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Creating a Sustainable Culture of Quality
Roohi B. Obaid
03 Aug 2019 (Part – I)
(10 Min)
Pre - Assessment
History & Prior Knowledge
Case Studies & Discussion on
Phenomena
Future & Emerging Map
Tutorial
Critical Thinking & connecting
the dots
Group Discussion
Use Reason
If you weigh and add correct
quantity of material
Do you think testing for
assay is required?
Use Reason
If you weigh and add correct
quantity of material
Do you think testing for
assay is required?
1
Tablet
Use Reason
If you weigh and add correct
quantity of material
Do you think testing for
assay is required?
2
IV Sol
Dextrose solution
Testing is an indicator of
quality insight
Group Discussion
Testing is sufficient
Testing is not sufficient
For
Quality
The drug which is tested, is not
given to patient
&
the drug which is given to patient
is not tested
Mistakes are not shared with bosses
Is it a Quality Culture?
Set the Tone of Quality Mode beyond the Compliance
Regulations
EnforcementCompliance
Guarantee
?
Recalls
Aripiprazole
(1 mg/ml oral solution)
Potential small particles of API
may alter the efficacy
30 July 2019
MHRA
Oxycodone
(5 mg oral tablet)
Mix up of a strip of morphine
tablet 30 mg was reported
30 July 2019
TGA
Drospirenone
3 mg & Ethinyl
Estradiol 0.02 mg
OOS in dissolution
results at 3 mo
stability point
23 July 2019
FDA
Safe, efficacious & have correct identity
Assume …
…. Drugs are
Deliver the same performance as claimed
Assume …
…. Drugs will
Perform consistently over shelf life
Assume …
…. Drugs will
Made in a manner that ensure quality
Assume …
…. Drugs are
be available when needed
Assume …
…. Drugs will
Thanks

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Culture of Quality - Part I (Updated & Reproduced) 03 Aug-2019