Hi all, have just been tasked with creating multiple SOPs and WIs for my company. Was wondering if anyone out there has any handy information or tips that would make things easier lol.
Don’t reinvent the wheel, take an existing procedure and use as a template. Keep any common instructions or information the same across them all and go from there. If it’s a procedure for a process, images are king. Clear and concise images are a whole lot better than words!
Yeah, this. I've never done SOPs, but I've done a number of WIs. It's always better to start from an existing one as a template; it gives everything cohesion.
I'm sorry, if one needs to ask on Reddit about how to create SOP/WI - why are you tasked to do this? Clearly you are not the right person to perform this task? And SOP/WI is incredibly important that impacts everyone in the company - I would rather there is no SOP/WI than some shitty made up SoP/WI (that make people life harder).
Seriously this shows so much farce behind the scene of the pharmas, is this a local/small pharma? It would be scarier if this is medium/big pharmas lol (won't be surprised).
I’m in a big pharma company and it’s common here, at least within my dept. The more junior staff get stuck with doing this stuff because it’s difficult and more senior members can’t be fucked and make it someone else’s problem.
That being said, any new documents (especially GMP ones) will go through a pretty rigorous review from any affected departments before they go live.
Lol yes that's the 'problem' but some cunts could do what they want - and the juniors won't have any idea what's supposed to or not to, and the cycle continues forever this way.
Rigorous review you say? Me and you know that is also very likely not true if the company let juniors draft their SOP/WI - their SOP/WI are likely very bloated and overlapping themselves - any newcomer wil get to experience that lolol. Supposedly they should have annual review/revision of these SOPs but ya we all know don't touch it unless there is problem - but in fact many info in these SOPs are outdated and should have been removed/revised but nobody gives a damn.
Can’t speak for most pharma, but at least in my current place I know they can get torn to shreds during the review cycle. Now, there’s still a problem with this - people reviewing will tell you somethings wrong and needs to be fixed, but often give little guidance on how to resolve and it gets dumped right back onto the more junior colleague to figure out.
My current place is a typically 3 year periodic review cycle - same with my old company - but like you said, some documents get updated more frequently when incorrect or outdated info is found. It’s not a good process by any means. Realistically most places do not have the resources to review all documents yearly and to make sure it’s done properly.
But there is a problem with review cycles in general. If you’ve ever done a technical writing course you’ll know how in depth they say you should go with every review of a document - but most people are stretched thin in pharma and don’t have the time to do it properly.
I was going to say more commonly they review every 2-3 years yes.
And oh no the entire topic triggered my reactions because yes I deal with site/technical documents all the time, and I have the pleasure to review and make sure the shit is fixed in the documents as these files are scrutinized in regulatory compliance. I don't really give a damn to SOP/WI but the principle applies on how we should manage and control the files in a (supposedly) GMP environment.
The job became very hard whenever I joined a new company/dealt with a new client - they want to fly but most of these basic shit are not in place that they can't even walk properly. And of course in order to deliver I have to fix some (not all, of course) and manage work through the crap, and I can't even complain or help them to fix the core issues (I tried, and it is not worth it for the effort and most likely these people take it personally/very immature about it).
And 'stretching thin' cannot be a reason when you get audited. Yes we all know we are understaffed/underpaid, but say something and make the management aware. It is increasingly tiring for the farce in the industry - I joined 9 companies in my 15 years career and I have worked with more than 100 companies/CMOs at this stage, shit gets so tiring.
People like you are exactly the core problem of the industry - just because you did it (you didn't know better back then), doesn't mean the crap should have been done the same way as you did - you now have your (stupid) agenda and ego so you won't admit that it shouldn't have been done by people who clearly don't have a clues about the task/topic.
We are in science, we are supposed to do better (GMP continuous improvement anyone?) and progress better, for the patients and humanity.
Lol sorry this is nothing personal at all - I was a junior who tasked to draft a SOP/WI (and no stringent review process lol) but in fairness it was a new acquisition with the processes I came out with, so that makes sense.
So ya my man/woman, at least you learnt that creating SOP/WI is not something to be taken lightly and it impacts absolutely everyone - so you need to be very smart, 'agile' and make sure you keep alot of flexibility in them (so try to not include some really detailed info/steps in it that others may have their own ways to perform such processes).
You are definitely not supposed to do this task, but hey you can't say no but at least you have better awareness what's going on (and don't say nobody told you this lol).
I'm just so so tired of fixing so much shit every project/every company I joined/every client company I dealt with....
