A)
a)
Value of K is calculated as follows
From the given problem,
Taguchi loss function can be calculated by using following formulae,
The Taguchi Loss Function is: L(x) = k (x – T)2
$75 = k (0.02)2
k = 75/0.0004 = 1,87,500
\ L(x) = k (x – T)2 = 187500 (x – T)2
b)
Loss function is referred to as Taguchi loss and based on K value obtained from above the loss value is calculated below.
L(x) = 187500 (x – T)2
\ L(0.01) = 187500 (0.01)2
= $ 18.75
B)
Quality management is considered as critical aspect in pharmaceutical industry and companies across the globe together are involved in harmonization of guides and practices and also associated with launching goods that are approved by Food and Drug administration. There is increase in demand specifically in21st century for product quality in pharmaceutical industry. The conventional method of manufacturing pharmaceutical products is related with batch system that are used with laboratory testing procedures that are usually conducted on different samples that are collected for quality evaluation procedures. Conventional methods found to be successful in delivering quality products to consumers in pharmaceutical industry (Adebanjo and Kehoe,2001)
CFR 210/211 AND EU volume 4
Good manufacturing practices is used for safe manufacturing of pharma products and they are under control of Food and drug administration and Code of federal regulation in particular CFR 210/211 and also include European Union that is again under the control of European Medicines agency(EMA).There are different number of good manufacturing practices that are currently operating in different nations and it serves as additional dimension for process of regulation. Regulatory agencies that mainly control medicines production through different licenses include marketing authorization, manufacturers include special license, dealers and medicinal products. Compliance associated with these licences are generally assessed mainly based on inspections that are conducted through good manufacturing practices and it is performed every 2 years once.
The aim of regulators is to carry out assessment indicating that pharmaceutical industries are involved in product manufacturing after getting licence, procedures involved with documentation process and related policies. Current good manufacturing practices based on European union volume 4 it is mainly focused on recent topics for example novel introduction of medicines into market after performing clinical trials. Critical aspects of good manufacturing practices mainly include quality, purity, strength, identity and safety. Deming summarized the quality control aspects into 14 points that are interrelated to each other which focused on improvement of management and their performance considering quality. Juran reported that quality management can be referred to as fitness for use which is characterized by several features include availability, complete service, conformance quality and design quality (McAdam and Reid, 2000). Crosby explained about the term quality which is defined as conformance to requirement which means it is necessary to translate the necessary requirements for generating products and services with specifications that would enable product quantification based on product features (Crosby,1979). CFR 210 mainly focuses on requirements associated with good manufacturing practices that covers manufacturing process that includes controls, facilities for the process of manufacturing, holding and packaging drugs that follow recommended guidelines for purity, safety and quality. CFR 211 is focused on completed drug products that considers minimum good manufacturing products. It also includes different areas such as facilities, equipment, personnel, process of production, testing and its stability followed by labelling procedures (Deming,1986).
Ishikawa principles are considered to be as effective for management of quality through statistical based approaches .It is aimed at quality improvement of manufacturing companies for example pharmaceutical companies can sustain by upliftment of the industry and employees (Lee and Dale, 1998). Taguchi considered novel approaches for evaluation of product quality and there exists correlation in between size of market and loss associated with the product. The specification of the product is adhered to product quality and loss is reported mainly due to costs related with manufacturing process (Fong, Cheng and Ho, 1998).
Correlation of quality between loss and costs associated was expressed by Taguchi from a point of manufacturing. Taguchi explained about designing features associated with parameters, tolerance and system are mainly related with improvement in efficiency of the product in pharmaceutical industries (Guimaraes and Armstrong, 1998). Based on principles set according to EU Volume 4 it is mainly associated with total quality management will differ in general from one author to author but overall it helps in enhancement of pharmaceutical industries by competitive improvement, decreasing costs and also raise in profits are mainly considered for effective management of companies. Receiving total quality management guarantees that the administration association has a key diagram of value and spotlights on counteractive action not identification of issues (Kouzmin, Klages and Kakabadse,1999). The fundamental objective of total quality management is to meet client necessities and offer fulfilment. The fundamental thought of total quality management is that quality is basic in all elements of the business not simply producing; it is a framework approach that thinks about each cooperation between the different components of the association (Wiley,1999). With the developing interest for quality items, numerous activities were confined by associations to guarantee consistency in what they produce. Many nations are developing their quality administration methodologies and frameworks to meet the prerequisites of working condition(Gummesson,1998).
According to EU volume 4, Quality is essentially a method for dealing with a business association and furthermore give the word complete quality control. The clean pharmaceutical area has a well-characterized set of desires and guidelines that give clear explanations identifying with microbiological controls and observing (Lee and Cunningham, 2001). Interestingly, the desires for nonsterile pharmaceuticals are inadequately characterized, with scarcely any points of interest written in either enactment or direction distributions (Hackett and Spurgeon,1998). The administrative offices, in this way, anticipate that the business should adopt a hazard based strategy to microbiological control and apply properly advocated observing in the production of nonsterile pharmaceuticals (Larsen and Haversjo, 1999). This part traces the key necessities for GMP that can be applied over the pharmaceutical business. With microbiological parts of GMP, top level microbial oversight “administration” ought to be driven by senior level site the executives and not constrained to the senior microbiologist or quality affirmation (QA) administrator (Hales and Klidas, 1998). Clear heading should be given to the site accentuating that microbiological tainting control is a key factor in GMP. Multifunctional association of agents from assembling (specialized and tasks), building, QA the executives, and quality control (QC) microbiology ought to have an aggregate duty to guarantee the fitting quality frameworks are in spot to guarantee pharmaceutical control and management (Hunt and At-Twaijri, 1996).
