[Music] welcome to the qualitox podcaster show about farmway GMP I'm Ian Google your host and today my guest is Nathan Roman the director of validation at Genesis AAC continuing our podcast series Nathan is a passionate about thermal validation and loves helping people learn how to implement and Carry Out temperature mapping studies and Equipment qualifications today's podcast will cover all you need to know about creating good qualification protocols I want to thank yupri a leading temperature compliance service with the most Innovative and stable Solution on the market for sponsoring this podcast episode hi Nathan it's great to have you back for our series about temperature monitoring today we will discuss the essentials of qualification Protocols are you ready to begin hey yawn it's great to be back yes I'm absolutely ready great to ease into it let's start with an introductor question that should help industry newcomers what is a qualification protocol and why it's so important to get it right that's a really great question John the definition of a protocol is a written plan describing the process to be qualified and how the qualification is to be conducted um it's the the protocol is necessary to define the specific items and activities that will um constitute um the proper tests that you plan to conduct for for your equipment or systems a properly developed qualification protocol will help ensure that the equipment meets all the documented requirements and um proves that the equipment performs as expected so Nathan where do you start when preparing the qualification protocol and what do you need to consider beforehand I think the first step to writing an effective protocol is to understand the project and its requirements another step would be to have templates or a basic format for protocols for iqoqpq protocols help to assure the consistency in the documentation document prep but to achieve the first step of writing effective protocols I created a prereq form a prerequisites form that form helps in a way to better understand the project and a way to make protocol generation more effective more efficient because we all know that when trying to generate a document or even when executing a document those unfulfilled prerequisites are a major cause of down times and wasted dollars so the prerequisite form enables us to cut down costs and essentially to deliver a thorough protocol can you give us some examples of what a good qualification protocols might include sure absolutely once once the customer would complete the prereq form and send it back to you um then you'd have the information you need to begin preparing the document information such as you know the their contact info who's the primary point of contact for this validation protocol um you know identifying the roles for the protocol review and approval as you know we need to review and approve these documents and and that sign off sheet or if it's an electronic documentation Management program those um those approvers and reviewers and approvers are required to know General equipment information about the equipment or system ID manufacturer model number serial number specific details about the equipment process range operating set points alarm set points Etc we'd be looking for calibration information calibration status Cal date due date um documentation of previous validation status prior qualification numbers Sops change controls um that's you know um facilitating the this disqualification whether it's a new or existing or a re-qualification and any supporting documentation that is pertinent to this document development such as manuals templates user guides and any type of specs um but yeah so that's that's the types of things that would go into a qualification protocol um obviously the uh the operational tests and test scripts that that um you know provide information on on how the op how the unit operates how the equipment functions um how it's how it's to perform or expected to perform what would you say are some of the most common problems at different stages of the qualification protocol that you typically encounter some of the common problems that I see when executing or even developing qualification protocols uh or like we had mentioned earlier unfulfilled uh prerequisites not having the information that you need to fill out the document can can really hold up the review and approval process let alone even get to the execution um so not having the information in a timely fashion or at all not even knowing what to ask for um to to help you develop your document that's that's an issue that can be resolved um provided you have that information requested up front the the other issue that I see is good documentation practices uh in the old days GDP but now that's not referenced as it's gdps so much but good documentation practices um and I think that's a training issue um so you know um folks that that need to to learn GDP to to understand um initialed and initial and dates verified by reviewed by um understandings the significant figures um uh understanding a clear way to write comments in a protocol um so I think that GDP is is a common problem um unfortunately that that that exists when executing protocols um but again that that can be taken care of with some training um the another common problem is the approach to attachments in in labeling the attachments lots of folks don't have a firm grasp of attaching these protocols or attaching the um the the the spec sheets manuals drawings um you know um printouts things like that to the protocol um properly they they sometimes they they just attach it they just you know put it at the end of the binder but you know is there an attachment log is there are these attachments labeled properly um you know and if something would fall out of the document would you know where it goes and what it belongs to let alone what document so some of those um would be common problems that that I that I definitely see out there before we continue to the next question let me thank you again for sponsoring this event if you want to upgrade your data loggers you should know that you produce wireless temperature Data Logger constantly sends data to web-based software via Wi-Fi it provides real-time temperature reports of your refrigerator freezer storage area etc for ultimate compliance one temperature deviation happens it will immediately send you an SMS and email alarm which minimizes the risk during the monitoring process so make sure to visit them at upre.com it's eupry.com later today how would you say that a qualification Protocols are changing with the introduction of new technologies so from my experience I see a lot of big consultancies trying to use Plug and Play Solutions so does it still work I hear you uh that's a that's a pretty good question actually um so I would have to say the qualification Protocols are changing with the introduction of new technologies in in different ways one being the introduction of you know the paperless validation and I know that's not a brand new thing it's been around for you know over a decade now but the concept or the um incorporation is is new starting um to be more um recognized and accepted so that's when I say that that's feeling like it's new because you know the traditional way of of executing protocols or or developing them is all paper based and you know you you develop the document you get approved and then you print it out and you go execute right but with the paperless everything's done online and you know you you walk around in with the tablet and you know you check a box instead of initial and date um you know ver you know those types of things so in that in that regard it's definitely changing um because um you know it's as far on my end of things so the Consulting side the cost to develop documents um goes down a tad because you you are