1. INTRODUCTION AND MOTIVATION
Without an efficient management system which includes a standardised Pharmaceutical Product Registration (PPR) process, it is impossible to maintain a well-organized pharmaceutical business (Van der Merwe and Bredenkamp, 2013:101). A PPR is a process whereby a pharmaceutical organization (applicant) presents a Dossier to the South African Medicines Control Council (MCC) (Department of Health, 2017:10). The MCC inspects the dossier to assure that the specific pharmaceutical product is of adequate quality. The product will be safe to use and will be effective. This is done before market approval is granted to the organization (Brook, 2006:870).
The proposed research will focus on the optimisation of the Generic Pharmaceutical Product Registration (GPPR) process. This will be achieved through quantitative analysis of historical data obtained from existing records. This will take place in one of the leading generic pharmaceutical organizations in South Africa. This generic pharmaceutical organization will be referred to as Company X. This will apply throughout the entire proposed research. This is done to protect the identity of the organization.
An optimized process can help provide an organization with access to key performance indicators, good information for decision making, help to manage risk and enable the organization to operate proactively (Grigori, Casati, Castellanos, Dayal, Sayal and Shan, 2004:322). This will be achieved through Statistical Process Control (SPC) analysis of the existing GPPR process at Company X. Optimization will also be achieved through integration of Strategic Quality Planning (SQP) tools within the existing GPPR process at Company X. The SPC analysis and integration of SQP tools will culminate into a development of a Quality and Risk Management (QRM) model. This QRM model will be used to manage the GPPR process better at Company X, therefore optimise the GPPR process.
1.2 The Research Aim
The proposed QRM model will be set down within the existing GPPR process at Company X. The model will consist of a selection of QRM practises designed to manage the GPPR process. This model will also monitor and assess the impact of any variation experienced during the GPPR process. Noffke (2007:835) defines a variation as a delay in the GPPR process resulting from an unintended change or mistake that is noticed in the existing GPPR process. Normally, this change will end up affecting the safety, quality and efficacy values of a pharmaceutical product. In such circumstances, the Medicines Control Council (2005:16) requires an applicant to amend the dossier in order to maintain the safety, quality and efficacy values of a pharmaceutical product. This practise is commonly referred to as a Dossier Amendment (DA). Bates (2017:81) defines a DA as an update done in the dossier to reflect the changes on the quality, safety and efficacy values of a pharmaceutical product. This amendment will be submitted to the MCC for approval upon completion.
The model of QRM practices is believed to be capable of optimizing the GPPR process by:
? Tracking products in the registration pipeline.
? Helping the organization to measure performance during the registration process.
? Providing information on how long it may take before approval to market is granted.
? Provide the organization with information to select the most suitable date to launch the product.
? Enabling the organization to estimate their registration timeline performance against that of competitors willing to register same generic product.
? Provide the organization with information to anticipate the market position a product will reach after product launch.
The QRM model will be developed through utilizing data attained from analysing two parts of the generic pharmaceutical product’s life-cycle. The results attained from analysing the GPPR process (pre-registration) and the DAs submitted to the MCC after a product has been launched (post-registration). Thereby, the model will serve as a risk management tool. This tool will assist Company X to institute plans and actions to minimize variation risks associated with the GPPR process.
The current GPPR process at Company X does not have a formalised system to manage all the products in the registration pipeline better. The organization does not have an effective mechanism that can precisely anticipate registration outcomes. Lam and Lau (2009:6986) explain that it is essential for organizations to monitor their business processes continuously to sustain competitiveness in their business environment. Kang, Jung, Wook Cho and Kang (2011:661) state that organizations can monitor their business processes by having valid process observing models, coordinated with standardised quality control measures. Grigori, Casati, Castellanos, Dayal, Sayal and Shan (2004:321) believe that this can provide an organization access to critical process performance indicators, bolster decision making, managing risk amid execution of the process and enable an organization to operate proactively.
At present, there is only one mechanism which is used to manage a specific part of a product’s life-cycle at Company X. This mechanism is referred to as a “Change Control Amendment Tracker (CCAT)”. This CCAT is used to monitor the unintended changes noticed in the quality of the pharmaceutical product after a product has been launched (post-registration). The CCAT monitors all the DAs conducted on the approved dossier resulting from changes detected at post-registration. The CCAT is also used to track dates of submission and MCC approval for each DA.
