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2 Engineering Essay Examples

Example 1: The Soil Formation Factors Engineering Essay

In this chapter the formation, types and engineering properties of soil are discussed based on literature review .The main emphasis is on laterite soils, the definition, its formation and distribution. The chapter also includes engineering properties of lateritic soils observed and tested previously in various parts of the world. The reason to carryout literature review is to get an idea about lateritic soils and behaviour.

The definition of soil depends upon the field in which it is studied. In Pedology, soil is defined as a material present on the surface, responsible for plant growth. The geologist takes the meaning of soil as the material formed due to past surface activities and actions and present in the thin zone of the Earth’s face in which roots are contained.

In regard to civil engineering, the soil is assemblage of mineral particles which are product of rock weathering. These mineral particles are usually unbounded or weakly bounded. The void areas present between particles contains water or air or both. (Craig, 2004).

Terzaghi and Peck (1948) defined soil as aggregation of mineral grains naturally, that can be detached by lightly mechanical methods as agitation in water.

Hence the soil is mixture of mineral particles, containing void space which may be filled with air or water or both at same time.

The types of soils can be presented in different forms which are shown below:-

There is no specific or particular definition for residual soils, however all the definitions that are in literature do indicate that these soils are formed on site as a result of weathering of rocks and they remain at that same place.(Ahmed, et al. ,2006)

Venkataramaiah(2006) defined residual soils as ‘soils which are formed by weathering of rocks may remain in position at the place of region’ he further stated that theses soils are found at large scale in area where the climate is hot and humid and cause the weathering of rocks easily. The sizes of grains of these soils are not specific and may break into smaller pieces by small amount of load.

Gopal(2000) defined transported soil as ‘Any soil that has been transported from its place of origin by wind, water or ice or any other agency and has been redeposit is called transported soil. He further explained that these soils are more common as compared to residual soils. The particles features such as size, shape, and texture of transported soils depends on source by which they were transported. These soils can further be categorized as alluvial, Lacustrine, Marine, Aeolian and Glacial deposits.

So it can be conclude that soils which remain at the place where they were created from weathering of rocks are known as residual soils and the soils which are moved or blown from there original place of formation by different activities are transported soils.

Soil texture refers to the particle size of each mineral present in soil. It also includes the proportion of each particle size in soil. Based on soil texture, the soils can be divided into three types 1)sand 2)silt and 3) clay.

The particle size for sand is considered to be largest as compared to other types.Most classification systems considers the particle size of sand from 2mm to 0.05mm in diameter. The soils which consists of high proportion of sandy particles is known as sandy soils

Clay consists of particle size lesser then 0.002mm.The soil which contains higher proportion of clay particles is known as clayey.

The particle size for silt is considered to be from 0.05mm to 0.002mm or in some countries it also taken as 0.02mm.However in case of silt the soil containing higher proportion of silt are considered as loamy soils.

The loamy soils are further divided into different types based on proportion of clay, sand and slit particles. Soils with sand and silt particles in higher proportion is called sandy loams or loamy sands. Clayey particles in majority result in sandy clay loam or sandy clay. The soil containing approximately the same quantity of clay, sand and silt particles is considered as clay loam. (Wiekco,2006).

Figure 2.1 Soil classification based on texture

(Wiekco,2006).

The ideal soil consists of 50% solid particles, the solid part may consist of up to 5% of organic matters. The rest of 50% is shared equally among air and water contents which cover 25% each in soil composition.

Water makes up 25% of soil composition in ideal situation. The amount of water can vary based on conditions. In fully dry condition the water content is less as compared to saturated conditions.

Air is 25% of soil composition. Like water the air content also changes depending upon soil condition. For example as it rains the voids in soil filled with air are replaced by water thus reducing the quantity of air or when the soil becomes dry the void filled with water are occupied by air.( Reiley and Shry,2002)

The decaying process of living organisms such as plants and animals in soil results in formation of organic matter. (Bot and Benties,2005).

The organs of dead animals, roots, leaves and wood of plants go through decaying process due to physical and chemical activities due to this decomposition the organic matter is formed.