no longer having to you know recreate documents from scratch or use a template to to write up a document because in those paperless validation applications you have a you know templates inside that system where you can you know quickly draw up um the the equipment or the system and and create a protocol for your specific instance um but you mentioned the Plug and Play solution so for those that may not quite know what that is um the the Plug and Play would be you know um the the vendor building their the equipment and testing it certifying it at their facility and delivering it to you and um you have the confidence that that testing um you know holds true and that you don't you don't need to perform testing you can just utilize your equipment you know similar to the the idea I guess of you know um off-site Construction and building a house where everything is is done um at their facility and they deliver a fully furnished you know functioning home for you um but I'm not so sure that in in our industry just yet that people are gonna buy off on those um Plug and Play ideas on some items it could I could see it um working out but um others we still have a little bit of a ways to go I think to to truly have confidence in um in that approach I know that a lot a lot of folks in the industry especially on the quality side want to see the testing done in-house a lot of things do change once the equipment is delivered install hooked up to networks hooked up to the in-house piping drainage um you know the ventilation airflow so there's a lot of different things that still would be required to be tested but um but I understand your question and and yeah it could certainly change things a bit but uh but I don't think that it's going to make that big of a impact just yet I bet that throughout your career you have seen some very bad protocols to have also some crazier funny stories to tell about it sure yeah over the years um a lot of protocols um I I guess what I can I can provide to you now is a story about uh I guess I'll just pick on myself for example um back early on in my career as a validation specialist um it I think it would fall under the the the the premise of um lack of experience or maybe training but early on executing a protocol for a piece of equipment and a clean space um I was trying to um just follow test scripts and you know like it starts out with power on the uh the piece of equipment and as I was attempting to do that the uh the the equipment was not powering on um it wasn't it wasn't turning on it wasn't functioning um you know so I was concerned that something was wrong with the piece of equipment and so I alerted the facilities manager and they took me at my word that the piece of equipment wasn't functioning it wasn't turning on it didn't have power so they took me at my word and they hired out a electrical engineer to come in and check out the system make sure you know that it that it wasn't um wasn't a problem was functioning properly well come to find out um the facilities manager later found me and told me that it was as simple of a problem as not being plugged in so you know that was that was kind of nuts um kind of goofy of myself to to to let happen I felt pretty darn embarrassed that I didn't even verify that the the piece of equipment was plugged in before I was trying to to actually execute any of the protocol test scripts so that's that's kind of silly um but since then have learned but another um crazy thing that I've found on a protocol was actually it was a document that I was reviewing for for a customer in it was a PQ for a piece of equipment and I'm not real sure what had happened but um the the document that I was reviewing was was ripped in half the approved document was ripped in half and taped back together and executed um so I'm not sure what happened there but that would be that would be a you know a no-go that would not be allowed um but but yeah so that was that was pretty crazy protocol being ripped in half and um and taped together and executed so pretty nuts if you ask me so Nathan do you have any good resources that you can recommend for people to learn more about the best practices of writing good qualification protocols or addressing issues during the measurements and when they encounter deviations for example I gotta be honest here that um I'm I'm not too sure where you can go to get um better resources to to learn about writing protocols um I I don't think that it it it exists really other than you know some some training that you might find online um around you know maybe some GDP maybe some you know GMP training but writing good protocols um it it I don't I'm not sure that that I can provide a reference or a resource but I do know that there are training platforms out there that do provide a lot of content and a lot of good information I'm definitely trying to put out information now about writing protocols about qualification what's in a protocol what's to ex to be expected um what the prerequisites are to write a document I'm I'm putting this kind of information out there because I I felt that there was a lack of it so now as as far as putting courses together things like that to help train people that has been something that has been weighing on my mind I've been talking to you know folks um over at Viva for example I have a friend over there and you know just talking about training courses and I think something like that is is lacking really in the industry for for folks for especially for the newcomers that are coming into the industry um having to put protocols together having to execute you know a lot of this stuff is is learned on the job and I think that um if you know if there was just a some free courses out there that can provide people a little bit of um training on writing executing what goes in the document what do you need to look for how to execute the document things like that would be truly beneficial great then so before we finalize our session today is there anything else that you would like to add something that we miss didn't talk about but you feel it's very important for the audience to know sure thank you yeah I guess one final note that that I'd just like to say is I know that to some folks out there validation and qualification might seem like a a long drawn out process sometimes and it's true commissioning qualification validation is filled with you know documents upon documents sometimes uh testing and and more testing um you know with many hours spent in the field or behind your desk but you know understanding how to be efficient in validation um you know discussing the things that we're discussing going over the topics yawn that that you're bringing to the table um is an integral step to to Quality Assurance to understanding quality and the many different aspects of compliance in the Life Sciences industry so you know with that I'd like to just leave us and say that you know the work that you are doing out there matters right helping life science organizations uh ensure the quality and safety uh when carrying out these commissioning qualification validation projects uh protocols writing protocols um inefficient manner you know It ultimately ultimately leads to saving lives you know so just wanted to put that out there and um and I really appreciate having me on the show and I look forward to doing it again as always thank you John great day then so thank you very much for another very insightful session I will say to you for will for now but we will meet soon for another session on the topic of a temperature mapping sounds great to me Jan thank you so much appreciate it thank you thanks for listening to the koala talks podcast if you enjoyed the show please leave us a five-star review if you want to learn more about GMP please visit us at www.qualistoread.com stay compliant and see you at the next one [Music]