However, Company X does not have a comparable monitoring mechanism in place for products in the pre-registration pipeline. Despite the fact that DAs conducted at pre-registration are not different from the DAs conducted at post-registration. The Department of Health (2017:15) has made it clear that all DAs go through the same MCC review process. DAs take the same amount of time before approval is granted, depending on the type of a DA. On the other hand, Trenholm (2016:49) asserts that when dealing with a long and comprehensive process such as GPPR, it is a good idea to have standardised quality control measures within the process. He believes this can enables an organization to significantly reduce efforts, risks and costs associated with the GPPR process. Van der Merwe and Bredenkamp (2013:111) emphasised that standardised quality control measures can improve management of a process by streamlining workflow and improve process timing by providing users with efficient tools to replace manual tracking processes.
2. BACKGROUND TO THE PROPOSED RESEARCH PROBLEM
The GPPR process typically takes approximately five years (60 Months) to complete. However, in certain instances such as, applying to register a medicine considered essential in South Africa, ‘fast track registration’ will take place. The fast track registration normally takes approximately two years (24 Months) (Department of Health, 2017:Online). A year before approval is granted by the MCC for a single product, the applicant is offered an opportunity to submit all the DAs resulting from changes experienced during the registration process. This opportunity is commonly referred to as a Pharmaceutical and Analytical (P&A) recommendation (Department of Health, 2017:19). The P&A recommendation requires an applicant to submit all the DAs within a three months period.
During the P&A window period, Company X submits the DAs for all the changes (on the product’s quality, safety and efficacy) which were noticed during the GPPR process. Preliminary investigation to the proposed research indicates that within the P;A period offered by the MCC, a trend of variations in the GPPR process is most likely to occurs. This trend results from unintended changes which surface right after all the parties involved (ingredients suppliers, Research and Development (R;D), manufacturing sites, and laboratories) are notified about the P;A recommendation. The most common causes of those variations include:
? The proposed Active Pharmaceutical Ingredient (API) manufacture can no longer supply the proposed API due to scarcity of raw material.
? Change in the technical grade of the API.
? Major in-process control parameter changes on the manufacturing process.
? Changes in the API’s Route of Synthesis (ROS).
? Failure of product quality during stability studies.
At this stage, Company X is forced to request for extension of the MCC’s P;A deadline. The extension period will last up until all the required data to amend the dossier is fully compiled and available. The compiled data will be submitted to the MCC for review and approval. The most challenging factor is that, the extension period may add up to 2 years until all the required data is fully compiled. This period will then end up affecting the existing GPPR process and time to market the product. This leaves the door open for competitors to take the first to market position and an opportunity to seize a big amount of the market share.
Even though Company X is not responsible for the changes experienced during the registration process, the organization is still responsible for monitoring those changes. The organization can be able to monitor and counteract on such risks. Unfortunately, there is no mechanism in place to monitor and mitigate such risks.
3. STATEMENT TO THE RESEARCH PROBLEM
Since 1991, Company X has registered more than 270 generic pharmaceutical products in South Africa. The organization operates through utilizing a process without using a reliable quality and risk management tools to monitor and manage the entire GPPR process better. This operating principle is unable to measure the impact of changes to anticipate unforeseen circumstances in the GPPR process.
4. THE PRIMARY RESEARCH QUESTION
How can the Quality and Risk Management (QRM) model be set down within the existing GPPR process at Company X to optimise the process?
4.1 Investigative (Sub) question/secondary research questions
? What features does the proposed model of QRM needs to provide a clear picture of the entire GPPR process at Company X?
? What are the significant tools that can assist the model of QRM to measure progress and provide possible product approval dates?
? How can the proposed model of QRM be able to manage risks associated with the GPPR process?
4.2 Primary Research Objectives
? To identify key features that the proposed model of QRM needs to provide a clear picture of the entire GPPR process at Company X.
? To identify key significant tools that can help the model of QRM to measure progress and provide possible product approval date?
? To determine and incorporate key aspects to the model of QRM which will manage risks associated with the GPPR process.
5. THE RESEARCH APPROACH
The researcher will use the quantitative research approach to analyse the GPPR timelines for all generic products registered between the period of 2008 to 2016 within Company X. The researcher will also quantitatively analyse the DAs conducted between the period of 2011 to 2018. The records in place at Company X consist of data for products registered and DAs conducted within the specified time periods above. The data will be analysed by using the following Statistical Process Control (SPC) and Strategic Quality Planning (SQP) tools:
? Process capability: to test how well the GPPR can produce acceptable results?
? Pareto analysis: to identify the major, moderate and minor DAs.
? Control charts: to determine the current and future process time specifications.
? Activity Network Diagram: to identify the critical paths of the GPPR process and possible delay times.
? CUSUM chart: to detect time specification shifts on the process.
