hello everyone and welcome to today's webinar analytical quality control for the pharmaceutical industry i am tracy aston martin of lab roots and i'll be your moderator for today's event today's educational web seminar is presented by lab roots and brought to you by sartorius to learn more about sartorius visit them online at sartorius.com let's get started i would like to remind everyone that this event is interactive we encourage you to participate by submitting as many questions as you want at any time you want during the presentation to do so simply type them into the ask a question box and click send we'll answer as many questions as we have time for at the end of the presentation also please notice you can share this webinar on your personal social media just click on the social sharing tab to let your friends and colleagues know about today's live event if you have trouble seeing or hearing the presentation click on the support tab found at the top right of the presentation window or report your problem by clicking on the ask a question box located on the far left of your screen this presentation is educational and thus offers continuing education credits please click on the continuing education credits tab located at the top right of the presentation window and follow the process to obtain your credits now present today's speaker joy mcilroy joy is the owner and consultant of mcilroy training and consultancy llc for a complete biography on our speaker please visit the biography tab at the top of your screen joy you may now begin your presentation thank you tracy thank you for that introduction and thank you all for attending our presentation today we'll go ahead and we'll get started we'll talking about analytical quality control we want to understand that analytical quality control is referring to the process of detecting any types of analytical errors that we have or that we may encounter within our laboratories we want to ensure that there is reliability and all and accuracy of our test results because we want to be sure that we are manufacturing and providing the best possible product to our customers we want to be sure that we do not have any types of unreliable performing instruments unreliable performance can result in of course us releasing adulterated product and of course this can be can be fatal to our potentially fatal to patients that are receiving the product so it is great important that we ensure that all of our results are provided um that are that we provide are very are absolute accurate and that they are reliable so this is why we are interested in quality analytical quality control and not just you know manufacturing quality control so how do we establish analytical quality control we established this through having written standard operating procedures as well we want to have sops for our analytical equipment we also want to have written methods uh our test methods for equipment for our procedures that we carry out on these instruments so sops our standard operating procedures are basically written instructions they are going to document a routine or a repetitive activity that we follow within our organizations we have sops in manufacturing for operating equipment and for performing different types of processes that is the same for our laboratories we want to have sops for operating our analytical instruments and for performing maintenance and calibrations on these instruments uh we also want to have them for uh and written test methods to follow the reason that we provide this documentation is to have that control everyone is trained on these documents everyone signs off that they have been trained some of uh organizations will have us to take a little quiz after we've read and trained on the sop to make sure that we understand it um and then everyone follows this sop to exactly as it is written sops address requirements that are there for us to perform jobs and also perform them safely to operate our instruments safely and correctly we have to understand that the sops will fail obviously if they're not followed so we want to make sure also as part of this control that we are reviewing sops on a regular basis so that we can add any new instructions take away something that is not needed making sure they're always accurate and also we need to make sure that management is enforcing the um these as the following of these sops we need to train our employees our analysts as they come in the importance of following sops um we'll talk a little bit and you know just for everybody's um information and education on the purpose of sops we said that they detail regularly occurring work or processes uh in our case where we're talking about laboratory control uh analytical instrument control we're talking about the regular reoccurring testing the regular calibrations and maintenance and operation of this equipment saps are also there because they document activities that are to be performed again with maintenance to maintain consistency with everything that we do uh maintain consistency through the calibration process through the um the testing process through the operation through the preventive maintenance they describe our types of analytical processes they also sops are there for validation and qualification processes as well we'll have sops for qualifying our equipment um we'll have processes for again maintaining and calibrating it what sops do is they do maintain the quality control and they maintain quality assurance in order to control to ensure compliance with government regulations gops glps those regulations that we are following so we have sops every sop is not going to be exactly uh like you know every company is going to have their different sops depending upon their own processes depending upon their specific industry um depending upon their specific manufacturing or what type of pharmaceutical drug that they're manufacturing so saps are going to be industry and um organization or manufacturing facility specifics now real quickly have a look at the components of the sops sap should always have