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Hi all,
I find that I overthink things, so this may be another example. I am wondering if I need to document the template/format of my procedures and work instructions. We have good formats that work, and we base future SOPs and WIs on existing, to keep the same format. However, this isn't documented. Should it be? I don't want to lose the template requirements, but I don't want overkill.
Also, another reason for my question is that my company used to be GMP certified. They had a procedure that covered the procedure format. Here is a clip from it:
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Each SOP will have a “header” which contains the following information:
Logo Block: As referenced above in this SOP, each SOP will contain a Logo Block that includes the logo and the generic title of “Standard Operating Procedures”.
SOP Title: Each SOP is identified with a brief description of the subject matter.
SOP No: Each major SOP is identified with an SOP number, which compliments the SOP title. The SOP number is intended to simplify the referencing of SOPs to improve communication throughout the corporate involvement of implementing these procedures.
Each SOP will have a statement for the listed elements, and be preceded by a number character.
1.0 Purpose and Scope: Describes SOP need and applicability.
2.0 Policy: Describes policy in regard to the SOP.
3.0 Definitions: Explains acronyms and specific terms used within SOP.
4.0 Responsibility: List responsible parties for implementing SOP.
5.0 Procedure: Describes processes to be followed and personnel responsible for ensuring that the process is followed.
6.0 Related Documents: References the documents or procedures that will be used in conjunction with the procedure.
7.0 History: Itemizes major changes in an SOP in a chronological format (time from initial SOP issue).
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My SOPs follow the nice format listed above, but I have archived the old GMP SOP. I am wondering if I need to re-issue it.
Comments?
Thanks!!!
I find that I overthink things, so this may be another example. I am wondering if I need to document the template/format of my procedures and work instructions. We have good formats that work, and we base future SOPs and WIs on existing, to keep the same format. However, this isn't documented. Should it be? I don't want to lose the template requirements, but I don't want overkill.
Also, another reason for my question is that my company used to be GMP certified. They had a procedure that covered the procedure format. Here is a clip from it:
--------------------------------------------------------
Each SOP will have a “header” which contains the following information:
Logo Block: As referenced above in this SOP, each SOP will contain a Logo Block that includes the logo and the generic title of “Standard Operating Procedures”.
SOP Title: Each SOP is identified with a brief description of the subject matter.
SOP No: Each major SOP is identified with an SOP number, which compliments the SOP title. The SOP number is intended to simplify the referencing of SOPs to improve communication throughout the corporate involvement of implementing these procedures.
Each SOP will have a statement for the listed elements, and be preceded by a number character.
1.0 Purpose and Scope: Describes SOP need and applicability.
2.0 Policy: Describes policy in regard to the SOP.
3.0 Definitions: Explains acronyms and specific terms used within SOP.
4.0 Responsibility: List responsible parties for implementing SOP.
5.0 Procedure: Describes processes to be followed and personnel responsible for ensuring that the process is followed.
6.0 Related Documents: References the documents or procedures that will be used in conjunction with the procedure.
7.0 History: Itemizes major changes in an SOP in a chronological format (time from initial SOP issue).
--------------------------------------------------------------------
My SOPs follow the nice format listed above, but I have archived the old GMP SOP. I am wondering if I need to re-issue it.
Comments?
Thanks!!!