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Nature of references allowed to be cited in the SOP

#1
what is the impact(acceptablity) of citing literature in the references section of SOP; ( viz., any industry-white paper or professional forum viz., ASQ or even elsmar )

is there a requirement / expectation which restricts/guides to cite only ones from regulatory authorities or regulatory recognized bodies?
 

John Broomfield

Staff member
Super Moderator
#2
References are open to interpretation. SOPs should not be. A documented procedure, instruction, form specifies the organization’s approved interpretation.

The system will help process owners to monitor changes to laws and regs that are relevant to the process in question and should cause the documented procedures to be updated so the process remains compliant.

The process owner will also be familiar with any relevant references as part of their competence.
 
#3
The system will help process owners to monitor changes to laws and regs that are relevant to the process in question and should cause the documented procedures to be updated so the process remains compliant.
hence by that definition, it is not 'appropriate' to cite an site viz., Elsmar -repository as an reference in SOP.;
because, it is not an standard but an compilation of industry practices if not best practices. ( i am referring to various files section of CAPA , or devices related files etc)
obviously, it is not a standard for which the process owner need to be updated or compliant with.

thank you for the clarification.
 
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