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We are thinking of increasing the number of SOPs read per day from 10 - 15. 10 per day has been the practice by most companies now for many years. If we increse this what are the regulatory and industry views and expectations on this?
Is this a question for the GMP Commiittee? it is a strange question. Where is the evidence that industry expects 10 SOPs to be read a day? Surely the SOP training is based upon what the person needs to know to be able to discharge their duties. They only need the SOPs that are required for their job description. There should be a training curricular for each job and the person should work through that diligently and before commencing any of the tasks that require the SOPs.
Are you saying that each employee must read 10 SOPs a day? Surely not, since that level of reading would result in mindless scanning and you would get almost no work done!
Or, do you mean that the content of 10 SOPs is reviewed by someone each day? Even then, the frequency of review should depend on managements decision as to how often is relevant. This will depend on factors such as how stable the procedure is and how long established is the SOP.
And how many SOPs do you have? A small company might only have 10!
In summary, there are no rules for this under GLP except that management must decide and document the requirement (maybe in a SOP?!)
Thank you for the replies; we are a CMO, let me clarify the question - strange as it may seem; our SOP currently states we should read a maximum of 10 Sops per day. We have approx 600 SOPS and upon start any new manufacturing operator may be required by curriculum to read up to one hundred SOPS prior to starting work on the floor. so to minimize the mindless reading the SOP, I guess, was writen in such a way as to allow only 10 SOPS to be read per day. Some SOPS are very long too. THe question I was asked was what is the idustry practice and expectations regarding the number. I know there is no regulatory spscific but by experince what dfo we expect? Maybe you are right and this should be addressed to the GMP committee
BARQA GLP Committee
This is definitely a question for the GMP Committee, and is already posted on the GMP Forum. The GMP Committee review the content on a regular basis.
Alan Pipe on behalf of the GMP Committee
There is no industry standard for this - it is really down to the individual to ensure they are taking in the information. It would certainly help if there were training effectiveness criteria such as questions to ensure understanding.
The only specific number per day we have come across is maximum of 12, but this is very informal and should not be taken too seriously.
According to guideline written No employee should perform tasks until they have not been trained to perform there is no specific number defined in guideline but should be logical and explanatory
As i understand from the authors question, author is asking the limit of maximum number of SOP's can undergo training per day. In case of new employee training If that is the case if we consider the self reading each SOP will take 1/2 an hour on an average. so 15 SOP per day is almost 8 hrs with out break and deviation. it is not possible.
case 2 is class room training, in that case there may be some deviations from the schedule of the training and discussion may happen , doubt clarity may happen and 15 SOP per day is not possible.
Hope this answer clarified your question.