Bioequivalence and Bioavailability Forum

Dear esreddy!

❝ What is teh major difference between a Work instruction and a SOP.

GCP
ICH-GCP (Section 1.55):
'Detailed, written instructions to achieve uniformity of the performance of a specific function.'
WHO (Glossary to TRS 937/Annex 9):
'Standard, detailed, written instructions for the management of clinical trials. They provide a general framework enabling the efficient implementation and performance of all the functions and activities for a particular trial as described in this document.'

GLP
OECD (Section 2):
'Standard Operating Procedures (SOPs) means documented procedures which describe how to perform tests or activities normally not specified in detail in study plans or test guidelines.'

A work instruction should only be used in the development phase of a particular method; once a method is established, an SOP should be laid down.
Two points are of importance:

• If you don't have an SOP for a method, the performance must be described in detail in the study protocol.
  
• The study protocol may overrule any SOP; if you have to deal with a special case (which is not covered in the SOP) you may lay down the planned method in the protocol. IMHO it does not make sense to write an SOP for a procedure you will follow only once.

❝ Can we use both SOP and work instuction for one task.

This should avoided! Generally a work instruction is not included in the 'chain of command' (=the QA system of version control, approvals, etc.) and should lead to an SOP as soon as possible.