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Write initial validated

so we're going to continue on with the talk about documentation and you know I listed you know in the handout the main thing I want to focus on is the outlines because that says these are the pieces that are important for each document I also list the problems I mean the problems you can read the problems and it's those are actual problems that I experienced so I didn't make them up but I want to really focus on the outlines and the content because that's what's gonna give you the most information so okay so initiating validation those five bullet points those are the key points of the outline and again we're gonna make some model documents and we're going to say fellas this is what we want you to write simple direct and to-the-point okay here just to show you the simplicity validation request process validation product a new product reason new product to be manufactured at the site period that's all they need then this other little stuff oh yeah it's gonna be compliant with policies gonna be regulatory approved we need to do cleaning I mean very minimal information that's all you need at this stage we don't want you know sometimes people go nuts writing we don't want that when we want people to go nuts writing is in the validation plan that's where we want very clear and complete writing and explanation because that's the key document this stuff that's all you need okay qualification of a new blender new equipment high-impact new sighs okay very simple essentially that's that's all we need to start the validation okay what's key is the plan you see that on the bottom see validation plan that's going to tell us the details of how we're going to validate that or qualify that piece of equipment simple and clear so here is your plan now this is the validation plan this is the key document this is the here is what I'm going to do to validate the process or qualify the equipment or qualify the control system or whatever this is what I'm gonna do this is the key document this is where you want your writers to spend the most time this is what the auditor is gonna look at this is where you're gonna provide all your justification for your sampling and your acceptance criteria and all that stuff once this is done well the protocol will be written to agree with this and the results will be written to agree with the protocol so this is key this kind of tells the total picture here five pieces introduction now remember we're doing this for an auditor we want them to understand what's your name up who gave us the morning talk we want to make that auditor fuzzy okay it's first time I ever heard fuzzy being used as a descriptive word that way but I use the right stuff like product a is a tablet product it's used for the treatment of high blood pressure it's taken three times a day it's a red tablet it's scored I mean real simple kindergarten level stuff but you know that's what the auditor needs to make them feel comfortable okay then we're gonna get into what's the ingredients what's the function of the ingredients what's the process we have a flow diagram on the process meat very elementary and you know when I started doing this I talked to auditors and they told me what we need to understand the product and I said well tell me about that you know and I'd go to meetings with FDA people and I'd ask them questions about this and this is the feedback I would get you know what were good documents so I incorporated that and this was revolutionary in my company because they would never do stuff like that all it's too simple we don't need to do that wrong you know it's only we're talking about a half a page or writing so why not and and I had very good success with acceptability of my protocol so technical information you know a little bit about the product validation strategy what are we doing here you know what's our approach then the validation documentation the listing and I'll show you what I mean by that and then finally the references so now we're talking about the stage 1 documents and he you know technical information from text books anything that is going to be scientific and technical that's going to support your validation you put in the reference section and I wrote a few models and say this is what I want and I know they went through the approval process and everybody was happy with him and that became the standard and this is what I would hand out to people say look make it like this one appropriate for your product but follow this outline so this is your outline from which your model document would be prepared so I wanted to see those five bulleted sections in every validation plan for product for cleaning for for equipment whatever this was the format okay so here's what's in the introduction section okay here's the technical information formula process whatever total validation approach know what do we know from experimental studies what do we know from past data let's for example let's say we had a birth control pill that was the same matrix but it was a little different hormone okay if we have tons of experience with making other birth control pills with the same formula in the same equipment the same process we're gonna mention all that right we're gonna say you know what this is why we're only gonna do one lot of this new product because it's just like all the others and we got a hundred lots of experience and the drug which is only a tenth of a milligram doesn't impact the process validation so that's good enough okay so any information I can put to make my validation stronger is gonna go in this section here of technical aspects and the validation approach and so forth number of Lots what's by risk if I have a low risk I'm gonna do the smallest number of Lots if it's a brand new product they have no experience with where the active drug is a good high percentage of the formula it's gonna be a three lot job and maybe with some post validation extra testing okay you