WEBVTT 00:00:02.002 --> 00:00:05.005 so what are current good manufacturing practices? 00:00:05.238 --> 00:00:09.342 So they are what is in the Code of Federal Regulations 00:00:09.342 --> 00:00:15.348 that they feel is makes the product safe for people to use and make sure 00:00:15.348 --> 00:00:19.352 that if you get blood in Utah, you get blood in California, 00:00:20.020 --> 00:00:25.325 everything is still safe, regardless of what how you do it. 00:00:25.325 --> 00:00:30.063 Each laboratory may do it differently, but we want the end result to be the same 00:00:30.630 --> 00:00:33.633 a safe product for a patient. 00:00:34.834 --> 00:00:37.670 And they again are established 00:00:37.670 --> 00:00:43.143 to ensure the safety, quality and purity characteristics of a drug. 00:00:43.143 --> 00:00:46.413 And those are the three words that they use a lot the FDA, 00:00:46.813 --> 00:00:49.816 the quality, potency and safety of a product. 00:00:50.550 --> 00:00:52.152 And they are the law. 00:00:52.152 --> 00:00:54.120 So you have to do it. 00:00:54.120 --> 00:00:56.222 A lot of you'll hear cGMP, 00:00:56.222 --> 00:01:00.060 which is current good manufacturing practices or just GMP. 00:01:00.060 --> 00:01:02.595 A lot of people in industry just stop the C. 00:01:02.595 --> 00:01:04.097 So the C is just current. 00:01:05.131 --> 00:01:07.700 So they'll change these with any changing times. 00:01:07.700 --> 00:01:10.236 Like for testing regulations. 00:01:10.236 --> 00:01:16.076 For instance, if when we implemented West Nile testing changes to hepatitis 00:01:16.076 --> 00:01:19.446 B, any of that, we're testing current with the regular 00:01:20.814 --> 00:01:23.817 with the technology and what's available. 00:01:25.685 --> 00:01:28.321 So why do we have to do this? 00:01:28.321 --> 00:01:31.591 Because it's a law and it applies to everyone in transfusion service. 00:01:32.158 --> 00:01:34.928 So if you do processing, 00:01:34.928 --> 00:01:38.731 compatibility testing, if you store, if you issue 00:01:39.299 --> 00:01:43.503 anything with a blood product, then you have to follow these regulations. 00:01:44.137 --> 00:01:47.373 And that is the code that says that everyone has to. 00:01:51.811 --> 00:01:55.048 So what are the good manufacturing sections of the code 00:01:55.248 --> 00:01:56.182 that we have to follow. 00:01:56.182 --> 00:01:59.953 So you have the 210, which is current good manufacturing 00:01:59.953 --> 00:02:03.123 practices for processing, packing and holding of drugs. 00:02:03.756 --> 00:02:04.991 There's blood as a drug. 00:02:04.991 --> 00:02:08.161 So we're going to process it into its final form. 00:02:08.161 --> 00:02:12.165 And then we're going to hold it or store it until it's needed. 00:02:12.966 --> 00:02:15.401 And then 211 00:02:15.401 --> 00:02:18.271 is the finished pharmaceuticals. 00:02:18.271 --> 00:02:20.140 So again blood is a drug. 00:02:20.140 --> 00:02:25.712 So once it's finished, how they mostly deal with labeling and quality of the lot. 00:02:25.712 --> 00:02:32.118 So each unit of blood has a unique identifier and that is its lock number. 00:02:32.552 --> 00:02:36.156 So in a prescription or different pharmaceuticals 00:02:36.422 --> 00:02:39.259 there will be thousands of bottles that have the same 00:02:39.259 --> 00:02:42.262 lot number because they were all produced at the same time. 00:02:42.295 --> 00:02:45.965 So in blood products, each product that was collected 00:02:45.965 --> 00:02:49.969 from that donor at that time has the same number. 00:02:49.969 --> 00:02:55.141 And that is what they consider the lot for that, particular unit. 00:02:55.742 --> 00:02:58.144 And then 6 or 6 is blood. 00:03:00.513 --> 00:03:01.915 Regulations. 00:03:01.915 --> 00:03:05.518 So in part 211 is important to us 00:03:05.518 --> 00:03:09.656 because that's where it says that you must have a quality unit. 00:03:10.523 --> 00:03:12.992 And that is my position at r u p. 00:03:12.992 --> 00:03:16.396 So you have to have someone who is an outside 00:03:16.396 --> 00:03:19.399 voice to review the things that are done 00:03:19.732 --> 00:03:23.703 in the transfusion service or the blood service, laboratory. 