a purpose they should identify a process or a procedure you should always state a scope of what this sop is going to cover typically we do include the responsibilities and an accountability section where we're saying you know it is the responsibility of uh lab analysts and technicians to uh follow this sop some simple statements like that and then we give accountability for it is management's responsibility uh to ensure the sops are followed so simple statements like that then you have your procedure section where you're actually uh describing the process step by step typically we'll have a safety section if there's any safety um concerns with the equipment do we need to wear goggles gloves you know things like that does it uh whatever the safety concerns are we'll list those in there and then some saps will have a training section um to discuss who should be trained on the sop now that is not always necessary uh if you have listed the responsibilities section whose responsibilities it is to uh follow the sop but the main components would be your purpose your process your procedure identification your scope your responsibility so sometimes there's possibilities accountabilities are combined and then of course your procedure and your safety section um really quick we want to talk about exactly what do sops need we already said that they need to detail regularly occurring reoccurring work processes uh that are are conducted within your organization that are being followed every day so this is it for your and your everyday uh testing um procedures your you know you have also your methods that should be written down and documented uh so we're documenting the way activities are performed because we what sops have to do is facilitate consistent conformance to technical equality system requirements also they are going to support data quality okay and of course our data quality is important we have to have quality results in order to release this product saps may also describe fundamental or pragmatic or technical actions again analytical processes they also again will give procedures and processes for calibrating and maintaining your equipment uh and using equipment and also cleaning we want to have sops for cleaning the equipment and how we um if there is anything uh in our laboratories any types of instruments that we need to break down and clean and we want to have sops we also want to have sops for storing um different types of equipment uh even down to you know forceps and um different little you know scissors and things that we might use and for cleaning those as well so what we have to understand with our sop that we have to make sure that we have in our saps or step-by-step instructions um referring to daily work that is completed and we want this we have these in place so that this work is performed the same every single time it is reliable and it is consistent and as long as we have reliable and consistent um work and we're following procedures we're doing things the same way every day then we're going to have control over our processes the next thing that we need to talk about is our analytical instrument qualification this is another step in controlling our information um one thing also as far as our sops i'd like to mention we need to have sops for weighing for pipetting anything that we're doing in our laboratory we want to have specific written instructions for doing these things um the next would be our analytical instrument qualification now we have analytical instruments qualified just as we qualify our um our manufacturing equipment because we have to show that the instrument is performing suitably for its intended use um when we have qualified our instruments and we have this documented evidence that the instrument is performing suitably for its intended use then it contributes obviously to the confidence and the validity of the generated data so we have to show that this instrument is going to do what it says it's going to do what the manufacturer says it's going to do and it's also going to meet our purposes in the laboratory so there are also requirements uh for our not only our manufacturing equipment but our analytical instruments to be qualified um and for our systems to be validated um the fda has requirements the european union has requirements and we can also see these requirements in the pics um if you depending upon which requirements if you follow canadian british requirements what whichever of those requirements that you're following they all are going to have requirements in there for qualifying your analytical instrument um there's requirements under the good laboratory practices as well the glp for qualifying your instruments um you want to be sure that the data that you're generating for uh new drug applications is accurate um and we do this again by qualifying and showing that our instruments are doing everything they are supposed to do and they're doing it on a consistent reliable manner uh the gmps of course have uh regulations the clinical practices have regulations there's also one regulations in 21 cfr part 11 which is your electronic records and signatures part of the code of federal regulations uh we any of our software systems our computer systems that are operating these instruments then we also have to have those validated we have to consider computer system validation and programs and making sure that those are reliable every menu and producing consistent information as well uh iso 17025 has regulations for qualifying instruments and i also mentioned the pics um in these regulations in for instance the gmps you'll see statements that instruments should be suitable for their intended use and instruments should be calibrated and maintained so those you can have a look at these regulations and see these requirements the pics the pharmaceutical inspection convention they also have requirements as we said for qualifying your instruments now they come out and if you'll have a look at the different regulations you'll see that some of the regulations will designate um iqo2pq some will designate