Fine textured soils such as clay contain higher content of organic matter as compared to coarse textured soil such as sandy soils.( Bot and Benties,2005 citied Prasad and Power, 1997).

Studies on the effect of organic content on certain properties have been carried out. Malkawi, et al. (1999) observed increase in the plastic limit and the liquid limit , the optimum water content of the illitic soil with increase in organic content and decrease maximum dry density.

The solid components of soils consist of crystalline material called minerals. Mineral particles are categorized based on their structure and chemical composition. Oxygen and silicon minerals are most significant to geo- technical engineers. Fine grained soils consist of mineral particles which are platy in nature. (Budhu,2007).

Figure 2.2 Soil composition

(Reiley and Shry,2002)

Soil is not a singled phase substance but a multi phase.

Soil is a particulate material and not coherent like concrete and steel. Naturally soil, comprises of three main components that are solid particles along with water and air present in the voids which occur among the particles. The water and air proportion in soil depend on location and environmental and climatic conditions. (Singh,n.d.)

Criag (2004) describing phase relations suggest that soil may have double or triple phase composition. Relating the degree of saturation and composition of soil he further explains that a fully dry or unsaturated soil composes of two phases that are solid particles and pore air. A completely saturated also like fully dry soil is two phase but has pore water instead of pore air.

A third category he describes is the partially saturated soil which is three phase comprising solid soil particles, pore water and pore air.

Figure 2.3 Phases of soil

(Singh,n.d.)

Atterberg was a Swedish soil physicist who in (1911) introduced a classification system and technique to establish the states of consistency of soil. The consistency states are liquid when the soil is wet, plastic state and ultimately the dry solid. The principle on which this method is based is to find the water content using the relation (mass of water/dry mass of soil) at particular transition point between different consistency states. The terms plastic limit, liquid limit and shrinkage limit which as a whole known as Atterberg limits were used to defined theses transitions points.

Factors effecting Atterberg limits:-

Particle size.

Particular surface area of particles that can be occupied by water .

Particle size distribution. (Lal,2005)

Sawangsuriya and Fratta(2006) indicated that index soil properties generally used for classification, description and identification of fine grained soils are called atterberg limits. Actually these index properties refer to water content, it is an indication that at a certain amount of water content the soil will flow as fluid, it will be plastic in nature or semi solid.

Dolinar, et al. (2007) stated that the consistency of a fine-grained soil varies from a semi-solid state to a plastic state and ultimately to a liquid state with an increase in water content.

He defined plastic, liquid limits as follows:-

The point at which the consistency, due to the soil water content, is altered from a semi-solid state to a plastic state is known as plastic limit. It is denoted by (PL).

The point upon which the consistency is changed from a plastic state to a liquid state is called liquid limit. It is denoted by (LL).

These limits are also known as consistency limit.

The water content upon which the soil is transformed from the semi solid state to the solid state is called shrinkage limit. The soils no more is saturated below the shrinkage limit .The voids of soils are filled with air .Moreover the volume of the soil does not alter due to capillary tension. Hence the soils maintain constant volume and stops shrinking further for water content at shrinkage limit. The water content at shrinkage limit is the lowest at which soil can remain fully saturated. (Arora, 2008).

Water content between liquid and plastic limit is known as index of plasticity. It is denoted ( Ip). It is calculated by formula

IP= (LL-PL)

Where LL is liquid limit and PL is plastic limit. It shows the mechanical behaviour of soil towards changing amount of water (Lal, 2005).

Arora(2009) defined index of plasticity as’ numerical difference between liquid limit and plastic limit’. It may also be denoted by (PI).

Volume

Plastic state Liquid state

Solid state semi solid

State

SL PL LL

Water Content

Figure 2.4 Different states of soil.

(Arora, 2008).

Specific gravity is defined as the ratio of weight of soil solid composition to the weight of water with the same volume.(Yalcin,2007). The values of specific gravity of soil generally vary from 2.60 to 2.84.(Abdullahi,2006). It is denoted by symbol Gs.