? EWMA charts: to forecast the average process time specifications.
? Normal distribution: to make inferences about the existing GPPR data.
? Achieved and Inherent Reliability: to predict consistency of the GPPR process.
? Regression analysis: to determine functional dependency between different stages of the GPPR process.
The results obtained from data analysis will be used to design the proposed Risk and Quality Management (QRM) model. Each outcome will be incorporated to the QRM model to serve a specific function on the optimised GPPR process.
6. THE RESEARCH PROCESS
Patel (2015:112) define a research process as a “systematic way in which a researcher approaches the area of study to produce knowledge which the community will consider to be worthwhile within the field”. Blankenship (2010:125) explains that a research process involves multiple-steps, where the steps are interlinked within the process. If changes are made in one step of the process, the researcher must review all the other steps to ensure that the changes are reflected throughout the entire process.
The following research steps will apply during the proposed research:
? Identifying research problem.
? Search for information or literature regarding selected research topic.
? Assembling of key knowledge about research environment.
? Identification of major literature sources.
? Drafting of a research background and research framework.
? Identify and develop research topic.
? Formulation of research questions and objectives.
? Review the literature.
? Select research design and methodology.
? Stipulating data collection design and methodology.
? Data analysis and discussion.
? Produce conclusions and recommendations.
The research steps set above depend on what the researcher learns during the research. Some of the steps have and will be conducted more than once if change on the approach is required. Also, any changes to the above steps depend upon the research scope, amount of research data secured, and relevant literature resources found. Judging from the research environment and topic, it is most likely that the researcher might not follow all the steps stipulated above in a step by step approach. In other words, the researcher may not conduct the second step right after the first step, each step is dependent upon what is found during the research.
7. ABBREVIATED LITERATURE REVIEW: THE PHARMACEUTICAL INDUSTRY
7.1 The Pharmaceutical Industry and Reason for its Regulations
The pharmaceutical industry is the part of the healthcare sector that deals with producing medications. The industry includes distinctive sub-fields relating to the development, production and marketing of medication (Busfield, 2006:299). The main goal of the pharmaceutical industry is to provide pharmaceutical products that prevent infections, maintain health, and cure diseases (Benson, 2015:640). Rago and Santoso (2008:66) believe that pharmaceutical products are not ordinary consumer’ products. They explain that in most instances, consumers are not in a position to settle on choices about when to utilize pharmaceutical products. Or which products to utilize and how to utilize them.
Consumers are not able to measure potential advantages against dangers as no medication contains an efficacy value without side effects. This is the reason why medications are regulated (Rago and Santoso, 2008:67). The government has a responsibility to intervene to ascertain safety, efficacy and quality of the pharmaceutical product (World Health organization, 2006:11). This process is achieved through an extensive review and examination of data regarding the pharmaceutical product under registration. This data consists of animal studies, toxicity studies, stability studies, clinical trials and specifications of the manufacturing process (Black, 2001:105).
7.2 The South African Medicines Control Council
Since 1937 up until the mid-1960s, the thalidomide and other related tragedies resulted to more than 10 000 casualties around the world. This was due to consumption of unsafe medicine (Mulinari, 2016:75). This made many governments realise that all medicines should first be fully tested before they could be sold to the public. Those tragedies played a foundational role in design and development of pharmaceutical regulations (Stossel, 2011:439). All conditions in pharmaceutical regulations were responsively drafted to guarantee that occasions that prompted those tragedies would not repeat (Hara, 2003:35).
According to the South African Department of Health (2017:3), In the last fifty years, South Africa has developed a medicines regulatory authority with global recognized standing. The organization is part of the South African Department of Health (SADoH) known as the Medicines Control Council (MCC). The MCC applies standards laid down by Medicine and Related Substances Act (Act 101 of 1965). The Medicines and Related Substances Act 101 of 1965 (South Africa, 1965:2) governs the research, development, manufacturing, advertising, marketing, distribution and sale pharmaceutical products. The South African’s Medicines and Related Substances Control Act 101 of 1965 (Medicines Act) was first passed in 1965. Although it has been amended many times since then (MCC, 2005:18). Before 1965, medicines could be sold without the manufacturer having to prove that they were safe or that they actually worked as claimed in the Patient Information Leaflet (PIL) (Department of Health, 2017:29).
7.3. Generic vs Original or Brand-name Pharmaceutical Products
According to Stoppler (2014:770), the generic pharmaceutical products are copies of brand-name pharmaceutical products. They have exactly the same intended use, dosage, effects, risks, route of administration, strength and safety as the original pharmaceutical product. In other words, generic pharmaceutical products have exactly the same therapeutic effects as the original products. On the other hand, Donohue (2006:671) suggested that generic medicines are usually less expensive than the original medicines. They are less expensive because the producer did not spend money to research and development the medicine. Generic medicines are developed through replication of the original medicine.
