Pharmaceutical MicrobiologyMultidisciplinary Integrated Approach in Drug Manufacturing

Obaid Ali & Roohi B. ObaidCivil Service Officers, Government of Pakistan

(2/5) Interactive Discussion

Qualification of Disinfection1

It is required for which Grade Room?

It is required for which Grade Room?

A B C D

It is required for which Grade Room?

A B C D

Why disinfection for Grade A & B

Decontamination

Why disinfection for Grade A & B

Decontamination Based on Risk Assessment

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

Why disinfection for Grade A & B

Decontamination Based on Risk Assessment

Compatibility of disinfectant with the surface

Suitability & Safety of handling

Why disinfection for Grade A & B

Decontamination Based on Risk Assessment

Efficacy & Reproducibility of the application procedure

Potential residue of disinfectant

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

Disinfection effectiveness is a continuous process

Maximum time between disinfection

More intensive EM

sampling

Pre-requisite of Initial

Qualification

Sterilization of Disinfectants2

Sterilization of Disinfectant/Cleaning Agent is nothing

Sterilization of Disinfectant/Cleaning Agent is nothing

Yes No

Sterilization of Disinfectant/Cleaning Agent is nothing

Yes No

Sterilization of Disinfectant/Cleaning Agent is nothing

Need to be filtered with 0.2 u

Sterilization of Disinfectant/Cleaning Agent is nothing

Need to be filtered with 0.2 u Filtration should be in a Controlled Environment

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

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

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

Sterility Test is required for Disinfectant/Cleaning Agent

Yes No

Sterility Test is required for Disinfectant/Cleaning Agent

Yes No

Sterility Assurance Level/Program3

Environmental Monitoring is Element of Sterility Assurance Program

Environmental Monitoring is Element of Sterility Assurance Program

Critical Major Minor

Environmental Monitoring is Element of Sterility Assurance Program

Critical Major Minor

If EM results cross Action Level do you think risk of product safety is under question

If EM results cross Action Level do you think risk of product safety is under question

Yes No

If EM results cross Action Level do you think risk of product safety is under question

Yes No

Do you think product qualified for Sterility Test & manufactured in this area needs to be assessed for safety

Do you think product qualified for Sterility Test & manufactured in this area needs to be assessed for safety

Yes No

Do you think product qualified for Sterility Test & manufactured in this area needs to be assessed for safety

Yes No

Do you think other products manufactured in these suspected dates need to be assessed for safety

Do you think other products manufactured in these suspected dates need to be assessed for safety

Yes No

Do you think other products manufactured in these suspected dates need to be assessed for safety

Yes No

How would you quantify the effectiveness of any CAPA Program. Please make a list

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

What would be the procedure for media fill of terminal sterilized product?

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

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?

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

Lets fight with Logic and Balance it

Inspector’s ObservationZero Microbiological Testing of IPA

used as Disinfectant

Lets share your thoughts

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?

Lets fight with Logic and Balance it

Can someone be sure that things are in control?

Lets fight with Logic and Balance it

Testing of IPA for bioburden certainly

provides more information about

control