Reddy and Sastri(2002) state that ‘unconfined compressive strength is defined as the ratio of axial failure load to cross sectional area of the soil sample when it is not subjected to any lateral pressure’.

Where

qu = Unconfined compressive strength

P= axial load at failure

Ac= corrected area at failure =Ao/ (1 -)

Ao= intial cross sectional area

= axial strain in sample L / Lo

L= change in length of sample

Lo=initial length of sample

Table 2.1 Unconfined compressive strength related to consistency

Consistency

Unconfined Compressive strenght

kPa

Very soft

<25

Soft

25–50

Medium stiff

50–100

Stiff

100–200

Very stiff

200–400

Hard

>400

Source (serajuddin and chowdhury,1996)

Particle size distribution gives the amount of different particles size present in particular soil. It is usually determine by sieve analysis. The particle-size distribution of soil provides the mean particle size and fines content which help in soil classifications and establishing soil property relationships (Vipulanandan and Ozgurel, 2009)

As the name indicates California bearing ratio is bearing capacity of soil. California bearing ratio value is an important parameter when designing a sub grade or base for roads. The potential strength of sub grade material is indicated California Bearing Ratio (CBR) and is a vital index to assess its performance in expressway.( Guang-qing, et al. ,2006).

For a soil mass a shear strength is a internal resistance per unit area that a soil mass can provide to oppose failure and sliding along the any plane within it .

The Mohr-coulomb failure criteria is fundamental equation to represent the shear strength of soil.

c +

Where

C = cohesion

=Angle of Internal friction.

The basic approximation in above equation is that shear stress is linear function of normal stress at failure plane.

For saturated soil the sum of effective stress and pore water pressure gives total normal at any particular point.

( Das,2008).

The Mohr-Coulomb failure criteria equation in terms of effective strength parameters is given as

τ=c′+ (σ−u) tan φ’

τ=c′ +σ’ tan φ’

′where

τ i= the shear strength,

c′ = effective cohesion,

σ = total stress,

u = pore water pressure

φ′ = effective angle of internal friction or shearing resistance. (Zhang, et al., 2001)

Figure 2.5 Typical shear strength diagram

(yilmaz and Erzin,2004).

There are two shear strength parameters

Angle of internal friction.

Cohesion

The angle of contact between the particles of soil or unconsolidated mass and the underlying surface is called angle of internal friction. It is also known as angle of shearing resistance. It is denoted by φ(phi).It is also regarded as slope angle

The level to which particles or grains of soil are bounded together is denoted by cohesion or the ability of soil particles to adhere with each other is known as cohesion. (Huggett,2007).

Dry density, particle size distribution, particle shape, texture of surface and water content are the factors on which angle of internal friction is dependent where as the size of clayey particles, clay minerals types, valence or chemical bonds among particles, water content, and percentage of the clay are the factors on which cohesion is based.( Jain, et al.,2010).

Site investigation is a significant element in construction industry and should be given due importance. One of the objectives of site investigation is to determine the ground conditions and type of soil lying on site of construction. The engineers should know the engineering properties of soil on basis on which they are going to design the foundations or any other structure. They can also suggest some solution for the properties of soils which do not meet requirements such as stabilization or addition of admixtures etc.

Some of major objectives of site investigation as mentioned in BS-5930:1999+A2:2010 are as follows:-

Design

The site investigation can assist in creation of design which is economical and satisfying and safe, the results of investigation can help in planning the temporary works need for construction process.

Site selection

The civil engineers can propose more appropriate and up to standard site for construction if option is available. Moreover they can advise suitable area for construction a particular site.

Construction

To predict the preferred method of construction and to know the problems that may arise during construction such as delaying due to conditions of ground or water table etc.

Effect of change

The results obtained from site investigations can help in determining the changes that can take place due to natural factors or as result of construction works and their effect on environment.

. Oloufa,et.al(1994) while highlighting the importance of site investigation stated that It is key feature to estimate and plan new construction projects. Site investigation gives indication about ground characteristics as well as underground conditions .These conditions in return allow engineers to make a choice of suitable construction methods and machinery. These factors affect the schedule and costing of projects.