7.4 The Generic Pharmaceutical Product Registration Process
The Generic Pharmaceutical Product Registration (GPPR) is a procedure whereby an organization also known as an ‘applicant’ presents a Common Technical Document (CTD) (also known as a ‘Dossier application’) to the South African Medicine Control Council (MCC) (Department of Health, 2017:41). The MCC inspects the dossier to assure that the specific pharmaceutical product is of adequate quality, will be safe to use and will be effective (Medicines Control Council, 2005:23). This is done before market approval is granted to the applicant (Brook, 2006:874). There are two types of the GPPR process, namely a normal GPPR and fast track GPPR processes (Department of Health, 2017:45).
The normal GPPR process typically takes approximately five years (60 months or 1 825 days) to complete. However, in certain instances such as applying to register medicine considered to be essential in South Africa, ‘fast track registration’ can take place. The fast track registration normally takes approximately two years (24 months or 730 days) (Department of Health, 2017:50). A product can only go through the fast track process only if it appears in the National Essential Drug List (NEDL). The NEDL are those pharmaceutical products that satisfy the priority healthcare needs of the South African population (World Health Organization, 2006:86). A broad explanation of the fast track GPPR process will be provided below.
7.4.1 The Normal and Fast Track Registration Process
A single dossier for each product consists of three modules presenting product quality, safety and efficacy values (Van derMerwe and Bredenkamp, 2013:112). Below is the list of all stages a complete dossier goes through for evaluation by the MCC during the registration stages:
Naming and scheduling: An organization is required to submit five brand names for each molecule. An organization gets notification as to which brand names is accepted by the MCC.
Pharmaceutical and analytical (P;A) and Clinical: The dossier application goes through the MCC’s clinical committee evaluation to ascertain quality, safety and efficacy. The clinical committee evaluates the proposed package inserts or patient information leaflets and label texts. The information is evaluated against clinical data provided by the organization to ensure observed benefits and side effects are reflected.
Inspectorate and law enforcement: The proposed Active Pharmaceutical Ingredient (API), Finished Product manufacturing sites and test laboratories are inspected by the MCC’s inspection committee for Good Manufacturing Practise (GMP) compliance and applicable quality standards.
Operations and administrations: Receipt of the manufacturing and registration certificates from the MCC.
Table 1: Normal and fast track generic pharmaceutical product registration process (Leng, Saunders and Pollock, 2015:58).
Within the ambit of the registration stages specified above, an organization continually receives notifications of the results on each stage as updates on the progress of product registration until approval is granted (Medicines Control Council, 2005:26).
7.4.2 The Fast Track Registration Process
According to the World Health Organization (2006:74), a fast track registration process can only occur if an organization is applying to register a generic pharmaceutical product that is:
? On the National Essential Drug List (NEDL); or
? Deemed to be “essential for national health” by the South African Minister of Heath.
? Allowed to be registered using the regulation of the Medicines Act 101 of 1965 that allows for a product to be registered using an abbreviated submission.
Fast-track registration can take place in two ways (World Health Organization, 2006:76):
? The application “jumps the queue”, provided the dossier is as complete as any other.
? It makes use of regulation of the Medicines Act 101 of 1965 that allows for a product to be registered using an abbreviated submission. The Medicines and Related Substances Act 11 of 1965 (South Africa, 1965:21) allows abbreviated submission only if the product has already been registered by other regulatory authority trusted by the MCC. Other regulatory authorities include the United States Foods and Drug Administration (USFDA) and European Directorate for the Quality of Medicines and Healthcare (EDQM). Approval certificate from those two regulatory authorities must be submitted with the abbreviated submission to the MCC.
7.5 The Relationship between Product Registration and Time
Ellis brings up with another motivating factor that foregrounds the importance of having an effective process in place to monitor and effectively manage the GPPR process. Ellis (2015:36) believes that the most important factor for any pharmaceutical organization is to be the first or second to launch a good quality generic pharmaceutical product. Previous studies by Ahlawat, Chierchia and Van Arkel (2013:3) have demonstrated that sustainability in the pharmaceutical industry is dependent on an organisation being the first or second organisation to launch a good quality generic pharmaceutical product. Ebeling (2011:825) explains the principal motivation behind organisations striving to be the first or second to launch a good quality generic pharmaceutical product to market is based on the preferences of retailing South African (SA) pharmacists. SA pharmacists prefer to sell which ever generic products that arrives first and second on the market, because it is complicated to explain bio-equivalence to patients for multiple generic products Hollis (Ebeling, 2011:825).
