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CHAPTER ONE

1.0       INTRODUCTION

Computer is rapidly finding its way into almost every human Endeavour owing to its veracity as data processing machine when the human mind is unable to effectively put on with the complex nature of today’s decision making.

Business today is conducted in an age of economic crisis and highly complex technology, imposing on business management the need to implement sophisticated business system, which accord, with present day needs. It is therefore necessary that effective and useful information should be available to an organization for efficiency.

Thus going by the forgoing, one may say that recurrence activity be it in business or otherwise need to be computerized and now online why having been opportune to work during holiday periods as a member of National Agency Food and Drug Administration Control, it occurred to my mind that computerization of the business activities is necessary.

There is rampant growth in the food and drug industry today, to meet with the challenges of fake drugs , expired drugs and non-hygienic food, every good manager must adapt to changes by embracing the newest technology, which is computerization and now online.

Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes pre-clinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may include the step of obtaining regulatory approval with a new drug application to market the drug.

Pre-clinical

New chemical entities (NCEs, also known as new molecular entities or NMEs) are compounds that emerge from the process of drug discovery. These have promising activity against a particular biological target that is important in disease. However, little is known about the safety, toxicitypharmacokinetics, and metabolism of this NCE in humans. It is the function of drug development to assess all of these parameters prior to human clinical trials. In addition, drug development must establish the physicochemical properties of the NCE: its chemical makeup, stability, and solubility. Manufacturers must optimize the process they use to make the chemical so they can scale up from a medicinal chemist producing milligrams, to manufacturing on the kilogram and ton scale. They further examine the product for suitability to package as capsulestablets, aerosol, intramuscular inject able, subcutaneous inject able, or intravenous formulations. Together, these processes are known in preclinical development as chemistry, manufacturing, and control (CMC).

Many aspects of drug development focus on satisfying the regulatory requirements of drug licensing authorities. These generally constitute a number of tests designed to determine the major toxicities of a novel compound prior to first use in humans. It is a legal requirement that an assessment of major organ toxicity be performed (effects on the heart and lungs, brain, kidney, liver and digestive system), as well as effects on other parts of the body that might be affected by the drug (e.g., the skin if the new drug is to be delivered through the skin). Increasingly, these tests are made using in vitro methods (e.g., with isolated cells), but many tests can only be made by using experimental animals to demonstrate the complex interplay of metabolism and drug exposure on toxicity.

The information is gathered from this pre-clinical testing, as well as information on CMC, and submitted to regulatory authorities (in the US, to the FDA), as an Investigational New Drug application or IND. If the IND is approved, development moves to the clinical phase.

1.1       BRIEF HISTORICAL BACKGROUND

The National Agency for Food and Drug Administration and Control (NAFDAC) is a Nigerian government agency under the Federal Ministry of Health that is responsible for regulating and controlling the manufacture, importation, exportation, advertisement, distribution, sale and use of food, drugs, cosmetics, medical devices, chemicals and packaged water.

FORMATION OF NAFDAC

The organization was formed to checkmate illicit and counterfeit products in Nigeria in 1993 under the country's health and safety law. Adulterated and counterfeit drugs are a problem in Nigeria. In one 1989 incident, over 150 children died as a result of paracetamol syrup containing diethylene glycol. The problem of fake drugs was so severe that neighboring countries such as Ghana and Sierra Leone officially banned the sale of drugs, foods and beverages products made in Nigeria.

Such problems led to the establishment of NAFDAC, with the goal of eliminating counterfeit pharmaceuticals, foods and beverages products that are not manufactured in Nigeria and ensuring that available medications are safe and effective.

The formation of NAFDAC was inspired by a 1988 World Health Assembly resolution requesting countries' help in combating the global health threat posed by counterfeit pharmaceuticals.

In December 1992, NAFDAC's first governing council was formed. The council was chaired by Tanimu Saulawa. In January 1993, supporting legislation was approved as legislative Decree No. 15 of 1993. On January 1, 1994 NAFDAC was officially established as a “parastatal of the Federal Ministry of Health”.

NAFDAC replaced an earlier Federal Ministry of Health body, the Directorate of Food and Drug Administration and Control, which had been deemed ineffective, partially because of lack of laws concerning fake drugs.

ADMINISTRATION OF NAFDAC

Chairman and council

“(NAFDAC) is headed by a chairman who presides over a governing council appointed by the president on the recommendation of the Minister of Health. “Other council members are:

  1. The permanent secretary of the Ministry of Health
  2. The director-general of NAFDAC
  3. Standard Organization of Nigeria (SON)
  4. The National Institute for Pharmaceutical Research and Development (NIPRD)
  5. The chairman of the Pharmacists’ Council of Nigeria (PCN)
  6. The chairman of the National Drug Law Enforcement Agency (NDLEA)
  7. A representative each of the Pharmaceutical Group and the Food and Beverages Group of the Manufacturers’ Association of Nigeria.

Three people from the general public are also represented on the council.

Several units make up NAFDAC:
  • The Legal unit is charged with offering legal advice on “law arising from Employee-Employer relationship and is the custodian of legal documents and all agreements relating to the Agency.
  • The Public Relations unit is headed by the director-general’s office. Its main function is to inform, enlighten and create awareness concerning the role of the Agency. The agency is divided into eight directorates with the last two newly added.
  • Internal Audit provides a means of measuring the effectiveness of the system of internal control and accounting, and carries out special investigations.