user requirements in this slide for instance i put up the pics requirements um while they may come out and say okay this is our specific requirements they are all uh similar in what they are needing for equipment or analytical instrument qualification now you'll have a look the pics require user requirements they also require a design qualification along with their installation operational and performance qualifications of these instruments the thing that is a little bit different here is that they require the factory acceptance test now a lot of times that is considered part of the um the uh commissioning when the manufacturer is bringing in the equipment they'll do a factory acceptance test on site to make sure they have tested the equipment and they'll provide you with paperwork um and then of course sometimes we'll do a site acceptance test once it is on our site and then we'll go through the equipment qualifications with the dqiq oqmpq um this is just an example but have a look at the regulations and you'll see that basically they are requiring the same thing there may be a few specifics that are different so basically when we're talking about instrument qualification we are talking about a what we call a 4-q life cycle of the design qualification installation qualification the operational qualification and the performance qualifications and these are the four basics that you're going to find in all of the the regulations the requirements so how do we set up our instruments and how do we get them into a suitable if you will qualification program the best way that i have found is by a risk-based approach and this was uh you can find more information on this in the usp 1058 this is where we want to group our instruments according to risk so we have low medium and high risk instruments and we have a look at what we have in our laboratories where we're talking about risks our low risk um equipment and we can designate it as a b and c with c a being the lowest and c being the highest risk um we would have a look at what we have in our laboratories and any of our instruments that do not require have any measurement capabilities they're very simple instruments they do not have any calibration requirements things that are going to be simple would be your magnetic stirrers your shakers sonic bass vortex mixers these are your very simple instruments they're not requiring calibration and they're not uh having any types of measurement capabilities such as thermometers or things like that um for your qualification you would have your specifications that are simply defined by the manufacturer and you want to verify and show through documented evidence that these requirements have been verified and that they these instruments are meeting the manufacturer's uh specifications that you have observed that it and seeing the operation and it's a very simple document um for your for your uh qualification uh there would not be um well for a vortex mixer something that you're going to have to or a bath um things that you're going to have to sit on the counter and um hook up to an electrical outlet and things like that you would have a very basic installation qualification your operational qualification would just be simply defining and saying yes it meets these particular specifications uh set forth by the manufacturer and you would just document that you have observed it and seen it perform and again these are very simple and then of course in your documentation you would show that it does not have any maintenance excuse me any calibration um requirements any types of measurement requirements these are very very very basic simple instruments the next category would be your medium risk instruments um and these are going to be instruments they do have measurement capabilities um they do have uh controlled physical parameters so um they would be things that such as uh instruments for thermometers for taking temperature pressure gauges flow meters things like that um for these again the um the qualification approach um they may some of these such as balances uh ph meters different types of thermometers um like microscopes they may have their own usp general chapters and you can have a look at that you would want to have user requirements however the user requirements are going to be the same as the manufacturer's specifications of functionality and of course operational limits so these are fairly simple as well these will perhaps require calibration so you're going to want to include a calibration section in your protocols and then you're going to simply have your iqs and your oqs with your sops as hell as your editor because you're always verifying sop's operational sops and qualifications um so you're going to show that they conform to the requirements by your sops and they will have calibration requirements and then you will have an installation qualification for these instruments uh your balances you're going to have to show that they are installed in the correct environment they have um correct voltage if there's a any type of computer system operating those or even um you know any type of controller you're going to need to show that and then you're going to need to show that they do need a manufactured specifications in your operational qualification now for your medium risk and your low risk you may not have an apq which is a performance qualification and that's fine because these are your low risk instruments um in your medium risk instruments if there is a specific weight ranges that you're weighing for your scales and ph ranges that you're always measuring um you can perform a pq on those because your pq is going to show that these instruments meet your specific everyday requirements for use not just that they meet the manufacturer's requirements for use so some of these may or may not depending upon the type of instrument that they are your next would be your high risk instruments and these are going to be your more complex instruments that do have operational um computer systems and these instruments are going to require your full