Hence the site characteristics should be observed carefully.

The soil formation process involves the weathering of rocks. The weathering causes decomposition and disintegration of rocks and minerals into smaller and smaller particles. This weathering is caused due to natural or mechanical and chemical agents.

The mechanical weathering disintegrates the rock to soil, but soil retains most properties similar to rock material from which it was formed. The mechanical weathering agents include water, wind and glaciers etc.

The effect chemical weathering is intense as compared to mechanical weathering. The soils minerals are partially or completely vanish in relation to rock materials they are formed from. Chemical weathering occurs at higher rate in tropical and humid climatic conditions. (Venkatramaiah, 2006).

Soils are formed as result of five factors which are climate, organisms (biota) topography, parent material, and time. The soil formation is generally shown by Jenny’s state factor equation that is S=f(C, O, R, P, T.) here (R) stands for relief depicting topography factor. (Demas, et al., 2001).

Climate refers the general climate conditions of the region where soil exists .The climate includes amount rainfall, moisture in air, temperature. The organism means the plants, animals and microorganisms that react with soil. Topography refers landscape, terrain or geological features of location of soil deposit.

By parent material it means the original hard rock deposits where the soils are formed. For example, till is a parent material for soil created in glacial deposits similarly alluvium is a parent material for soil produced at the side of a river. Parent material influences the grain texture and mineral composition of soil,

Time depicts the duration of soil forming process. It shows that for how long chemical or mechanical weathering has taken place on rock or age of existing soil deposit. (Brevik, 1999)

Topographical characteristics such as curves, slope, steepness and other landforms affect the hydrological conditions of area where soil deposits are located and cause diverse soil moisture conditions and flow trends. Different types of slopes yield different conditions of drainage.( Seibert, et al.,2007).

Climatic conditions effect soil formation. For instance in tropical, hot and humid conditions the high temperature and humidity speed up weathering of rock and soil profiles with large depth are formed.(Noguchi et al,2005).

Group Classification

A-1

A-3

A-2

A-4

A-5

A-6

A-7

A-1-a

A-1-b

A-2–4

A-2–5

A-2–6

A-2–7

A-7–5 A-7–6

Sieve Analysis, % passing

2.00 mm (№10)

50 max

0.425 (№40)

30 max

50 max

51 min

0.075 (№200)

15 max

25 max

10 max

35 max

36 min

Characteristics of fraction passing 0.425 mm (№40)

Liquid Limit

40 max

41 min

40 max

41 min

40 max

41 min

40 max

41 min

Plasticity Index

6 max

N.P.

10 max

11 min

10 max

11 min

Usual types of significant constituent materials

stone fragments, gravel and sand

fine sand

silty or clayey gravel and sand

silty soils

clayey soils

General rating as a subgrade

excellent to good

fair to poor

Source (Ranjan and Rao,2005).

Example 2: An Overview Of Quality By Design Engineering Essay

Since there is immense competition globally and growing impact of Information technology, the pharmaceutical industry should need to improve its performance. The industry should implement newer technologies that can effectively reduce cost of production and at the same time improves product quality and regulatory compliance. Quality by Design is a newer approach that has been offered by the United States Food and Drug Administration (USFDA) which if understood well and implemented properly can save considerable amount of time and cost and at the same time can improve final product quality and regulatory compliance which can increase the speed of product to reach in to the market. This article discusses the background of quality by design concept, Building blocks of Quality by Design, and its approach across the product life span and benefits that it offers.

In 2002, the U.S. Food and Drug Administration (FDA) published a guidance document for pharmaceutical companies on cGMP for the 21st century. This guidance document expressed a strong desire that companies should build quality, safety and efficacy in to their product. This concept is now known as Quality by Design (QbD).

Till now, the meaning, benefits and impact of quality by design is confusing to many people. Some says that it is a newer way to develop drugs, biologics and devices; some says that it can shorten the production cycle; some says that it provides more business flexibility but no one knows what it is exactly. Some people do not even know that where, when and how should it be applied? Initially there are so many companies who tried to adopt Quality by Design concept but confusion gave way to frustration.