This explanation is again supported by Ellis (2015:39) who stated that SA Pharmacists reported feeling uncomfortable prescribing a different medication from the one frequently given to patients. Even if the product has the same pharmaceutical properties as the original. Ahlawat, Chierchia and Van Arkel (2013:5) explain that generic medication is cheaper than the original patented products. This allows patients is to accept the first or second generic in market, due to cost effectiveness. Patients are less willing to be switched again to another product which does not differ in cost from the first and second generic. On the other hand, Ebeling (2011:830) explains that it is unlikely for the first launcher generic to market to meet the entire demand. There is also a good change for a second launcher to retain a reasonable amount of the market share too.
7.6 The Generic Pharmaceutical Product Launch
A new pharmaceutical product launch is one of the most complicated marketing procedure in existence. Especially when the launch environment includes significant competition as well as legal, quality related and liability factors. This causes the level of complexity to keep growing dramatically (Ahlawat, Chierchia and Van Arkel, 2013:14). Since generic pharmaceutical organizations prefer pursuing for the first or second to market position, “The quality and time-to-market a new generic product is an important source of every generic pharmaceutical organization’s competitive advantage” (Benson, 2015:638).
It can be contended that in most generic pharmaceutical organizations, more research is required to find out how a product launch model can be created to keep up with the competition (Trenholm, 2016:126). Considering the above statement, Pan (1991:69) believes that close attention should be given on foreseeing new product launches by means of introducing significant quality and risk management models. Consequently, salesclerks working in generic pharmaceutical organizations need information, ideas, and models that will enable them to execute powerful and best product launch strategies.
7.7 The Pharmaceutical Competition Landscape
Most global generic pharmaceutical organizations are realising similar products at similar times in growing medicine categories (Ellis, 2015:50). Product performance results are transparent for every generic organization to see through the Intercontinental Marketing Service (IMS) provided by the Quintiles IMS institution (Lam and Lau, 2009:6990). Lam and Lau (2009:6991) explain that IMS provides performance results of every pharmaceutical product in various countries, including the South African market. Bates (2017:74) believes that everyone is using the same data to make the same decision.
This is making the competition more challenging for generic pharmaceutical organizations (Bates, 2017:75). Sapienza (1993:6) thinks that global pharmaceutical companies need to understand and take proper actions on the delays experienced in the GPPR process. Noffke (2007:835) explains that pharmaceutical organizations need to fully understand the strategic and tactical planning implications associated with quantifiable and hypothetical potential risks related to the GPPR process. Along these lines, organizations need to develop contingency plans to counteract the actions of competitors (Noffke, 2007:835).
7.8 The Consequences of Registration Variation
Time and product quality are the most valuable pieces to measure possible market share prior to any Pharmaceutical Product Registration (PPR) process (Ellis, 2015:52). In global pharmaceutical companies, launching a new product is more than just an increase in product portfolios. It also means gaining of millions of Rands (Noffke, 2017:837). On the other hand, Ebeling (2011:828) explains that GPPR process variations are inevitable part of the registration process. All variations result in affecting the registration time to obtaining approval from the regulatory authority. This automatically affects the quality of the registration process itself and reduce the changes of increase in market dominance.
Black (2011:118) illustrates that given the high stakes and aggressive landscape of the pharmaceutical industry today, a delay in launch can cost an organization an average of $15 million per pharmaceutical product. In South African currency, the costs can add up to R195 million per product. Noffke (2017:839) emphasised that delaying the launch of a pharmaceutical product puts an organization’s capacity to recover its investment in the product at risk. This squanders valuable time and can leave the door open for competitors to seize market share or even a first and second to market position.
7.9 Product Registration Process Efficiency
To avoid uncertainty to figure out how a GPPR process can be optimized to enhance process efficiency, Trenholm (2016:130) explains that it is important to first understand that operational efficiency is not tied in with cutting hard costs. Meaning, reducing employees and organizational annual spending. Operational efficiency is more about looking at how the structures of the organization or operations in general capacity and setting aside the opportunity to tie all the little pieces together.
Ljungberg (2002:254) believes that “in general, efficiency is one of the most important norms of process measurement”. He explains that accurate execution of any procedure is crucial to avoid poor performance. Most customers who are buying a pharmaceutical product expect fulfilling benefits. (Devlin, 2010:142) avers that the input from external consumers alone is not the only foundation used to build process efficiency. Internally, process efficiency can be measured through “application of cost of quality, non-valued added cost, non-value-added time, total processing time and resource utilization per unit of output”.
