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SOP SOS - Concerning a chemist process for pharmaceutical uses


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#1 nath10

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Posted 11 July 2011 - 01:39 PM

Hello,

I need to write SOPs concerning a chemist process for pharmaceutical uses.

I have a list of documents to fill: quality manual, deviation & CAPA and else…

I have some template of those files but in fact I have no idea how to “eat” the SOPs.

A member can help me in the redaction or send me a link to accomplish this task more concretely?

Thanks an advance

N.A.



#2 Charles.C

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Posted 14 July 2011 - 12:52 AM

Dear nath10,

Welcome to the forum! :welcome:

Yr request is a little unclear. :smile:

Are you asking for advice on the general method of writing an SOP ? (the details will depend on the specific product/process of course)

Rgds / Charles.C


Kind Regards,

 

Charles.C


#3 nath10

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Posted 14 July 2011 - 08:12 AM

Hello Charles.

I will start with SOPs in general.

Take for example a tea preparation ( sorry for tea expert): :drunk:



warm water at T= 60 C.

  • Poor 300 ml in a cup.
  • 3. Immerge the tea bag.

    4. Wait 30 sec.

    5. Remove the tea bag.

    6. Add sugar (spoon).

    7. Mix 2 sec.

    8. Analysis : An Y.<BR style="mso-special-character: line-break"><BR style="mso-special-character: line-break">

    how I build the SOPs map around this simple process?
    The content and the scope of each Sops? How I limit/enlarge the scope of each of it?
    The semantic is also important: key word used ?

    I know that it's a huge subject.
    So thanks an advance.

    NB




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