Quality by design (QbD) is the concept first developed by the famous quality expert named Joseph M. Juran in his 1992 book called “The New Steps for Planning Quality in to Goods and Services”. He believed that quality could be planned in the very first stage of the production rather than final testing. The concept was first used in automobile industry. There is one article published in June 2007 titled “Elucidation: Lessons from the Auto Industry” says that Toyota Automobiles was the first company who implemented many Quality by Design concept to improve their automobiles in 1970s. That is why we can say that Quality by Design concept is new only for FDA regulated industries and not for other industries like technology, aeronautics, telecommunications etc. In other words, we can say that the computer we use, the phone we answer, the airplane we ride, the car we drive and the camera we use are all products of Quality by Design but we cannot say that whatever tablet we ingest and whatever biologics we use are the products of Quality by Design.

In 1990s, many of the medical device manufacturing company has implemented Quality by Design aspect which resulted in reduced risk and manufacturing cost and at the same time increased patient safety and product efficacy. From the success of QbD aspect in medical device manufacturing, the FDA officials felt that this concept has to be applied to drugs and biologics also. So, the internal discussion in FDA started in late 1990s and finally they published a concept paper in 2002 on cGMP in 21st century. With the huge help of some pharmaceutical companies, pilot programs were started to share the Quality by Design application and process understanding with the other companies.

“The FDA publication defined Quality by Design as:

But still it is one of the most misunderstood and misused tools available to many pharmaceuticals as well as Medical devices company because FDA has just published the paper along with its definition which clarifies FDA’s approach, it left far too many questions unanswered. The companies were left to implement Quality by Design concept on its own. John Avellanet, a consultant from cerulean associations LLC says that “when Quality by Design is planned and implemented properly, the benefits are enormous. But if Quality by Design is tackled haphazardly, the benefits fizzle.”

Quality in pharmaceuticals is very much important since it directly deals with patient’s health and so Food and Drug Administration (FDA) has set stringent law for drug approval. It is a U.S. agency that has power to approve or reject the drug product, biological or medical devices in order to set the Americans free from risk. Along with the dosage forms, it is also concerned about the drug development process e.g. how it is manufactured and purity of the condition under which it is manufactured.

In order to produce quality product consistently, FDA suggests the pharmaceutical Industries to implement Quality by Design (QbD) concept. Pharmaceutical QbD is FDA’s one of

the two systemic, holistic and risk based approach to pharmaceutical development. The other one is PAT (Process Analytical Technology). If QbD explains “what to do,” then PAT is a framework for “how to do”.

QbD is overarching philosophy articulated in both the cGMP regulations and in robust modern quality system. The principle of QbD is “Quality should be built in design”, the testing alone cannot give surety on product quality.

It means that designing the whole drug development and manufacturing process in such a way that produces product with pre defined quality objective. QbD identifies characteristics that are critical to quality from the perspective of patients, translates them into the attributes that the drug product should possess, and establishes how the critical process parameters can be varied to consistently produce a drug product with the desired characteristics[2]. In order to achieve this, the relationships between the formulations and manufacturing process variables and product characteristics are thoroughly understood and source of variability should be identified.

This knowledge and skills are then used to implement flexible and robust manufacturing process that can adapt and produce consistent quality product over a period of time[2]. Thus some of the important QbD features include:

Quality by testing is the approach that most of the pharmaceutical organizations are using currently. Some of the companies has replaced QbT concept to QbD to produce a quality product consistently. In Quality by Testing, the final product is tested to get assurance that particular batch product is within the specification and is of highest standard quality.

The recent approach is QbT where if drug substance and excipients meet the specification the next step of unit operation is carried out such as Mixing, blending, drying, compression, coating etc. with fixed process parameters. If the materials do not meet the In Process Specifications then the material is discarded. If it passes, then an assay is performed where the %

of purity, Dissolution, Disintegration, Moisture content is measured. In those cases, the acceptance criteria based on one or more of the batch data.

