Imagine - Creating Healthy Workplaces - Anthony Montgomery.pdf
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Training Session on Good Manufacturing Practices of the 21st Century
1. GMP Intent & Cases
(Part 1/4)
Training Session by
OR Centre for Quality Sciences
Obaid Ali & Roohi B. Obaid
Good Manufacturing Practices (GMP) of the 21st Century
04 April 2021, Hotel Marriott Karachi
4. It reflects the views and
understanding of presenter &
may not be construed to
represent the views or
policies of organization or
association to which speaker
has ties
Documents of US-FDA,
Review Scientific Articles
are used to construct
presentation
Disclaimer Reference
18. • Some employee had not been properly trained
• Records were not adequately secured
• Established testing procedures were not being
followed
• Measures intended to prevent contamination or
mix up was found to be deficient
April 2020
19. • Astra Zeneca ingredients
• Spoiled enough raw vaccine up to 15 million
doses
April 2021
Recently mix up/contaminated
26. You have a batch of one drug. Samples of drug from the
same batch are picked for testing. It qualifies all attributes
upon testing. Testing was done by third party.
Can the same be safely used?
Yes
No
49. GMP Assures
Identity, quality & strength of drugs
Correct procedures are followed
Timely documented
Reviewed before release
50. Quality cannot be observed by every one and/or by naked eye
Quality cannot be tested in a laboratory but has to be built in to the product
We know
We know
51. If a drug is manufactured in GMP
environment & qualifies all tests, is it
sufficient for quality or something
remains?
59. Good Manufacturing Practices (GMP)
of the 21st Century
To transform pharmaceutical manufacturing
we have to identify inherent misconceptions and
improve ability to understand science