the behavior
Indian regulators
In general – low empowerment “Batch failure
collect & test
is a significant challenge (low means I made a
samples – no
mistake”
perceived behavioral control); issue there
reminder -
FDA inspectors look for • Certainly the companies are obligated to ensure a
Heparin tragedy a culture of quality at culture of quality and maintain vigilance as well.
(2007-2008) manufacturing facilities. This reflects a systems approach to safety.
When the drug safety This system approach • FDA policies led to the failure to inspect the
system fails, people get wasn't at play here. Chinese plant.
sick. Some die…
Congressman Shimkus
(Illinois) This brings me to China • While it doesn't deny the counterfeit source, tries
and its quality culture or to say that counterfeits didn't cause the reaction,
lack thereof. as if the adulteration itself was no big deal.
https://house.resource.org/110/org.c-span.205093-1.raw.txt
I • LABORATORY CONTROLS
Culture
Culture of Quality creates an environment needed to facilitate every
individual to guide his/her own behavior to work in the interest of
patients and to continually improve this ability.
How to System
Connect? A systems approach to quality is essential! It recognizes that the
weakest link in the system is often human fallibility – variable
capacity to act consciously – when no one is looking.
GXP, Behavior
An organization is a complex system which makes many thousands
of decisions each day – writing a SOP for each decision by each
individual (controlling behavior) is not always practical.
communicate IV
3
D
Z
(1) It is Normal to Do
Culture of
Quality Act consciously in
the interest of
Consciously – by design: (2) It is Rewarding
Scientific Methodology,
patients – (satisfaction)
Engineering Design, or specially when no
Plan-Do-Check-Act one is looking.
Interest of Patients:
Regulatory commitments +
(3) It is Easy to Do
A
Quality 1. Normal
Management Culture of
B
System Quality
2. Rewarding QMS
C
3. Easy
Any Body Can Dance
D
QMS to GXP
Behaviors
A
1 X
Facilitating error detection B
and correction. CoQ 2 QMS
GXP
Behaviors
Y
C
X
C. van Dyck. Putting errors 3
D
to good use : error
management culture in
organizations (2000).
http://dare.uva.nl/document/83803
A poor quality product is an error consequence and is not
necessarily related to error management per se. In fact, a poor
quality product may be the result of lack of error management.
Covering up
Z. Awareness
Communicating
C. van Dyck. Putting errors to Analyzing errors Anticipation
good use : error management Error correction Risk-taking
culture in organizations (2000). Learning from errors to
http://dare.uva.nl/document/83803
QbD/RFT
Error detection
Analyzing errors
Correction
Richard L. Friedman, M.S. Management Oversight and Lifecycle Quality Assurance. FDLI Workshop, Washington DC, 14-15 July, 2014
Effectively Behavior
Quality It is normal, easy and rewarding to work within our quality management
system, without fear, to detect, correct and to learn from errors.