Recent advances in technology has enabled to improve the manufacturing process of pharmaceutical products and also provide assurance in terms of quality through product innovation and analysis of process and its development and control procedures. Pharmaceutical industries tend to play a pivotal role in providing better health care services to the public (Al-Nofal and Zairi,2002b). For this reason there is need to introduce novel technology for manufacturing pharmaceutical products and this can be achieved by innovation and through proper utilization of engineering and scientific knowledge including core principles of management quality by responding to the new challenges includes discovery of new drug compounds and different ways to do business such as therapy or treatment procedures (Andersen and Moen, 1999).
It is critical that policies associated with regulation should raise as per the demands present in the industry and previously authorities such as United States Food and Drug Administration is conservative with reference to implementation of novel technologies that is used for patient safety. More focus is on drug production as per specification standards set by the administration using novel devices that are approved and safe for patients. Different countries including developing nations like India produce different types of drugs as specified recommendations as per guidelines set by the industries (Appelbaum et al,2000). It is critical to validate the manufacturing process extensively for ensuring safety of the patient. The process of approval requires more time and also considered as expensive which is referred to as deviation in pharmaceutical industry. Since there are lot of complications associated with drug manufacturing process it is important to ensure that assurance of quality should be performed once the product is produced and thus allow to enable sample testing procedures to be completed (Aune, 1998).
If there are any irregularities is identified with reference to parameters adjustment it should be clearly stated about the time that is consumed for material specification and should consider for rework again. This is in contrast to the principles recommended by Taguchi (Clarke,1998). Loss is generally due to quality issues that are mainly associated with manufacturing costs that include re-tooling and materials for production department until the product is sold or shipped out to the consumer. This is also completely against to Juran’s principles as it recommends to consider less expensive during first time rather than paying again for rework that includes repair (Juran,1993). The outcome of final result indicates that pharmaceutical companies are less superior in comparison with other industries specifically with implementation of advanced technologies associated with manufacturing process that would enable to improve the consistency of product and decrease the delaying process associated with release of product into market and also include decrease overall costs associated with manufacturing (Cornford, 2001).
Recent changes by Food and Drug Administration considering thought process has been made to push the quality of standards of pharmaceutical companies across the globe and also successfully implement the testing procedures and manufacturing methods. Food and Drug Administration published guidelines for improving quality of companies that are mentioned in the book titled as Process Analytical Technology. It helps to analyse, design and control process of manufacturing in pharmaceutical industries. The entire procedure involves controlled procedure which results in gaining higher yield and testing process is reduced. Monitoring quality through online will minimize the production and in turn decrease the costs related to manufacturing products (Davies and Kochhar,1999). The main objective of Process Analytical Technology is to better understand the process of manufacturing and its control. Variability that affects the process should be identified, described and managed are some of the important goals of Process Analytical Technology. It is very useful to enhance innovative procedures and also improve development of pharmaceutical products that assures the product quality.
Deming reported that it is critical to check the quality of the process at each single step instead of just focusing on end product or service provided after the completion of task. According to Deming most of the issues associated with product or services is mainly due to poor management and not because of irresponsible nature of workers at work place. Juran is familiar with concept introduction on business quality process and management considered as critical technique for execution of different functions for quality improvement. Cosby indicated the requirements that are stated are required to be translated into products or services with defined characteristics that are easily measurable. To enhance this numerical specifications are considered to quantify the product characteristics (Gore, Bond and Steven,2000). Taguchi framework designed for quality management give access to two ideas which include –Decrease in product variation and indication to reduced loss to the society. The variation reduction is mainly due to intentional development of proper strategy.
Feigenbaum is the one to introduce the concept of total quality control and described its importance during manufacturing process of product with good quality is highly recommended and not limited to only quality of the product and its implementation alone. Isikawa developed the quality circles concept with reference to total quality control for identifying the root cause for the problem and look for permanent solution for the problem mainly associated with quality management. For enhancement of products with better quality with safety measures, pharmaceutical industries build novel approaches that follow principles include good manufacturing practices, good clinical practices and standard operating procedures (Lee and Quazi,2001). Quality is considered as critical for pharma companies mainly because International competition, stringent requirements, advances in technology and new arrival of generic product. Based on principles of total quality management following conclusions can be made in relevance to pharmaceutical industry principles that are considered as critical include-Usage of products and drugs for customers, consumer based drug and timing is considered precious for both consumer and industry. Feigenboum approach is to set standard qualities that will enable to act on implementation of standards by focusing towards management considering social and technological aspects that will benefit the pharmaceutical industries but however there are drawbacks such as breadth of theory associated with management will not get recognized.
According to Feignenboum quality management is a continuous process which requires constant changes from time to time that can be fulfilled through connection between consumers and production department.
From the above it can be observed the different views of authors which is based on requirements of customer are critical for improvement of standards of the pharmaceutical company by meet the demands and goals of the customers (Johnson,1993). There are variety of definitions for the term quality and it varies from author to other but common point is constant improvement of products and services for effective management in pharmaceutical industries.
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