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.

Dear esreddy,

The difference between SOP and Working Instruction is

SOP must be in passive voice.
WI must be in active voice.

and we can use SOP or WI for same purpose but after approved by QA

Keep in touch

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Edit: Capitals changed to bold (see the Forum's Policy) [HS]