Posting: # 1141
What is teh major difference between a Work instruction and a SOP. Can we use both SOP and work instuction for one task.
Posting: # 1143
» What is teh major difference between a Work instruction and a SOP.
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.'
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:
» 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.
All the best,
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Posting: # 1179
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
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Edit: Capitals changed to bold (see the Forum's Policy) [HS]