00:03:24.137 --> 00:03:28.241 So I don't report to anyone in transfusion service, 00:03:29.075 --> 00:03:31.678 my supervisors outside 00:03:31.678 --> 00:03:36.015 of that entire department so I can go in and say, you know, 00:03:36.482 --> 00:03:38.551 I really don't agree with you, 00:03:38.551 --> 00:03:43.556 and there's no chance that I could have any negative impact 00:03:43.823 --> 00:03:49.162 because that's my supervisor or she's my boss or anything like that. 00:03:49.462 --> 00:03:51.097 So you have to be removed. 00:03:51.097 --> 00:03:54.100 And the, code requires that you have someone like that 00:03:54.434 --> 00:03:57.437 when you manufacture blood products. 00:03:57.437 --> 00:04:00.340 So if you're just a small transfusion service in a hospital 00:04:00.340 --> 00:04:03.343 and you're not manufacturing any products, 00:04:03.543 --> 00:04:07.380 then you wouldn't necessarily need to have a quality unit. 00:04:07.680 --> 00:04:09.315 But if you're making any products, 00:04:09.315 --> 00:04:13.553 if you're irradiating products, if you're making out clots, you're manufacturing. 00:04:13.553 --> 00:04:15.755 So you have to have a quality unit. 00:04:18.458 --> 00:04:18.825 So if 00:04:18.825 --> 00:04:22.662 there are all three of these regulations and they're all, good 00:04:22.662 --> 00:04:26.499 manufacturing practices, how do we know which ones we're supposed to follow? 00:04:27.767 --> 00:04:29.535 So the code tells us 00:04:29.535 --> 00:04:32.538 that you follow whichever is more specific. 00:04:32.538 --> 00:04:34.741 And that's also in part 211. 00:04:34.741 --> 00:04:38.811 So if there's a regulation that applies to a situation 00:04:39.312 --> 00:04:42.415 both in the drug section in the two hundreds 00:04:42.915 --> 00:04:45.818 and in the biologics section in the six hundreds, 00:04:45.818 --> 00:04:49.589 we're going to follow the 600 code because we're dealing with blood. 00:04:50.290 --> 00:04:53.092 So we're going to pick whichever one is more specific. 00:04:53.092 --> 00:04:55.295 And there is a lot of redundancy. 00:04:55.295 --> 00:05:00.400 So there are many cases where a situation is covered in many sections of the code, 00:05:00.667 --> 00:05:03.169 and we have to pick which one we're going to follow. 00:05:03.169 --> 00:05:08.107 And generally you do that by whichever product you're speaking about. 00:05:11.377 --> 00:05:14.213 So the purpose again 00:05:14.213 --> 00:05:18.451 we want to assure the safety purity, potency of blood products. 00:05:19.285 --> 00:05:23.489 Ensure that systems involved in manufacturing are controlled 00:05:23.856 --> 00:05:27.026 and that we always get the same product at the end 00:05:27.527 --> 00:05:31.264 to ensure patient and donor safety and that we remain current. 00:05:31.631 --> 00:05:36.002 So again, we change things based on new, diseases. 00:05:36.002 --> 00:05:39.005 So right now they're talking about, 00:05:39.138 --> 00:05:42.342 chikungunya and all these new infectious agents 00:05:42.342 --> 00:05:45.378 that maybe we're going to start testing for maybe or not. 00:05:45.778 --> 00:05:48.581 Is there a valid test for that? 00:05:48.581 --> 00:05:51.584 What would be the impact on the blood supply? 00:05:52.085 --> 00:05:54.120 And they have a group 00:05:54.120 --> 00:05:57.590 in the FDA that reviews all these things 00:05:57.590 --> 00:06:01.260 and data makes decisions, and then they put out guidance 00:06:01.761 --> 00:06:04.764 and new regulations if we need to follow them. 00:06:06.466 --> 00:06:10.236 So what elements are covered in good manufacturing practices. 00:06:10.236 --> 00:06:12.405 So they cover pretty much everything. 00:06:12.405 --> 00:06:13.773 So they have general provisions. 00:06:13.773 --> 00:06:19.078 They have organization training standard operating procedure. 00:06:19.078 --> 00:06:21.748 So they say you have to have procedures. 00:06:22.882 --> 00:06:24.817 Labeling what kind of records 00:06:24.817 --> 00:06:27.820 you have to keep, how long you have to keep them. 00:06:27.920 --> 00:06:31.991 Error management and then error reporting, which is again unique. 