Finally, if product fails to meet the finished product specification requirement, it is discarded. This is how pharmaceuticals are manufactured using QbT approach.

In Quality by Design, Consistency in quality product manufacturing comes from the designed and control of the process. The next step is not performed until the step before that gets pass. If the first step fails then the root cause of the failure is investigated and understood to fix it in order to move on to subsequent steps.

The first step to implement Quality by Design is to understand critical output of QbD and after that identify critical building blocks of QbD such as improving process understanding and risk associated with it.

The output of process control, design space and risk are consistent with this approach. The building blocks needs to be assembled as mentioned below before results can be realized.

New drug development stage is riskiest and costliest stage of the drug and biologic life span. If Quality by Design concept is well understood and well applied, it provides most powerful results such as reducing time, cost, risk and efforts. John Avellanet said that “Quality by Design is a strategic and systemic approach to get the new product pipeline to market faster, easier and for less.”

Preclinical:

Quality by Design improves product development if we use our prior knowledge from the previous experience, previous product or from literature surveys. We can identify and specify the characteristics that our new product must possess from the previous experience and customer needs.

Nonclinical:

To meet the pre determined specifications, a company must conduct preclinical as well as nonclinical experiment to verify the ability of the product being developed to meet the targets. In other words, a company should carry out in vivo and in vitro tests and depending on the product; the amount of active molecule in serum has been drawn from the feasibility experiment.

Clinical:

The clinical studies are confirmatory if we apply Quality by Design concept during drug development. A company can use the traditional approach to the clinical trials or try adaptive trial. During the drug development process, when the product reaches to the phase III trial stage a company must focus only on the micro refinements to their process as well as their manufacturing process.

Scale-UP:

The scale-up is defined as conversion of an industrial process from a pilot plant or a small laboratory set up to a large commercial manufacturing. It is also a part of Quality by Design. Application of QbD during scale up allows us to document changes and rationale during conversion from pilot plant manufacturing to full scale manufacturing.

For example, imagine that Stevens Pharmaceuticals limited is actively engaged in chlorpromazine tablet manufacturing. The pilot model was successful. Now the company wants to switch the pilot model to a large commercial manufacturing. During the coating of the tablet the company need increased nozzle size on a sprayer so that they can meet the higher spray rate for faster manufacturing. As long as the larger nozzle size maintained the

same droplet size as in pilot production, then no further testing and validation would be required. Such information is then documented and attached in the final submission for market approval.

Submissions for market approval:

“Submissions based on QbD have more scientific information on product, process and controls which allows faster reviews” According to FDA’s own internal analysis, Quality by Design based applications are processed 63% faster than traditional submissions[3].

When Quality by Design concept applied to drugs and biologics manufacturing, it offers more business flexibility. Once upon a time, it was quite a bit difficult for the companies if they want to modify their manufacturing process. In those cases, they have to wait for the regulatory approval prior to implementing changes. But now, under QbD, this review can be eliminated by relying on design space, Process Analytical Technology and ‘Real Time’ quality control.

Design Space:

Product manufacturing processes that do not impact final product quality, its safety and efficacy are called “design space” As per the ICH guidelines the design space is “the multi dimensional combination and interaction of input variables (e.g. material attributes) and process parameters that have been demonstrated to provide assurance of quality”. “Design Space consists of the set of all values and combination of the controllable factors that are predicted to yield all of the output quality attributes within their allowable ranges with a sufficient high level of assurance”[4].

Knowledge Space

Movement within design space does not considered a change and so it does not require regulatory review but movement out of the design space is considered change and requires regulatory review or approval. The more we know about the impact of the process on the product’s final quality and safety, the more flexibility a company can have under quality by design.

Process Analytical Technology (PAT):

It is very difficult to predict the effect of process change on final product. An essential part of quality by design accepts that even if the effect of process change cannot be predicted, it can be fully monitored and controlled. Process analytical technology allows us to continuously monitor, test, analyze and adjust whole manufacturing process to increase control and improve efficiency through the measurement of critical process parameters (CPP) which affects critical quality attributes (CQA).