got to evaluate the risk everything we do is risk okay if you're gonna leave with with something in your head from this I mean I hope you have design and understand and demonstrate and then maintain all structured around risk analysis do more when the risk is high do less when the risk is low if you're making an Estero product high risk you're gonna do more if you're putting bottles in a cardboard carton you're gonna do almost nothing okay make sense right okay so here's a little bit more on the plan the details testing and rationale what's the general testing what's the rationale for the test why are we doing these tests what's the sampling why are we sample the way we're sampling all it has it's all connected to risk and I'm going to show you that a little bit later about how we're gonna look at risk and adjust our testing and our sampling appropriately an acceptance criteria how are we going to treat the data we want statistical data treatment if possible a little talk about the acceptance criteria and then remember this is high-level this is the plan the details are going to be in the protocol so the numbers are going to be in the protocol this is the list of documents now this became a just a lifesaver when I went into one job the first thing they said to me is you know you got a big backlog of protocols that aren't closed out and I said well what do you mean well there's about 300 outstanding protocols or packages and they were all a mess so what I started doing in the plan remember we're talking about the plan now is identifying all the things we needed to complete the validation and all those things were identified and they all got a number and so in this case the validation request was number one the drier engineering study to make sure the dryer works that was document two we had to qualify a new dryer that was three a bunch of other stuff then I was able to have a administrative person bug the people who were responsible to get these things done and when all these things were assembled we were able to close the package okay so this was strictly administrative but you see it causes you to think what do I need to get this validation done and remember the validation approval committee is going to approve this whole plan so they're gonna say we agree this will complete the job and what it gets complicated we want a project summary report to kind of put everything together and explain what's in this package all right instead of having seven different protocols and have an auditor say well what did you do here we got a report that says protocol one dryer engineering study to show how it works an event a qualification protocol to qualify it number two a process validation report okay we updated the master plan to include the new information and so there is a document to do that and then a project summary so this is part of that overall let's figure out what we need to do let's think about it let's identify it let's document it everything's got to be clearly identified in the plan and then we're going to work to that plan to complete the whole validation okay and then references and this is where we would put the Rd reports or the references so when we need a report that says the critical process parameters for this product are we're going to reference it here and we're going to say look you are d guys it's going in our plan and the auditors are gonna see that and they might ask to say let me see that report that discusses the critical process parameters or let me see the report that characterizes the validation the compressing process with a factorial design study okay all the stuff from stage one that is relevant to validation you're gonna sorry you're gonna list in the reference section okay so here's how we're connecting stage one with stage two okay so now let's see this is some of the examples of things that we might have as references from Rd so you know scale up report technology transfer reports identification and sources of variation right that was in QbD okay remember the auditors know about QbD they're gonna expect to see all what are your sources of variation in this product I want a report that tells us about that and then how are we controlling it if we say you know a source of variation is our polymer that controls the dissolution rate and how are we controlling it well we're going to have a specification and we're going to limit our our purchases - only one vendor and it's going to be this material and we're gonna have specs and this spec is appropriate to control incoming material that's what I want written from Rd because that is a critical material and one of the things in qbd are the critical material attributes and auditors know about this okay so I'm gonna say to them this is what I want what's your valid your variation control plan okay make sense alright this is where our DS got to help us and they're part of what we're doing okay now you have to look at the original data when you get these reports these R&D guys they're not like I told you they transpose numbers they make mistakes they don't sign things off they record stuff on paper towels they're not like QA people when it comes to data you've got to take a look at that original data cuz an auditor is gonna look at your report and then he's gonna look at the justification for your report which is their report and then he's gonna say oh let me see the raw data that supports their report so they better be prepared to show that raw data in a laboratory notebook or some other system I've had them where they bring out paper towels that are wet out of a garbage can you know really it's unbelievable what kind of laboratory practices people have because they're out of the mainstream I mean QA people never do this kind of stuff I mean you have data sheets you you have the person who enters the data you have somebody verify the data R&D doesn't like that okay but if they're gonna be part of validation they gotta learn documentation practices and you may have to train them