00:06:32.358 --> 00:06:34.794 They're called biologic product deviations. 00:06:34.794 --> 00:06:36.596 And we'll talk a little bit more about those 00:06:36.596 --> 00:06:39.365 because there have to be reported to the FDA 00:06:39.365 --> 00:06:42.368 within 45 days of discovery. 00:06:45.471 --> 00:06:48.474 So what are the rules, 00:06:48.541 --> 00:06:51.544 for regular registration versus licensure? 00:06:51.644 --> 00:06:57.483 Has everybody heard anything about blood banks being register license. 00:06:57.850 --> 00:06:59.652 Does that new. 00:06:59.652 --> 00:07:01.154 Probably okay. 00:07:01.154 --> 00:07:04.157 So you have to be everyone has to be registered 00:07:05.124 --> 00:07:07.493 to have a business 00:07:07.493 --> 00:07:10.496 as a transfusion service or as a blood donor. 00:07:11.130 --> 00:07:13.566 Not everyone has to be licensed. 00:07:13.566 --> 00:07:19.071 So the difference is if you are going to ship products across state lines. 00:07:19.772 --> 00:07:22.275 So they call it in interstate commerce, 00:07:22.275 --> 00:07:24.777 you have to be a licensed blood center. 00:07:24.777 --> 00:07:29.081 So to be licensed you have to submit all of your SOPs 00:07:29.315 --> 00:07:34.854 quality plans, submit a big form and then all the documentation of training. 00:07:34.854 --> 00:07:35.955 How do you do training? 00:07:37.156 --> 00:07:38.658 All that type of information. 00:07:38.658 --> 00:07:42.528 And then you submit it to Sieber, and then they'll come out and do what's 00:07:42.528 --> 00:07:46.199 called a pre, inspection survey 00:07:47.099 --> 00:07:50.102 or a pre licensure survey or inspection. 00:07:50.436 --> 00:07:53.439 And they can last anywhere from a couple of weeks to a couple of months. 00:07:54.507 --> 00:07:57.510 And these inspectors come from Sieber, 00:07:58.077 --> 00:08:00.279 in Maryland. 00:08:00.279 --> 00:08:03.716 So they're not the same inspectors as the people that will come, 00:08:03.716 --> 00:08:07.854 the field investigators who come and do normal, inspections. 00:08:08.254 --> 00:08:12.291 So they're a little bit more focused on the back end, like, how are you set up? 00:08:12.825 --> 00:08:15.828 How do you deal with changes, that type of thing. 00:08:16.362 --> 00:08:20.132 But the regulations and the ongoing inspections are always the same. 00:08:20.399 --> 00:08:23.402 But that's basically the difference between, 00:08:23.769 --> 00:08:26.772 licensure and registration. 00:08:27.273 --> 00:08:29.709 So this is just a copy 00:08:29.709 --> 00:08:32.712 of what a registration or a license looks like. 00:08:32.778 --> 00:08:34.046 So you have to say, 00:08:35.882 --> 00:08:38.484 what kind of products am I collecting. 00:08:38.484 --> 00:08:42.488 So am I doing Allergan and am I doing autologous? 00:08:42.922 --> 00:08:44.423 What kind of things am I doing? 00:08:44.423 --> 00:08:45.324 Is it red cells? 00:08:45.324 --> 00:08:47.627 Is it frozen? Is it platelets? 00:08:47.627 --> 00:08:49.028 What am I collecting? 00:08:49.028 --> 00:08:51.197 And then what am I doing with it? Am I testing it? 00:08:51.197 --> 00:08:54.400 Am I storing it? Am I distributing it? 00:08:54.834 --> 00:08:58.471 So basically on one sheet says everything that you do 00:08:58.838 --> 00:09:02.375 in your laboratory documentation is huge 00:09:02.508 --> 00:09:06.345 for the FDA and they're mantra. 00:09:06.345 --> 00:09:10.182 I guess you would say if it wasn't documented, it didn't happen. 00:09:11.484 --> 00:09:15.421 So I could have everything except the document 00:09:15.421 --> 00:09:18.658 that says I did this at this time, and I wrote it down. 00:09:19.592 --> 00:09:21.627 You didn't do it. 00:09:21.627 --> 00:09:25.831 If you can't find the documentation for the inspector, why the inspector is there. 00:09:26.232 --> 00:09:27.700 You didn't do it. 00:09:27.700 --> 00:09:28.935 You will be cited for that. 00:09:29.969 --> 00:09:33.706 So documentation is very critical, for the FDA. 00:09:33.706 --> 00:09:38.010 So there are specific rules they have to maintain concurrently. 