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TPP Vs QTPP #Quality by Design-Part 3 — Transcript

by Simplify Pharma · 2,489 words · 431 segments · language en · Watch on YouTube

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0:01Welcome to Simplify Pharma.
0:03In this lecture, we will discuss the
0:06first step of quality by design
0:08and difference between TPP and QTPP.
0:12In pharmacy, it is very essential for a
0:15student to understand the concepts and
0:18more than that it is essential to apply
0:20them.
0:21Therefore, I have introduced something
0:23interesting in this video. That is
0:25concepts are explained with the help of
0:27case studies that will allow us to
0:29students to learn application of the
0:32concepts that we are learning.
0:34Please do like and subscribe to my
0:37channel
0:38and press the bell icon to get the new
0:40video updates.
0:45Now, coming to the QBD, the very first
0:48step that we saw in our last video, it
0:50was to define product profile
0:53which constitutes of two, that is TPP
0:56and QTPP.
0:58TPP means target product profile and
1:02QTPP means quality target product
1:05profile. So, the very first step of QBD
1:08is to define product profile. Now, let's
1:11see what is TPP, that is target product
1:15profile.
1:16Now, target product profile, it is a key
1:19document
1:20which provides information to the Food
1:23and Drug Administration about a drug
1:26development process.
1:28One thing we all need to understand, the
1:31entire QBD process that we are doing but
1:35QBD is nothing but a document, a
1:38document that we submit to the FDA.
1:41And that documents, it gives information
1:44regarding the drug development process.
1:46So, this entire QBD process is about
1:49documentation.
1:51And we can say thus this TPP it's a
1:56planning tool in drug development. It's
1:58a planning tool that we use in drug
2:00development. So, what is the purpose of
2:02TPP?
2:03The purpose of TPP is to ensure that the
2:07drug development process of the
2:09manufacturer, it is efficient and it
2:12provides all the required relevant
2:15medical, technical, and scientific
2:18information for evaluating the
2:20commercial outcome of a drug.
2:24So, this is what TPP is. Now, you can
2:28imagine when you're developing a drug,
2:31you need a guideline to help you
2:33understand what you are aiming for.
2:36As I gave previous example, it's like
2:39working in a laboratory.
2:41Now, in order to make any product in a
2:44lab, obviously before starting the
2:46experiment, the teacher provides you
2:49with the aim, objective, materials,
2:51chemicals that are required, procedure
2:53that we are going to follow and the
2:55calculation that we are going to do.
2:57What is all that? That is the profile
3:00that is being given to you.
3:02So, in the similar manner, if you want
3:04to manufacture any new product you need
3:07to have a product profile.
3:09Now, why are we calling it as a target
3:12product profile?
3:13First of all, let's see the definition
3:15of TPP.
3:17A prospective summary of the quality
3:20characteristics of drug product that
3:23ideally will be achieved
3:25to ensure the desired quality
3:28taking into account safety and efficacy
3:30of the drug product.
3:34So, when I said T when you're developing
3:36a drug, you need a guideline that helps
3:39you to understand what you are aiming
3:41for.
3:43So, once we know that guideline and once
3:46we know what we are aiming for
3:49then we can also determine what will be
3:51the end results
3:52that I want to see in my drug or that I
3:55want to see in my product. So, TPP, it
3:58helps to define what those end goals
4:01are.
4:02So, it is a tool that outlines the
4:05desired profile or characteristics of a
4:08product.
4:09Jab hum kuch banana chahte hain, any
4:12product that we want to manufacture
4:14before manufacturing that product, we
4:16need a guideline. What are we
4:19manufacturing?
4:20For what disease are we manufacturing?
4:22What is the target population?
4:25And how are we going to manufacture it?
4:28Will it show the results which it is you
4:30don't which it should show.
4:33So, all this profile, it comes under
4:36target product profile.
4:38So, it includes dosage form, route of
4:41administration,
4:43dosage strength, pharmacokinetic,
4:45stability
4:48starting from usage information,
4:49indication
4:51and then adverse reaction
4:53information about overdosing
4:56description of various aspects of the
4:57drug clinical pharmacology, toxicology
5:01study, clinical studies, the references
5:03that were used, then storage and
5:06handling condition, information even
5:08about patient counseling.
5:10Anything and everything related to the
5:13drug or related to the product that we
5:15want to manufacture
5:17is included in target product profile.
5:21So, this TPP is patient and labeling
5:25centered concept.
5:26When we say patient and labeling
5:28centered concept, what does it mean?
5:31It can identify desired performance
5:34characteristics of the product.
5:36See, in order to manufacture any new
5:39product, first of all
5:41the thing that should come into your
5:42mind is the disease that you want to
5:45target.
5:46I want to manufacture
5:48a product that targets cancer. I want to
5:51manufacture anti-cancer product. I want
5:54to manufacture product, for example, uh
5:57that targets
5:59migraine. So, I want to manufacture
6:01anti-migraine product. So, this is how
6:04we come up with the aim or objective.