“REAL-TIME” Quality Control:

The third aspect of Quality by Design in the manufacturing arena is the ability to shift quality control upstream in to production. By this way we can reduces the waste and the cost of producing a batch that ultimately fail the quality control. By embedding quality control checks throughout manufacturing process, Quality by Design allows us to increase our production, improve our product and streamline the whole process.

Embedding quality control checks throughout manufacturing process is one of the control strategies that helps ensure production quality. We all know that Quality by Design is simply designing and developing the product and manufacturing process in order to get predefined product quality, safety and efficacy. If we link the product design and development stage directly with process development then it gives us the degree of control required.

Continuous improvement:

If we remember back on the definition of Quality by Design as “everything we do to directly promote and prove safety, efficacy and quality of our product,” then continuous improvement is a part of promoting and proving safety, efficacy and quality of our product. By continuous improvement, we can focus on making the whole manufacturing process efficient without negatively impacting the product. Since QbD facilitates continuous improvement in product quality it increases the regulatory flexibility.

Product Performance:

Key to successful implementation of Quality by Design is to identify Critical Process Parameters (CPP) and Critical Quality Attributes (CQA) that are critical to safety, efficacy and Quality of the product. If we can prove that drug excipients like food color or sweetening agent has no impact on safety, efficacy and quality of final drug product then we can decide not to bother about testing of those materials. Similarly, those processes that have no impact on product safety, efficacy and quality can also receive minimal attention, testing and control. This undoubtedly reduces the costs involved in product development and its production.

Benefits of Quality by Design:

After fully implementation of QbD, one can get assurance that all the critical sources of process variability have been identified, measured and understood so that they can be controlled by the manufacturing process itself. That is why the benefits of QbD are significant. Such as,

These benefits translate in to significant reduction in capital requirement, resource cost and time to value. That is why it is said that it is most misunderstood and misused tools available to pharmaceutical industry but if understood thoroughly and implemented properly, the benefits are enormous.

Pharmaceutical quality by design is a systemic approach to the pharmaceutical development which begins with predefined quality objectives. QbD is about using correct tool for specific job. It is a mind set and not a process. QbD works for any process and does not require a ‘project’. The only reason why most organization are still thinking about QbD rather than implementing is “Too many other things to do”. But if understood and implemented well then it enhances and modernize the regulation of pharmaceutical manufacturing and product quality at the same time offers immense benefits. The results shows that companies who adopt QbD can expect significantly reduced risk of costly deviation and rejects. It also reduces the time required by the FDA to review the NDA submissions 63 % faster. Since it is a FDA’s 21st century’s risk based approach, any company if understand and implement QbD correctly can build five star quality product and make FDA happy.

“If a screw is loose — — Tight it — — Don’t rebuild the whole house!”

[1] IBM Business Consulting Services (2005). Transforming industrialization: A new paradigm

for pharmaceutical development.(Accessed November16, 2006). Retrieved from

[2] Lawrence X, Yu. (April 2008). Pharmaceutical quality by design: product and

process development, understanding, and control.Pharmaceutical Research,

Vol.25, P.g 783.

[3] Snee, Ronald. (2009, October 09). Building a framework for quality by design.

Pharmaceutical Technology, 33 (10),

[4] Watmough, Peter, & Morris, Laura. (2009, September 17). Implementation of

quality by design in new product development. Retrieved from

[5] Avellanet, John. (2008, March). Why Quality by design? an executive’s guide to

the fda’s quality by design. Retrieved from

[6] Neway, Justin. (2007). Achieving manufacturing process excellence with quality

by design, design space development, design of manufacturing and pat.

[9] A change of course for pharmaceutical manufacturing.

[10]Quality by Design is breathing new life into quality systems and process analytical technology.

[11] Discoverant enables quality by Design.

[12] A change of course for pharmaceutical manufacturing.

Why giving up is the BEST thing you can do.

2 Engineering Essay Examples

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