3 replies to this topic

[Angus86]

What are others procedures when it comes to approving SOP's and other documentation? Is it common to have approval signatures on each SOP? We do not have digital signatures, rather small company. If signatures are recommended, which personnel? We have Director or R&D, Product Compliance Manager, QC Manager and Production Manager. 

 

Thank you for an information!!!! 

[Charles.C]

It probably doesn't matter too much but is there any specific FS standard involved ?

[Angus86]

We are in ingredient product development and small scale production, so CFR 110. Most recently though, we've been venturing into supplements and I'm getting everything in compliance with CFR 111. 

[Charles.C]

Hi svnh.bell,

 

I assume yr query related to Procedures. Records, eg monitoring forms, might be different.

 

I’m not directly familiar with the detailed content of the cfr regs you are responding to but I can offer a generic answer to yr query. If there are any specific requirements in the cfr documents, those will supercede.

 

AFAIK there is usually no mandatory format for Procedures other than that which is acceptable to the Company / specified by Regulatory/Standard requirements. However  some typical styles do exist, eg ISO-related structures. There are many examples of such on this forum. Most (maybe all) include a “sign-off” box somewhere, sometimes >1.

 

IMEX the person who signs off for “Procedures” is typically the person who is authorised by the Company to have executive  responsibility for maintaining / acting upon the content of the relevant document.

 

Within the above numerous variations can be seen, eg  –

 

(a) Some Companies require 2 sigs on the Procedure such as by adding the (“higher”) authoriser of the first sig. as a “Verification”. This is usually  a formatting/Company Policy decision.

(b) Some Companies require the additional signature of  the responsible for a section where an associated  function, eg Engineering, is strongly involved.

(c) Some Companies allow the designated “responsible” person to delegate the sign-off to a nominated associate as per an agreed Procedure. This is anyway necessary in relation to back-ups.

 

As a (very) simple example, HACCP related Procedures such as monitoring / corrective actions are typically (but not exclusively) drafted and implemented by the QA Mngr who delegates various activities related to the Procedure, eg monitoring,  to QA Operatives. So the QA Mngr signs-off the Procedure.

 

Hope the above helps. Perhaps you have some specific Procedures in mind ?

 

Anyone who is familiar with cfr 110,11 only too welcome to expand/correct the above.