SOP for GMP Inspections

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

It will help you,

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

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