qualification process they will need user requirements for functionality they will obviously have operational requirements that need to be verified for the manufacturer and then of course they're going to have performance limits and these are going to be specific for your analytical application um they're going to definitely have specific um performance and function tests they're going to be needing to be tested per the application and their everyday use um so these are going to be things such as your hplcs uh particle analyzers uh your refrigerators your freezers your incubators even your autoclaves and your stability chambers so these are you're going to your very complex equipment you will want to start out with a dq then which is your design qualification and we'll discuss that in just a moment uh you will have an iq an oq and a pq for each one of these your most complex instruments what you do when you group these and you base your instruments on a risk then you gain advantage because you have a better faster simpler cheaper qualification process you're using uniform and consistent protocols this allows you to have basic templates for your simple instruments basic templates qualification protocol templates for your low medium and high risk instruments and then you're able to fill in the information you're creating harmonization um so this is uh to me it's if you don't have to create the wheel every time you're not writing a new protocol from scratch every time it allows um you can get these protocols written get them executed and get them reviewed by quality assurance and approved in a more timely manner and it makes it a lot easier and you have all of your instruments grouped so that you know the qualifications and the um the um what each instrument the how complicated each instrument is and what's going to be involved you have a one straight protocol for all of your various types of manufacturers and then you of course are just filling in information such as model numbers manufacturers names by doing this on a risk base you are going to improve your compliance and your productivity obviously you're going to simplify your testing because you do have standard tests and procedures that you're going to know is going to be needed for each different type of instrument um it gives you of course faster turnaround times for getting this information reviewed and of course it makes your paperwork uniform and it allows for quality assurance to review them on a faster basis as well so what the risk-based approach does is it simplifies grouping of course because you're grouping from lowest to highest it also can reduce the cost and it also is going to improve your efficiency because it does allow you to maximize the use of vendor documents and employees protocol harmonization now i do have to caution against vendor documents you can use vendor documents for these and for your simple ones it's very it's fine to do this when you use a vendor document however i would if you use a vendor document please have your quality assurance department review it and approve it just like you would with your protocols you're going to write your protocols route them for review and approval for management and quality assurance so you want to do the same thing with these have a cover page and have them have approval page so that you know that management and quality assurance has reviewed them for thoroughness accuracy and that they are including everything that's needed because sometimes vendor protocols do not include everything that is necessary the vendor doesn't have a way of knowing exactly what is needed for your facility so just be sure that you do have those reviews a lot of time we did say that user requirements are required and particularly for your complex instruments um we refer to user requirements as urs's um one thing we want to understand about user requirements is they have to be comprehensive um we want to be sure that they are also testable all of your user requirements have to be testable um so you want to look at each and every requirement for that piece of that analytical instrument as it relates to product safety identity um also strength security and quality so you want to have quality assurance has to have again a significant role in reviewing and approving your user requirements just as they do uh your iq ogs and pqs um so your user requirements are very important um the one thing i think that i do see a lot of is remembering that user requirements have to be comprehensive and they have to be testable and they have to be reviewed by your quality assurance group as well for a dq your design qualification the fda is now moving towards requiring this and this has not always been a requirement unless you had a specific piece of equipment or analytical instrument designed for your in your specific use um now the fda and other regulatory bodies are requiring a design qualification so what the design qualification is um it is used at the design phase obviously we want to show that this instrument has been developed from the vmp from the user requirements uh from other health and safety guidelines we want to be sure it has been reviewed and documented by competent people because we're ensuring the design of the equipment that it is built or it hasn't built or if it is built that it will satisfy all of the detailed specified requirements that it's going to function as it is designed to function as it is required to function so that's what we're doing with a design qualification um we are showing that this instrument was built or it has been built in order to function as it is as as needed so it was specifically designed to do these particular processes for your installation qualification um your installation qualification is going to be the process of checking the installation you want to show documented evidence that the instrument has the correct component that it needs to operate properly that it has been installed properly in the proper environment the installation qualification is to ensure that all aspects of the facility and or your