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SOP for GMP Inspections


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#1 robocik23

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Posted 24 November 2018 - 09:24 AM

Hello everyone,

 My name is Ewelina .

 

I have a question to ask , I currently was assign to write a SOP for GMP inspections - how to conduct a GMP inspection and

 GMP inspection - How to issue & close actions.

 

I know it is silly to ask as we all know how to do it , but writing this its the biggest struggle for me :helpplease:  :huh:

 

 

 

Thank you

Ewelina



#2 Ashfaq Hussain

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    Pest management and chemical handling.
    Operation and supply chain.

Posted 24 November 2018 - 10:48 AM

It will help you,

 

https://www.ema.euro...s-working-group



Thanked by 1 Member:

#3 Charles.C

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Posted 26 November 2018 - 11:57 AM

Hello everyone,

 My name is Ewelina .

 

I have a question to ask , I currently was assign to write a SOP for GMP inspections - how to conduct a GMP inspection and

 GMP inspection - How to issue & close actions.

 

I know it is silly to ask as we all know how to do it , but writing this its the biggest struggle for me :helpplease:  :huh:

 

 

 

Thank you

Ewelina

 

Hi Ewelina,

 

Is there a Product ?

is there a Process ?

Is there a specific FS Standard involved ?

 

Pls clarify a little.

 

PS - if you only require a generic SOP I suggest you study a web document like CFR Title 21, Part 110 which offers a basic set of GMP components.

https://www.accessda...cfm?CFRPart=110


Kind Regards,

 

Charles.C





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