Trenholm (2016:145) states that assessment of GPPR process time and quality at all phases throughout the entire procedure can play a significant role. This can help call attention to numerous components that support or impair process efficiency. In this way, an assessment can also provide substantial information that can be utilized to enhance process control and change (Trenholm, 2016:145). When a process contains performance measurement and risk management tools, they can be more useful to draw out the components and stages that are key to be given close observation, control and change (Ljungberg, 2002:287).
7.10 Statistical Process Control and Strategic Quality Planning
Statistical Process Control (SPC) is a method used to measure, analyse and control quality of a process through statistical analysis (Hara, 2003:125). According to (Fotaki, 2011:55), SPC is an effective tool used to support Continuous Improvement (CI). He explains that CI is achieved through continuous monitoring and controlling of a process. CI also ensures that a process operates at its maximum capacity. Abraham and Davis (2011:792) believe that a process can operate at its maximum capacity, through utilization of the Strategic Quality Planning (SQP) technique.
Fotaki (2011:58) defines Strategic Quality Planning (SQP) as a technique which is used to monitor process activities. He explains that the technique displays the sequential correlation of activities in a process. The SQP technique is used mostly in process management. The tool is essential for the identification of a process’ critical path. The tool is used to determine the expected completion time for any process (Fotaki, 2011:58). Lastly (Hara, 2003:130) explains that when a process produces unstable results, SPC and SQP are used to reduce variation to achieve the best target values, therefore optimize the process.
8. THE RESEARCH DESIGN AND METHODOLOGY
Quantitative research method will be the most appropriate research methodology for the proposed study. Creswell (2003:45) defines quantitative research method as assembling, analysis and interpretation of numerical data to produce comprehensible results. Under the quantitative method, a case study will be selected as the most suitable quantitative paradigm for the proposed research. Benz and Newman (1998:45) define a case study as comprehensive analysis of circumstances. Yin (1994:45) explains that a case study method is mostly applied in a broad scale research environment to narrow down a research framework. He explains that the framework is narrowed down to a specific and important components to focus the research on.
Since the GPPR process is considered as one of the most comprehensive processes in the pharmaceutical industry by (Brook, 2016:873), the selected research method and paradigm will be used to narrow down the research framework. This method is believed to be capable of providing a suitable course towards optimization of the GPPR process at Company X. The will occur though application of the Statistical Process Control (SPC) and Strategic Quality Planning (SQP) Techniques. In addition, Collis and Hussey (2003:85) state that a case study does not necessarily provide a straight answer to the research question. A case study provides recommendation and allow supplementary interpretation and hypothesis construction on a subject.
8.1 Data Collection Design and Methodology
Based on the aim of the proposed research, the most appropriate data collection method is “systematic data collection from existing records”. Hatry (1994:381) state that existing records refer to information procured from secondary sources as opposed to from original data collection efforts. Jewkes (2016:2) states that systematic data collection from existing records is collecting data from an organization’s system. He explains that the data is in a form of existing and historical records. Existing data is acquired from databases, reports, records, process management systems, performance measurement systems and so on. Khan (2014:46) explains that when time and assets are a factor, existing records regularly give the most productive and powerful methodology.
8.1.1 The Target Population
Cronje (2016:133) defines the target population as “everyone or everything that falls within the population parameters”. To clearly define the target population, the important aspect the researcher kept in mind is that all the entities in the population should share at least one specific characteristic that relates to the research question. The target population is as follows:
? Registration timelines of 111 products which went through the normal GPPR process.
? Registration timelines of 32 products which went through the fast-track GPPR process.
? 416 Post-Registration Dossier Amendments (DAs) approved by the MCC.
? Intervals of each stage in the fast-track GPPR process for 27 registered products.
? Intervals of each stage in the normal GPPR process for 35 registered products.
? Average durations for each of the 8 activities conducted during the GPPR process.
8.1.2 The Sampling Method
The selected sampling method will be ‘Census Sampling’. Benz and Newman (1998:60) define census sampling as “a study of all the units in a population”. This means, the researcher will analyse all the data acquired from the existing records at company as specified in 8.1.1. Leedy and Ormrod (2001:92) explain that census sampling is one of the most preferred sampling methods by most researchers. The method is regularly utilized as a part of quantitative research since it expels human bias.
