2 oaro-interactive discusion-04 feb 2017
TRANSCRIPT
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Pharmaceutical MicrobiologyMultidisciplinary Integrated Approach in Drug Manufacturing
Obaid Ali & Roohi B. ObaidCivil Service Officers, Government of Pakistan
(2/5) Interactive Discussion
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Qualification of Disinfection1
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It is required for which Grade Room?
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It is required for which Grade Room?
A B C D
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It is required for which Grade Room?
A B C D
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Why disinfection for Grade A & B
Decontamination
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Why disinfection for Grade A & B
Decontamination Based on Risk Assessment
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Why disinfection for Grade A & B
Decontamination Based on Risk Assessment
Effectiveness to reach 2 log reduction for spores
3 log reduction for vegetative/fungi on sample surface
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Why disinfection for Grade A & B
Decontamination Based on Risk Assessment
Compatibility of disinfectant with the surface
Suitability & Safety of handling
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Why disinfection for Grade A & B
Decontamination Based on Risk Assessment
Efficacy & Reproducibility of the application procedure
Potential residue of disinfectant
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Why disinfection for Grade A & B
Decontamination Based on Risk Assessment
Be careful while studying surface characteristics & exposure time
Do not rely: Prove via study on actual surface with actual process
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Disinfection effectiveness is a continuous process
Maximum time between disinfection
More intensive EM
sampling
Pre-requisite of Initial
Qualification
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Sterilization of Disinfectants2
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Sterilization of Disinfectant/Cleaning Agent is nothing
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Sterilization of Disinfectant/Cleaning Agent is nothing
Yes No
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Sterilization of Disinfectant/Cleaning Agent is nothing
Yes No
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Sterilization of Disinfectant/Cleaning Agent is nothing
Need to be filtered with 0.2 u
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Sterilization of Disinfectant/Cleaning Agent is nothing
Need to be filtered with 0.2 u Filtration should be in a Controlled Environment
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Sterilization of Disinfectant/Cleaning Agent is nothing
Need to be filtered with 0.2 u
In a Sterilized Container
Filtration should be in a Controlled Environment
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Sterilization of Disinfectant/Cleaning Agent is nothing
Need to be filtered with 0.2 u
In a Sterilized Container Integrity of the Filter should be tested after use
Filtration should be in a Controlled Environment
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Sterilization of Disinfectant/Cleaning Agent is nothing
Need to be filtered with 0.2 u
In a Sterilized Container Integrity of the Filter should be tested after use
After filtration maintain Environmental Conditions of storage during studied life
Filtration should be in a Controlled Environment
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Sterility Test is required for Disinfectant/Cleaning Agent
Yes No
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Sterility Test is required for Disinfectant/Cleaning Agent
Yes No
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Sterility Assurance Level/Program3
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Environmental Monitoring is Element of Sterility Assurance Program
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Environmental Monitoring is Element of Sterility Assurance Program
Critical Major Minor
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Environmental Monitoring is Element of Sterility Assurance Program
Critical Major Minor
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If EM results cross Action Level do you think risk of product safety is under question
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If EM results cross Action Level do you think risk of product safety is under question
Yes No
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If EM results cross Action Level do you think risk of product safety is under question
Yes No
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Do you think product qualified for Sterility Test & manufactured in this area needs to be assessed for safety
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Do you think product qualified for Sterility Test & manufactured in this area needs to be assessed for safety
Yes No
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Do you think product qualified for Sterility Test & manufactured in this area needs to be assessed for safety
Yes No
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Do you think other products manufactured in these suspected dates need to be assessed for safety
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Do you think other products manufactured in these suspected dates need to be assessed for safety
Yes No
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Do you think other products manufactured in these suspected dates need to be assessed for safety
Yes No
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How would you quantify the effectiveness of any CAPA Program. Please make a list
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How would you quantify the effectiveness of any CAPA Program. Please make a list
Just review with great care previous CAPA on
the same issue
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What would be the procedure for media fill of terminal sterilized product?
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Media Fill for Terminal Sterilization Process
Media fills are NOT required for
terminally sterilized process.
If it will be performed it will fail
Absolutely unreasonable to
perform media fill
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Does any situation exist where aseptic manufacturing facility is allowed for manufacturing operations without qualification of air
flow pattern neither in static nor in dynamic conditions?
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Does any situation exist where aseptic manufacturing facility is allowed for manufacturing operations without qualification of air
flow pattern neither in static nor in dynamic conditions?
NOwithout evaluating
smoke study pattern in your critical area
If it is, it’s a big question on safety
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Lets fight with Logic and Balance it
Inspector’s ObservationZero Microbiological Testing of IPA
used as Disinfectant
Lets share your thoughts
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Lets fight with Logic and Balance it
Ideal paradigm is where there
is no contamination
Will it ever be possible ???
What’s the difference between viable and non-recoverable organisms?
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Lets fight with Logic and Balance it
Can someone be sure that things are in control?
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Lets fight with Logic and Balance it
Testing of IPA for bioburden certainly
provides more information about
control