GMP SOP: SOP approval = SOP training?

GOOD MANUFACTURING PRACTICE (cGMP)
1

Hi! I have a quick question if anyone can help me. When a new SOP is effective, the department that uses the SOP needs to be trained by either reading the SOP, through hands-on training or attending a group training, etc.
My question is: do the people who approved the new SOP need to show proof of training for the new SOP? For example, if all the manufacturing SOPs are approved by the production manager, does the production manager need show proof of training when the SOP is effective, even though he is the one who approved it?

I hope my question makes sense.

Thanks!

2

The answer is yes. There should be a ‘training’ SOP that requires a document that people have signed and dated that particular SOP and understand it. The effective date should be 30 days after it is signed, thus providing time for people to be trained.

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3

thanks for the reply! So, does that mean even the person who approved the SOP needs to be trained?

4

Yes. His or her name should be on the form unless they have no direct interaction like testing the quality of a lot.

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5

Great! That answers my question! Thanks for your help.

6

There is no need of training of all those who involved in preparing, reviewing, approval of documents because names of concern persons reflected on documents and those all are subject matter expert in that particular activities. Another thing, after completion of 100% training of targeted audience SOP should be made effective. And at least after six months, training shall be checked effectiveness of training and all should be documented as evidence.

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7

I agree with abhjeet, because prepare by, reviwer, approver must be aware with the SOP content only after the can complete their job. Also the change in sop is proceed through change contol procedure where we take the review comment and signature of relavent individuals, mostly reviewer and approvers are covered in change control. Hence while he aaproved the change , he is well aware with revised content.

Training is required to aware the people for changes or updation in the SOP or document. This procedure alredy completed for prepared by, reviwer & approver during change procedure. So training not required for this people on implimetation of SOP or document.

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8

Yes, time bounding is must to complete training activities before implement the change.

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9

Thank you abhijeetghongade5 and nil_upadhyay. That makes a lot of sense. Having someone who developed the procedure and wrote the SOP show proof of training felt unnecessary.