00:09:38.010 --> 00:09:39.278 Not after the fact. 00:09:39.278 --> 00:09:44.050 So if I have 6 or 7 balances that I'm doing the QC on in the morning, 00:09:44.050 --> 00:09:47.954 I can't go this 1 to 500, this 1 to 500, this 1 to 500. 00:09:48.154 --> 00:09:50.122 And then write all three down. 00:09:50.122 --> 00:09:53.693 I have to put the weight on, write it down, put the weight on, write it down. 00:09:54.160 --> 00:09:56.829 So it has to be concurrent while I'm doing it. 00:09:56.829 --> 00:09:57.997 Not after the fact. 00:09:57.997 --> 00:10:01.834 So like in the transfusion service, I'm reading my tubes, shaking my tubes. 00:10:01.834 --> 00:10:04.837 This is my blood type. Read it, put it in. 00:10:04.971 --> 00:10:08.641 I can't read it, set it down, do something else and then put it 00:10:08.641 --> 00:10:09.342 in the computer. 00:10:09.342 --> 00:10:12.211 It has to be concurrent as you're doing it. 00:10:12.211 --> 00:10:14.647 Everything has to be clearly traced. 00:10:14.647 --> 00:10:17.984 So each step in the process has to be clearly identified. 00:10:17.984 --> 00:10:20.753 And you have to be able to follow the process through. 00:10:20.753 --> 00:10:23.222 The documentation has to be legible. 00:10:23.222 --> 00:10:24.090 And indelible. 00:10:25.091 --> 00:10:28.094 So indelible it can't be erased. 00:10:28.160 --> 00:10:31.163 So no gel pens. 00:10:31.464 --> 00:10:34.467 Have you ever smeared a gel pen, gotten it wet? 00:10:35.401 --> 00:10:36.402 It rubs off. 00:10:36.402 --> 00:10:39.605 No gel pens in the laboratory, no pencils. 00:10:40.473 --> 00:10:43.442 Now, wite-out any of that kind of stuff. 00:10:43.676 --> 00:10:46.412 It has to identify the person performing the work. 00:10:46.412 --> 00:10:49.415 So what, you're doing it in the computer, it can be your computer log in. 00:10:49.982 --> 00:10:52.952 If you're doing something by hand, it needs to have your tech ID 00:10:53.119 --> 00:10:54.987 or something defined by the laboratory. 00:10:54.987 --> 00:10:59.291 That shows that Becky is the one that wrote that at this time. 00:11:00.660 --> 00:11:02.762 And then it has to have dates. 00:11:02.762 --> 00:11:05.731 So I did this and put my initials in the date. 00:11:05.998 --> 00:11:08.734 So it has to show what day that you're doing stuff. 00:11:08.734 --> 00:11:12.038 It has to be detailed as necessary to have a complete history. 00:11:12.571 --> 00:11:14.907 And they don't tell you what that is. 00:11:14.907 --> 00:11:17.910 So they don't say you have to document this, this and that, 00:11:18.144 --> 00:11:20.246 but they say you have to have a complete history. 00:11:20.246 --> 00:11:23.883 So the inspectors should be able to come in, ask for a record 00:11:23.883 --> 00:11:26.919 and be able to follow it on their own and know exactly what happened. 00:11:26.919 --> 00:11:28.421 And who did it and when. 00:11:30.022 --> 00:11:33.059 And then again, records have to be maintained and available. 00:11:33.426 --> 00:11:36.028 If you can't produce the record. 00:11:36.028 --> 00:11:37.029 It didn't happen. 00:11:37.029 --> 00:11:40.032 It wasn't done. 00:11:42.268 --> 00:11:44.970 So again, record all actions as are happening. 00:11:44.970 --> 00:11:46.605 Use blue or black ink. 00:11:46.605 --> 00:11:51.177 No gel pens, no pencils, no whiteout or correction tape. 00:11:51.544 --> 00:11:54.780 You don't want to scratch out or write over anything. 00:11:55.147 --> 00:11:58.150 You have to be able to see what was originally written below. 00:11:59.118 --> 00:12:02.688 So if you make a mistake, everybody makes a mistake once in a while. 00:12:02.688 --> 00:12:05.691 When you're writing things, you just have to use the correct, 00:12:06.092 --> 00:12:08.928 procedures for your laboratory for correcting errors. 00:12:08.928 --> 00:12:11.931 Some laboratories, and generally in clinical, 00:12:12.298 --> 00:12:15.301 trials situations, if you're doing testing for them, 00:12:15.468 --> 00:12:18.471 they also want to document why you made the change. 00:12:18.838 --> 00:12:20.506 It was an error. 00:12:20.506 --> 00:12:23.509 It was a typo. Why am I changing this. 00:12:23.576 --> 00:12:27.880 So that's something you may, encounter as you work in laboratories. 