8.1.3 Unit of Measurement
Williman (2008:47) clarifies that ‘units of measurements’ are associated with numerical measurements. These include metres, kilograms, seconds and so on. Within the ambit of the proposed research, the units of measurement will be divided into two categories, namely;
? Discrete variables: Dolphin (2016:792) describes discrete variable as variables that can only take on a certain number of values. In other words, they don’t have an infinite number of values. If a set of items can be counted, then it’s a discrete variable.
? Continuous variables: Stephan (2013:118) defines continuous variables as variables that have evolving values. The values can fluctuate starting with one illustration then onto the next. A continuous variable is a variable that has an endless number of conceivable values. At the end of the day, any value is workable for these variables.
Discrete variables will apply during analysis of Dossier Amendments (DAs) experienced after registration (Post-Registration). The second unit is ‘years, months and days’ which is referred to as continuous variables. This unit will be used during the analysis of GPPR timelines, intervals of the GPPR process, duration of GPPR activities and Post-Registration DAs analysis as well.
9. DATA ANALYSIS
Creswell (2003:235) states that data analysis is a procedure of investigating, scrubbing, renovating, and exhibiting data. This is done with an ultimate objective of finding helpful information, recommending conclusions, and supporting decision-making. There are two types of statistical principles or techniques that will be utilized for examining and elucidation of data. The selected methods are known as descriptive statistics and Exploratory Data Analysis (EDA).
Janes (1999:402) describes descriptive statistics as a summary of insights that quantitatively portray or abbreviate highlights of a group of data. Descriptive statistics intends to outline the data to get more insight about the population that the data speaks to. On the other hand, Saunders, Lewis and Thornhill (2000:62) believe that in statistics, EDA deals with breaking down data sets to portray its fundamental attributes, regularly with visual techniques. Beyond the formal modelling or hypothesis testing task, EDA is for seeing what else the data can tell us.
The data will also be analysed by using the following Statistical Process Control (SPC) and Strategic Quality Planning (SQP) tools:
? Process capability: to test how well the current GPPR can produce acceptable results?
? Pareto analysis: to identify the major, moderate and minor DAs.
? Control charts: to determine the current and future process time specifications.
? Activity Network Diagram: to identify the critical of the GPPR process and possible delay times.
? CUSUM chart: to detect time specification shifts on the process.
? EWMA charts: to forecast the average process time specifications.
? Normal distribution: to make inferences about the existing GPPR data.
? Achieved and Inherent Reliability: to predict consistency of the GPPR process.
? Regression analysis: to determine functional dependency between different stages of the GPPR process
The analysis and interpretation of data forms the foundation of the research findings, conclusions and suggestions (Dolphin, 2016:793). This step will provide foundation for the designing and integration of the proposed model of Quality and Risk Management (QRM) within the GPPR process at Company X. The researcher will utilise the theoretical framework to interpret and support the findings. This will also help draw down the recommendations for further research.
10. DATA VALADITY AND RELIABILITY
Cronje (2016:254) explains that reliability is connected to the findings of a research. He clarifies that to evaluate if the research technique or instrument is reliable, the researcher needs to ask one question. “Can similar outcomes be created if the same research would be rehashed by an alternate scientist at an alternate time utilizing similar strategies or directions”? Du Plooy (2001:55) explain that reliability means, in the event that somebody questions the research, will it stand up to scrutiny? Reliability of the research will be addressed by:
? Collecting data as it is from Company X’s records database, using the proposed sampling method.
? Providing the exact list of tools employed during data analysis.
? Provide clear illustration of how each tools has been used to analyse the data.
? Avoiding data manipulation to fit the scope and objectives of the proposed study.
? Presenting raw data utilized in the research in the research annexures. Please note, information that can be traced back to the organization of interest will not be presented to protect the organization’s identity.
Barnes (2016:878) has pointed out that validity decides whether the research genuinely measures what was expected to be measured and how honest the study outcome is? Does the research instrument enable the researcher to hit “the dead centre” of the research topic? Collis and Hussey (2003:56) indicated that a good question to ask in order to decide the validity of a research is: Do the findings reflect what is going on in the given circumstance? Validity of the research will be addressed by:
? Analysing the data at least twice to ensure the same results can be obtained.
? Reporting research findings with honesty.
? Avoiding manipulation of findings to support the research objectives.
? Clearly highlighting any factors coming out of the research findings which were not part of the initial research aim.
? Clearly highlighting the theoretical framework utilized within the ambit of the research to interpret and support the research findings.