equipment are installed correctly and that they comply with the original design you want to be sure that you're documenting within your installation qualifications that your software that's operating the equipment is updated it is the correct software it's in the correct environment there is uh has enough room in that environment to operate properly um that there are the uh proper sops for this equipment that this equipment or this analytical instrument is um doing is is installed correctly um and that it will function in this environment the noise level uh different types of text wanting to make sure that you have calibration procedures in place for this that anything on that instrument that needs to be calibrated is going to be calibrated at regular intervals so that is what your installation qualification is documenting your operational qualification is documenting um what the manufacturer says this instrument will do so it's testing to ensure that the individual or combined systems will function to meet performance criteria as specified by the manufacturer you want to ensure that it does also comply with original design that it is going to do exactly what the manufacturer says that it will do you want to check the instrument's functions um to ensure that they conform to the specifications now these are not conforming to uh your specific specifications for the test that you're running uh it's conforming to what the manufacturer says um so for instance if you have um a ph meter and i'll give you a very uh simple simple um illustration that the manufacturer says you know it will detect ph from you know one to ten um you're checking to make sure that it does that um if you have uh an autoclave or a refrigerator and if the manufacturer says refrigerator for instance the manufacturer says you know it will the temperature range is i don't know say 2 to 10 degrees c then you check your testing should show that it is running within those specified temperatures um so what you're doing with your your oq is you're showing that it will meet manufacturer specifications your iq you're showing that it's installed correctly your oq you're showing that it will meet manufacturer specifications uh you want to be sure that you do have an iq performed on each piece of analytical equipment before you move on to your oq your oq needs to be performed for each different use of your equipment each or system if even if you have the same model and type because you want to document suitability for the use okay so if you have um instruments that are being used they're the same instruments and they're being used for different processes or different types of testing you would need to perform an oq for each one of those types of testing you do not it is not a requirement to perform an oq for the same model or the same type of equipment that is for the same use but it is if they are going to be for different uses but you do have to have your iq performed for before you can begin your oq the next way part of our qualification is your performance qualification your performance qualification is documented evidence that your instrument is consistently performing according to specifications that are appropriate which routine use so you're going to have particular test methods that you're going to routinely run on this analytical instrument and what you're showing in your performance qualification is that okay in your oq it means specific manufacturers settings and specifications in your pq it's meeting its everyday routine uh specifications uh and meeting those particular parameters so um in your pq your performance excuse me your testing is going to be a little bit higher uh level testing than your oq because it is for your particular function for your facility for that everyday use of that instrument another thing another way once we have our standard operating procedures in place we have documented evidence of our user requirements and our qualification processes all of this remember is we are qualifying and documenting this qualification we're providing user requirements in order to show controls um to show that we have tested these instruments and they're going to perform consistently reliably uh and they're going to do the same meeting the same parameters every time and this is how you establish control um the last thing that you're going to need to do for control is to re-qualify your instruments you do not want to qualify them one time and say that this is all i'm ever going to need to do because you want to have continuous confidence in your analytical results for the entire life of that instrument so you're going to need to put your instruments set up your instruments in a re-qualification program um your simple instruments those types are a lot of times you're just gonna have that generate that protocol as they come in if they're instruments that you are using over and over for long periods of time then you can show uh go back through that qualification and verify that it's continuously working and meeting those qualifications and your medium risks the same way for your higher your critical uh your most complex instruments like your incubators refrigerators your hplcs um gcs different things like that you are going to set these instruments up on an annual qualification basis where you're basically going back through the operational qualification and retesting and saying yes it's still meaning this test case is still meaning this also if you've updated sops if you change something about the operation then you need to um show that and then it's meeting the requirements it's operational requirements uh and also its performance requirements and you need to do this annually if the instruments are not critical you can re-qualify them on an every three to five year basis i would not go myself over three years but it is acceptable to have them on a three to five year requalification basis what you're doing when you're re-qualifying is of course you're retaining confidence um that the instrument is continuously working and also you're showing inspectors uh from