6:07So, as per that, we have to identify the
6:09desired performance characteristics of
6:11the product.
6:13And that should be related to the
6:15patient's need.
6:16That's why the very first thing that we
6:18have to keep in mind, what do the
6:20patient require?
6:22The patient require a sustained release
6:23dosage form, whether the patient require
6:25immediate release dosage form.
6:28How you know, we have to take into
6:29consideration the patient compliance.
6:32And it is organized according to the key
6:35section in the drug labeling.
6:38So, first thing we have to keep in mind,
6:41the patient requirement and second thing
6:43that we have to keep in mind, how the
6:45entire target product profile is
6:47organized. Main thing keeping in mind
6:49the drug labeling.
6:52So, that's why it is patient and
6:55labeling centered.
6:57So, in target product profile, first of
6:59all, you have to identify the target.
7:02How do we do that?
7:04That is we have to define what are the
7:06patient needs and as per that we have to
7:10design the drug labeling.
7:12So, first we have to identify the
7:14target, then we have to design it and
7:16then we have to implement it.
7:19Uh let's see a bit more in detail.
7:23When I say we have to identify the
7:24target, that is depending upon the
7:27patient need, the labeled use taking
7:30into consideration the safety and
7:32efficacy of the product, you will
7:34identify the target.
7:36So, that will be like defining the
7:38target product prof- profile or maybe we
7:42can also call it as a QTPP, quality
7:45target product profile.
7:47Then we have to design it. That's why
7:50come into the picture the design
7:52formulation and the design process.
7:55And this is the reason we identify CMA
7:57and CPP, critical material attributes
8:01critical process parameters.
8:03And then when we have to implement it,
8:05how are we going to implement it? By
8:07establishing the control strategy.
8:11And then we monitor and update the
8:13process. This is like a continuous
8:16process.
8:17So, we can also summarize by saying what
8:20is TPP? It outlines a desired profile or
8:24characteristics of a product.
8:26It also summarizes the drug development
8:29program in terms of labeling concept.
8:33So, what do you ultimately want to see
8:35in your drug label?
8:37It's also useful document because it is
8:40shared with appropriate FDA staff
8:42and other regulatory agency staff.
8:45This also allows us to facilitate the
8:48communication between
8:50the pharmaceutical industry and
8:51regulatory staff and also amongst the
8:55you know, people those are working in
8:57the pharmaceutical industry. It is also
8:59helpful for them.
9:01So, in a way you can say, you know,
9:03there's back and forth communication
9:05between the drug development program,
9:08all the people those are involved in the
9:09drug development program.
9:12In this way, the regulatory agency can
9:15actually kind of take a glimpse into the
9:17program to see what your end goals are
9:19and if they think there is something
9:22that needs a change, they can even
9:23comment on that.
9:25Now, this TPP is completely voluntary
9:27process and also it is dynamic.
9:31It's going to keep changing over time
9:34because as and when you get new
9:36information about the product, you have
9:37to keep adding into the TPP.
9:41Because it happens over a period of
9:43time, you will keep getting some or the
9:44other information regarding your product
9:46or the drug.
9:48The more information you have, the more
9:50your program might change. That is also
9:53a thing.
9:54The FDA has published guidelines that I
9:57have shown here for industry and it
10:00outlines what they would like to see in
10:02a target product profile.
10:04It is a good tool for drug developers to
10:06use when they're first putting together
10:08their TPP. This I have pulled from the
10:10internet. As you can see, this is the
10:13published guidelines by the FDA if you
10:16have to draft your TPP.
10:19So, the benefits of TPP.
10:21There are many benefits to having a TPP
10:24during a drug development process.
10:27The first benefit is it ensures the
10:29appropriate safety and efficacy data
10:32that are generated in order to make
10:34claims that you want to make.
10:36So, it's important to really outline in
10:39the beginning of your drug development
10:41program what safety and efficacy data
10:44you need to generate.
10:46It also identifies possible gaps in the
10:48drug development program. So, you can
10:50imagine that if you're outlining what
10:53data you want to collect, what
10:55information you want to see, or what
10:57goal you want to hit,
11:00it can really highlight some of the gaps
11:02that you might have.
11:04And it also helps prioritize resources.
11:08You use a lot of resources in terms of
11:10money and manpower in a drug development
11:12program. So, it is very very essential
11:15to prioritize those resources. We can
11:17save lots and lots of money and time and
11:19also manpower.
11:22So, having that outlined in TPP, it can
11:24be very helpful.
11:26It can minimize the risk of late-stage
11:29drug development failure.
11:32And I think part of this has to do with
11:35it, you know, really outlining what data
11:38we need to collect and what are our end
11:41goals. Once we outline that concept,
11:44obviously, the risk of failures will
11:46reduce.