00:12:28.748 --> 00:12:30.883 So this is just an example 00:12:30.883 --> 00:12:33.552 of really bad documentation. 00:12:34.620 --> 00:12:37.289 So we don't need any 00:12:37.289 --> 00:12:41.260 embellishments, no smiley faces, no commentary. 00:12:41.260 --> 00:12:45.531 Like yes, the temperature was finally in any of that. 00:12:46.899 --> 00:12:48.768 Right overs. 00:12:48.768 --> 00:12:53.072 So obliterating things, arrows are not allowed 00:12:53.072 --> 00:12:57.510 unless there's a clear, open and ending time for an arrow quotation 00:12:57.510 --> 00:13:00.546 marks are not good, so you can use an arrow 00:13:00.546 --> 00:13:03.682 if it's clear that I'm starting here and I'm ending here. 00:13:04.650 --> 00:13:07.052 But if you just have, quote 00:13:07.052 --> 00:13:10.022 blank spots, you should never have a blank. 00:13:10.656 --> 00:13:11.490 It's the form. 00:13:11.490 --> 00:13:15.194 If you have a form and you don't need to use that space, you should fill it out. 00:13:15.194 --> 00:13:18.664 Is any because I intentionally left it blank. 00:13:20.933 --> 00:13:25.204 So we don't need oops, none of that. 00:13:27.273 --> 00:13:30.509 And why are we so specific about this stuff? 00:13:30.509 --> 00:13:32.444 Because documents are legal. Records. 00:13:33.512 --> 00:13:36.515 So if there's ever a recall or a look back. 00:13:36.715 --> 00:13:40.352 So we find information out about a donor later on, 00:13:40.653 --> 00:13:43.556 they come back testing positive for a certain disease. 00:13:43.556 --> 00:13:47.827 We have to look back for ten years on that donor and any donations 00:13:47.827 --> 00:13:50.830 and where that unit went to and who it went to. 00:13:50.996 --> 00:13:52.832 We need to be able to find this information 00:13:52.832 --> 00:13:54.900 and clearly understand who it is. 00:13:54.900 --> 00:13:59.705 And if it comes up in a legal case, these are going to be presented in court. 00:14:00.005 --> 00:14:03.008 They're legal documents. 00:14:04.677 --> 00:14:05.978 And they have to again 00:14:05.978 --> 00:14:10.082 track ability every step from beginning to end. 00:14:10.082 --> 00:14:13.886 Each critical step has to be documented, just like the falling dominoes. 00:14:13.886 --> 00:14:16.889 This happened and then this happened and this happened. 00:14:17.723 --> 00:14:19.792 So and again, 00:14:19.792 --> 00:14:22.862 if it didn't wasn't documented, it didn't happen. 00:14:26.665 --> 00:14:27.166 So the 00:14:27.166 --> 00:14:30.202 critical information we're documenting, the who, the what, the how. 00:14:30.436 --> 00:14:32.972 And then usually there's a review. 00:14:32.972 --> 00:14:35.341 So who made sure that this information is correct 00:14:35.341 --> 00:14:40.145 sometimes that in the computer system automatically built in your front type 00:14:40.512 --> 00:14:43.515 matched with your back type, or you get some sort of an error, 00:14:44.083 --> 00:14:47.086 the information you entered is not, 00:14:47.586 --> 00:14:48.954 compatible with life. 00:14:48.954 --> 00:14:52.758 You'll usually get some kind of a flag in the computer system. 00:14:53.158 --> 00:14:56.362 If it's a completely manual documentation, you usually have something 00:14:56.362 --> 00:14:59.632 with peer review or supervisory review. 00:14:59.632 --> 00:15:02.635 After the form is completed. 00:15:04.203 --> 00:15:06.238 And again, why do we have so many reviews? 00:15:06.238 --> 00:15:09.241 Just make sure everything is correct and current, 00:15:09.775 --> 00:15:12.511 and the reviewers are responsible for finding errors. 00:15:12.511 --> 00:15:15.481 So we don't want to say oops, 00:15:17.283 --> 00:15:20.552 Justin has worked in the blood bank forever. 00:15:20.786 --> 00:15:22.521 I'm reviewing his work. 00:15:22.521 --> 00:15:25.524 Let me just skim over this. It'll be fine. 00:15:25.591 --> 00:15:30.362 No, we want to make sure that you review everything thoroughly 00:15:30.562 --> 00:15:33.332 and make sure you're catching anything, because that's why we do it. 00:15:33.332 --> 00:15:34.800 If it wasn't important, 00:15:34.800 --> 00:15:38.137 we wouldn't take the time to have another person review something.