whatever regulatory body that the instrument has maintained its qualified state uh you do not perform an iq because obviously it is installed correctly um again i jumped ahead of myself a little bit but the re-qualifications every two to three years and it can go out as far as five years for your instruments that are not critical and anything that is critical should be done on an annual basis the last way of maintaining control is going to be through quality auditing you want to set up and again everything that we do in our labs everything needs to have an sop so you need to have a standard operating procedure for carrying out quality audits you need to have a standard operating procedure for carrying out quality equipment qualifications and writing protocols as well as how your equipment operates and cleaning your equipment and storing your equipment um and the everyday functions of your laboratory because when you have it written down and you have it documented and everyone is following it then everyone is doing the same thing on a consistent reliable basis and they're doing it the same and you're getting the very same manufactured product the same test results every single time um if there is anything that is not testing the testing comes back failing then you're obviously going to be able to detect it and reject the product and you're going to be assured that you're releasing um quality product all the time so the last thing would be your quality audits and quality auditing is basically the process of systematic examination of a particular quality system whether it is internal or external and it can be done by an internal audit team or an external audit team you want to have your procedures audited on a regular basis have a lot of times we do have the qa quality assurance department will come in they'll audit and look at the performance the analysts and what they're doing i have the equipment operation and look at the overall operation of the laboratory they'll have a checklist that they go by and they'll say yes everything is performing or they may make some citations or some observations if we say they're not citations by a regulatory body um and they'll you know say okay i observed this and this person wasn't following the sop or the gowning wasn't appropriate for the laboratory we do also need to have appropriate gowning with lab coats and appropriate ppe is necessary for operating the equipment and all of that would be an sop so when we're auditing we're looking at all of this and we're having checklists and making sure that everything is in compliance that way when we have an inspector to come in we're not going to get cited and they're going to ask also to see our internal audits and see what we have um have done the audit to help determine if the organization is of course compliant with your quality system processes again it is procedural and results-based assessment they may also look at your test records we want to be sure that we have uniform test records we want to be sure that we have sops that are in a documentation system so all of this is a way to make sure that your analytical instruments are in a state of control and that you're performing on performing correctly the same consistent spaces every single day um thank you we will now open for any questions that you may have thank you joy for your informative presentation we will now start the live q a portion of the webinar we already have some great questions coming in so while i give joy a few moments to review the questions that have already come in i want to remind our audience how to submit questions just click on the ask a question box located on the far left of your screen we'll answer as many of your questions as we have time for okay joy which question would you like me to start with um just give me one second i am okay i see them now um we can start with um number two number two are user requirements necessary for simple instruments such as pipette yes use the requirements for your simple instruments are going to be basically what the um the manufacturer says that they will do so um let me say that when you write user requirements it's not necessary for your simple instruments uh because basically your user requirements are going to be um the functionality of that instrument for your simple instruments now when you move into your medium risk and your complex instruments yes you will need to have user requirements for your simple instruments if you would like to write a section of user requirements is going to be the basic um functionality and specifications as set forth by the manufacturer okay thank you joy what other what's the next question um let's see let's um let's see number 17 number 17 this question is is an interesting question how many times should equipment be calibrated before performance well that's going to depend on the type of equipment that it is for instance and it's also going to depend upon the manufacturing requirements um for example if it's a simple uh ph meter then you may need to calibrate it before each use um if it is a scale obviously we calibrate those before each use if you're talking about your performance qualification you're going to show your your calibration uh within your operational qualification but for your everyday use it's going to depend on what type of equipment and how often your manufacturer requires that it needs to be calibrated like i said some things like scales balances ph meters may require a once a day calibration before the initial use of the day and others may not um so i would refer to the um the manufacturer's manual for the calibration and you can also put that in your sop for the operation of the particular instrument alrighty um let's i see question number one number one okay how often should sops be reviewed for accuracy that's a good question too thank you uh so much um sops should be reviewed for accuracy on at least a bi-annual basis i have seen some companies that will review them annually and some companies will review them every three to five years first of all you need to for your