11:48Then, it helps in communication with the
11:51regulatory team,
11:52with the industry, and also within the
11:54industry different departments. It helps
11:57them communicate.
12:00Uh
12:01a TPP must be reviewed and updated
12:03periodically as and when the new
12:05information is available.
12:08So, we cannot say we have one target.
12:10It's like a moving target because the
12:13new information will keep pouring and we
12:15will have to add it to the TPP.
12:18Especially when there are times of
12:20really rapid and fast-paced drug
12:22development.
12:23In that case, you know, it's okay. Most
12:25of the drug development teams, they do
12:27periodic review of the TPP every 6
12:30month, every 12 month, just to make sure
12:32everything in TPP is up to date and
12:36relevant.
12:38Now, coming to the next concept, that is
12:40quality target product profile.
12:44It is a set of elements that defines a
12:46drug product, same as TPP.
12:49A target or goal is set in advance,
12:51again same as TPP.
12:53It is a guide to drug development
12:55process program, again as TPP.
12:58So, we can say it is a tool for setting
13:00strategy for the drug development taking
13:02into consideration safety and efficacy
13:04of the product. So, up till now
13:07everything is similar between TPP and
13:09QTPP. Then,
13:10where does the difference lie?
13:13B is identification of those attributes
13:16that are critical to the quality of the
13:18drug product.
13:20Taking into consideration intended usage
13:23and route of administration.
13:26So, TPP indicates what a drug will do. A
13:29QTPP indicates the quality targets
13:32necessary to do it.
13:35You know, there is somewhere in the
13:37literature you will find there is
13:38overlap between TPP and QTPP. But, we
13:41have to understand what is the main
13:42difference between both.
13:44And this table will help you
13:47identify the main difference. As you can
13:49see, in target product profile, it
13:51contains all the information related to
13:54the drug, even storage, handling
13:56condition, the patient counseling,
13:59everything about the drug. Whereas QTPP,
14:03it contains only data that can affect
14:05the quality of the product.
14:08So, that's a difference. If, for
14:10example, this is like A to Z
14:13of the product, and this is just few
14:15alphabets of the product that can affect
14:17the quality of the product.
14:20So, these two documents, they are
14:21routinely used during development.
14:24However, it's very important to keep in
14:25mind that TPP focuses on the overall
14:29program needs.
14:30So, it constitutes of the entire
14:33program. Whereas QTPP, it focuses on the
14:36actual drug product itself.
14:39Example of QTPP for the topical product.
14:43This is a case study that we are taking.
14:45This is how a QTPP look like. As I told
14:47you, this entire QBD process is
14:49documentation. So, when we talk about
14:51TPP, QTPP, obviously, these are also
14:54documents. So, this is how a QTPP
14:57document is made.
14:58It will constitute of drug product
15:00quality attributes. All these attributes
15:03that can affect the quality of the drug,
15:06they are written.
15:08Then, the target,
15:09whether they are critical or not, and
15:11you have to justify the criticality.
15:15Let's understand it further by taking
15:18one more case study.
15:20This is one more research paper that I
15:22have pulled from the internet in which
15:24the author has tried to optimize a
15:27micellar-based in situ gelling system
15:30using QBD approach.
15:32So,
15:33uh this main
15:35in situ gelling system is used for
15:38ocular infection, fungal ocular
15:40infection.
15:42As you can see over here,
15:44this is how a QTPP was made for the
15:48particular
15:49product.
15:50So, the route of administration was
15:52ocular
15:53because the topical application to the
15:55targeted tissue. This is a
15:56justification.
15:58Then, the next factor, delivery system,
15:59micellar-based in situ gel. What is the
16:01justification? Increase the contact time
16:04of drug delivery system with ocular
16:06tissue. In the similar manner,
16:08all the important characteristics that
16:11can affect the quality of the product,
16:13they are considered over here. What is
16:16the target and what is the
16:18justification. So, this is how a QTPP
16:21sheet looks like.
16:24This is one more case study that I have
16:26pulled from the internet.
16:28It constitutes of QTPP sheet for a
16:30generic escitalopram tablet 20 mg. As we
16:34can see, the dosage form, target,
16:37justification, like this all the
16:39important characteristics that can
16:41affect the quality of the product that
16:42are mentioned over here,
16:44and the target, and as per that the
16:47justification is mentioned. So, this is
16:49how a QTPP sheet looks like. So, this
16:53was all that was in this video,
16:55difference between TPP and QTPP. I hope
16:58you have understood the concept with the
17:01help of all these case studies. I hope
17:03these case studies have been really
17:05helpful.
17:06And in the next part of the video, I'll
17:08be coming with the step two of QBD, that
17:11is CQA, critical quality attributes. So,
17:15do subscribe to my channel to stay
17:17updated with the latest video that I
17:19keep on uploading. Thank you.

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