11. RESEARCH ETHICS
In this section, ethical considerations are tended to with regards to quantitative research. According to Saunders, Lewis and Thornhill (2000:82), ethics allude to the respectability of the researcher’s conduct in connection to the privileges of the organization becoming the subject of the research. This study respects the anonymity of the organization which will be involved in the proposed research. The researcher has the responsibility to conduct research in such a way that respects and maintains the organization’s rights (Sekaran, 2001:76). The researcher needs to ensure the protection of the organization from any possible costs, which may result from the study (Creswell, 1994:55). The researcher has also taken note of that the organization ought not be subjected to research of any nature unless they agreed upon. The following ethics have been practised in the proposed research:
? The researcher has signed a confidentiality letter on the security of information shared or found, that might cost the organization of interest.
? The researcher has obtained letter of consent from the organization on which the research will be conducted. The letter clearly explain the research topic, scope, what data will be utilized from the organization. Lastly, how the organizations identity will be protected.
? The researcher will adhere to the obligation of ethical practice during the research. Marnewick (2012:74) explains that the ethical practise mandates that researchers to inform the research subject about: the purpose of the research, expected duration and procedures. The research subject has a right to decline to participate and to withdraw from the research once it has started. The anticipated consequences of doing so must be clearly highlighted by the researcher.
? Research findings will be reported honestly.
12. RESEARCH ASSUMPTIONS
Marilyn (2011:16) believes that ‘assumptions’ in research are things that are thought to be true with lack of evidence to support the claim. However, if they disappear, the research would become insignificant. The following assumptions are anticipated to come out of the proposed research:
? The current Generic Pharmaceutical Product Registration (GPPR) process at Company X is not efficient.
? Most registered products were not registered within the anticipated registration duration for normal and fast track GPPR process.
? Major changes resulting from Third Party Contractors (TPCs) before (pre-registration) and after registration (post-registration) are the most dominant causes of the GPPR variations.
? All the products which experienced variations during the GPPR process lost their anticipated market position.
13. RESEARCH CONSTRAINTS
Research constraints are ordinarily alluded to as ‘limitations’ and ‘delimitations’ of a research (Williman, 2008:51). Research constraints relate to any pressing elements, which restrict the researcher’s capacity to conduct the research in a normal way (Ray, Sarkar and Sanyal, 2008:157). Marilyn (2011:17) explains that limitations are potential weaknesses in a research which are out of the researcher’s control. The following constraints will be expected to interfere within the ambit of the proposed research:
? The choice of research topic itself.
? Not enough data to analyse.
? Time constraints.
? Reliability of data.
? Legal and ethical constraints.
? Implicit or explicit understanding of what the study will not cover.
? Allowance by the selected pharmaceutical organization to provide raw data in the research report.
14. CHAPTER OUTLINE
Chapter 1: Introduction and Background
Introduction and background will depict the extent of the study and give a short clarification and synopsis of the research and a history in view of the proposed research topic. This chapter will likewise clarify certain components that are critical to the research. The readers will have a thought regarding the accompanying content before they begin understanding it.
Chapter 2: Holistic Overview of the research environment
Holistic overview of the research background and environment will give data in light of the idea of the pharmaceutical segment in South Africa. This chapter will also give history of the organization under study. The research will also highlight particular parts about the attributes of the organization which are vital for the proposed research. Same information in this part will not be presented to protect the identity of the organization.
Chapter 3: Literature Review
Literature review will provide important points such as current knowledge including substantive findings. The literature will provide theoretical and methodological contributions to the proposed research topic. Literature review will also help provide additional information to support the research finds.
Chapter 4: Research Design and Methodology
Research design and methodology will give the information on ‘how’ the selected method will be used to answer the research question. The plan and approach of the study will fill in as an outline itemizing what will be done and how it will be refined.
Chapter 5: Data Analysis and Interpretation
Analysis and interpretation of data will involve inspecting, cleaning, transforming, and modelling data. The goal for this chapter is to discover useful information, narrate findings. This chapter will also build foundation for the proposed model of Quality and Risk Management (QRM).
Chapter 6: Discussion
Discussion will express the researcher’s understanding and conclusions. This chapter will also clarify the ramifications of the research findings, and influence recommendations for future research. The discussions will answer the questions postured in the introduction, clarify how the findings fit in with existing information on the theme.
Chapter 7: Model Development
This chapter will utilise the results obtained from data analysis. The results will be used to create the QRM model. The researcher will provide a clear explanation of the purpose of each stage involved in the model. The model will also utilise all the theorical framework discussed in chapter 3 and 6 to ensure every stage involved in the model makes since and is not out of the research scope.
Chapter 8: Conclusions and Recommendations
In this piece of the study, the most essential purposes of the research will be given. Background to the research, research objectives and different viewpoints will be pointed out as recommendations of the study.