price for your process validations we are constantly looking at our processes and updating sops as necessary um for your analytical applications um i would review these sops i do not like to go over two years without reviewing the sop for accuracy remember that anytime you change an sop or a function on a piece of equipment or you change the use then obviously you're going to have to have that instrument requalified but your sops need to be reviewed for actually in my opinion at least on a bi-annual basis okay let me see i'm just looking at the questions um okay i key number 15 that that looks like this number two question 15 okay here we go uh is it mandatory for academic research institutions working on funded projects from industry needs to have sops and follow them um if you are being funded from a you know a regulated industry yes um i would yes you need to have sops because that industry is going to be ultimately responsible for your work i think that it is a good idea to have sops regardless because what sops do again establish everyday working processes that are going to be performed we understand that sometimes when you're doing research or doing a project for a funded industry a funded project from an industry that you're not going to maybe have consistencies based on the different type of research but you can have sops for different for basic operation of your equipment basic functions in your laboratory so um it and then ultimately if the industry is funding then they're going to be ultimately responsible so yes you should have sop okay okay great well we have time for one more question today i want to remind our audience that those yep i want to remind our audience that uh those questions we were unable to answer and those that come in during the on-demand period will be answered by joy via the email address you provided at the time of registration so our final question joy um give me i'm sorry give me one second because i i see a quite a few and i'm i don't want to leave anyone out but we will get them answered um okay there's how about number number 28 number 28 okay quality audits may be internal or external what about requalification should it be done only by the original quality certifier now by the original quality certifier i'm assuming you're talking about your original equipment manufacturer re-qualifications can be done by either one the original equipment manufacturer or by your own validation department within your facility if you're if you have an outside the equipment manufacturer coming in to qualify this instrument and they are using their documents again have your quality assurance and your management review those documents for accuracy and making sure that they have what is needed in those documents per your facility um typically i like to see companies perform their own requalifications like to see them perform their own qualifications with their own documents because you know what is needed for your piece of equipment and you don't have to go through sometimes a bunch of requirements that are not necessary so it is my opinion that you should qualify your instruments initially you may use sender documents you may have the vendor come in sometimes you do buy that service um and that is perfectly fine to have the original equipment manufacturer to come in and qualify the instrument and to come back and forth and perform the re-qualifications on that instrument as long as they're doing it according to your standards and meeting your quality parameters and that paperwork those protocols are have all of the requirements that are necessary for you um otherwise then you should re-qualify your own instrument on your own re-qualification schedule um because you as the manufacturer you as the uh manufacturing facility know your specific testing you know your specific requirements for that instrument but either way is sufficient i just want you to make sure that you are reviewing what the um original equipment manufacturer is doing with the qualification process if you choose to use them oh and one more thing i'm sorry all of your documents should be and also your vendor document should be signed off approved by management equality assurance okay well thank you again joy do you have any final comments for our audience today yes and thank you um i just want to say i appreciate your attendance um when you the one thing i wanted to say is through this the purpose of this types all these types of documentation from your sops to your equipment qualification protocols to performing your quality audits um obviously you're documenting that your equipment your testing is in a state of control and that you're producing quality uh data and then thereby releasing quality product it is really all about documentation uh be sure that you are documenting uh everything that you're doing and um that your quality assurance department and your policy control um quality assurance excuse me is involved and they're signing off and reviewing each of these documents because your control is coming from your documentation a lot of times the fda if they don't see it and it's not written down it didn't happen and that is the only way as inspectors that we can see that you are doing what you're supposed to be doing and you're doing it in a consistent reliable controlled manner so again i just thank you for your attendance today thank you very much thank you again joy mcilroy for your time today and your important research we would also like to thank lab roots and our sponsor sartorius for underwriting today's educational webcast before we go i'd like to thank the audience for joining us today and for their interesting questions questions we did not have time for today and those submitted during the on-demand period will be addressed by the speaker via the contact information you provided at the time of registration this webcast can be viewed on demand lab routes will alert you via email when it's available for replay we encourage you to share that email with your colleagues who may have missed today's live event until next time goodbye