Don’t reinvent the wheel, take an existing procedure and use as a template. Keep any common instructions or information the same across them all and go from there. If it’s a procedure for a process, images are king. Clear and concise images are a whole lot better than words!
Yeah, this. I've never done SOPs, but I've done a number of WIs. It's always better to start from an existing one as a template; it gives everything cohesion.
This is good advice. Would also suggest reaching out to and setting up times with SMEs if needed!
I'm sorry, if one needs to ask on Reddit about how to create SOP/WI - why are you tasked to do this? Clearly you are not the right person to perform this task? And SOP/WI is incredibly important that impacts everyone in the company - I would rather there is no SOP/WI than some shitty made up SoP/WI (that make people life harder).
Seriously this shows so much farce behind the scene of the pharmas, is this a local/small pharma? It would be scarier if this is medium/big pharmas lol (won't be surprised).
I’m in a big pharma company and it’s common here, at least within my dept. The more junior staff get stuck with doing this stuff because it’s difficult and more senior members can’t be fucked and make it someone else’s problem.
That being said, any new documents (especially GMP ones) will go through a pretty rigorous review from any affected departments before they go live.
Lol yes that's the 'problem' but some cunts could do what they want - and the juniors won't have any idea what's supposed to or not to, and the cycle continues forever this way.
Rigorous review you say? Me and you know that is also very likely not true if the company let juniors draft their SOP/WI - their SOP/WI are likely very bloated and overlapping themselves - any newcomer wil get to experience that lolol. Supposedly they should have annual review/revision of these SOPs but ya we all know don't touch it unless there is problem - but in fact many info in these SOPs are outdated and should have been removed/revised but nobody gives a damn.
Can’t speak for most pharma, but at least in my current place I know they can get torn to shreds during the review cycle. Now, there’s still a problem with this - people reviewing will tell you somethings wrong and needs to be fixed, but often give little guidance on how to resolve and it gets dumped right back onto the more junior colleague to figure out.
My current place is a typically 3 year periodic review cycle - same with my old company - but like you said, some documents get updated more frequently when incorrect or outdated info is found. It’s not a good process by any means. Realistically most places do not have the resources to review all documents yearly and to make sure it’s done properly.
But there is a problem with review cycles in general. If you’ve ever done a technical writing course you’ll know how in depth they say you should go with every review of a document - but most people are stretched thin in pharma and don’t have the time to do it properly.
I was going to say more commonly they review every 2-3 years yes.
And oh no the entire topic triggered my reactions because yes I deal with site/technical documents all the time, and I have the pleasure to review and make sure the shit is fixed in the documents as these files are scrutinized in regulatory compliance. I don't really give a damn to SOP/WI but the principle applies on how we should manage and control the files in a (supposedly) GMP environment.
The job became very hard whenever I joined a new company/dealt with a new client - they want to fly but most of these basic shit are not in place that they can't even walk properly. And of course in order to deliver I have to fix some (not all, of course) and manage work through the crap, and I can't even complain or help them to fix the core issues (I tried, and it is not worth it for the effort and most likely these people take it personally/very immature about it).
And 'stretching thin' cannot be a reason when you get audited. Yes we all know we are understaffed/underpaid, but say something and make the management aware. It is increasingly tiring for the farce in the industry - I joined 9 companies in my 15 years career and I have worked with more than 100 companies/CMOs at this stage, shit gets so tiring.
:’(
Don’t listen to this clown.
Eh you started this ad hominem first.
People like you are exactly the core problem of the industry - just because you did it (you didn't know better back then), doesn't mean the crap should have been done the same way as you did - you now have your (stupid) agenda and ego so you won't admit that it shouldn't have been done by people who clearly don't have a clues about the task/topic.
We are in science, we are supposed to do better (GMP continuous improvement anyone?) and progress better, for the patients and humanity.
Lol sorry this is nothing personal at all - I was a junior who tasked to draft a SOP/WI (and no stringent review process lol) but in fairness it was a new acquisition with the processes I came out with, so that makes sense.
So ya my man/woman, at least you learnt that creating SOP/WI is not something to be taken lightly and it impacts absolutely everyone - so you need to be very smart, 'agile' and make sure you keep alot of flexibility in them (so try to not include some really detailed info/steps in it that others may have their own ways to perform such processes).
You are definitely not supposed to do this task, but hey you can't say no but at least you have better awareness what's going on (and don't say nobody told you this lol).
I'm just so so tired of fixing so much shit every project/every company I joined/every client company I dealt with....