FUNCTIONS OF NAFDAC

NAFDAC has various basic functions. According to the requirements of its enabling decree, the Agency was authorized to:

  • Regulate and control the importation, exportation, manufacture, advertisement, distribution, sale and use of drugs, cosmetics, medical devices, bottled water and chemicals
  • Conduct appropriate tests and ensure compliance with standard specifications designated and approved by the council for the effective control of quality of food, drugs, cosmetics, medical devices, bottled water, and chemicals.
  • Undertake appropriate investigation into the production premises and raw materials for food, drugs, cosmetics, medical devices, bottled water and chemicals and establish a relevant quality assurance system, including certification of the production sites and of the regulated products
  • Undertake inspection of imported foods, drugs, cosmetics, medical devices, bottled water, and chemicals and establish a relevant quality assurance system, including certification of the production sites and of the regulated products.
  • Compile standard specifications, regulations, and guidelines for the production, importation, exportation, sale and distribution of food, drugs, cosmetics, medical devices, bottled water, and chemicals
  • Undertake the registration of food, drugs, medical devices, bottled water and chemicals
  • Control the exportation and issue quality certification of food, drugs, medical devices, bottled water and chemicals intended for export
  • Establish and maintain relevant laboratories or other institutions in strategic areas of Nigeria as may be necessary for the performance of its functions.

NAFDAC envisions that by making these functions known, that its actions will be apparent “in all sectors that deal with food, cosmetics, medical devices, bottled water, and chemicals to the extent of instilling extra need for caution and compulsion to respect and obey existing regulations both for healthy, living and knowledge of certain sanctions or default. Despite the establishment of NAFDAC, the sale and use of fake drugs did not end.

1.2       STATEMENT OF THE PROBLEM

In any activity there exists redundancy in making use of the brain. More so in any business concerned customer satisfaction or registration process may be delayed, hence increase cost of operation will result.

            The mode of registration has been a point of concern to the management. The issue of knowing at every point in time the company who has a particular request or making for misappropriation and ineffective management in order to overcome this hindrance in any organized institution/Firm undertaking so many courses  that the issue of registration and placement of list via the internet arose and authenticating their  product. There is also inefficiency, time wastage, no proper documentation and repetition of unnecessary records.

1.3       AIM AND OBJECTIVES

I hope the use of the result of this research is to create a registration portal that will amend the current process of registration and also identify problems associated National Agency for food and Drug Administration Control and new solution to these problems.

a.       To examine the manual mode of running a firm/companies registration.

b.      To antiquate the manual method of firm/companies records keeping.

c.       To develop a program using of computerization an online as solution to all other hindrance.

1.4       SIGNIFICANCE OF THE STUDY

The significance of this research therefore lies in the fact that much effort is required and must be maintained in order to keep the organization moving.

Thus, if the organization performed its role efficiency, there is the need to examine the impact of enhancing effective product registration portal by designing attractive site so as to maintain record and the profit goal for NAFDAC.

This study is therefore carried out to take care of large volume of files and folders are stored on the computer, these records will have capability of been accessed much faster and easier due to the high speed of online portal operations, which also reduces storage materials and chances of misplacing of files and losing information because    company data and information are fully captured when they apply for registration and better kept and secured. 

1.5       SCOPE AND LIMITATION

This research is narrowed to National Agency for food and Drug Administration Control Abuja and covers the online registration portal of its Firms/Companies engaged in the production of food and drugs and their bio data, due to lack of time and short break from for the research limiting factors of this research due to the workloads and lectures. Another limitation to this research is the lack of access to essential information.   

1.6       RESEARCH METHODOLOGY

1.6.1   METHODOLOGY

Due to the fact that the effectiveness and success of any data processing relies on data accurately sourced. Hence, both primary and secondary data collection techniques and methods were adopted.

Interviews were conducted orally on the department of NAFDAC information office, the staffs to some extent with facts duly extracted from both sides final documentation furthermore; the consultation of the NAFDC registration handbook from the organisation most especially cannot be overemphasized.

1.6.2   DEVELOPMENT TOOLS

The development tools consist of PHP, MYSQL, CSS, WAMP SERVER use for development of this research work.

PHP is a general-purpose scripting language that is especially suited to server-side web development, in which case PHP generally runs on a web server. Any PHP code in a requested file is executed by the PHP runtime, usually to create dynamic web page content or dynamic images used on websites or elsewhere. It can also be used for command-line scripting and client-side graphical user interface (GUI) applications. PHP can be deployed on most web servers, many operating systems and platforms, and can be used with many relational database management systems (RDBMS). Most web hosting providers support PHP for use by their clients. It is available free of charge, and the PHP Group provides the complete source code for users to build, customize and extend for their own use.

PHP acts primarily as a filter, taking input from a file or stream containing text and/or PHP instructions and outputting another stream of data. Most commonly the output will be HTML, although it could be JSONXML or binary data such as image or audio formats. Since PHP 4, the PHP parser compiles input to produce byte code for processing by the Zend Engine, giving improved performance over its interpreter predecessor.

Originally designed to create dynamic web pages, PHP now focuses mainly on scripting and it is similar to other server-side scripting languages that provide dynamic content from a web server to a client, such as Microsoft'sASP.NETSun MicrosystemsJavaServer Pages, and mod_perl. PHP has also attracted the development of many software frameworks that provide building blocks and a design structure to promote rapid application development (RAD). Some of these include PRADO, CakePHP, Symfony, CodeIgniter, Laravel,Yii , Phalcon and Zend Framework, offering features similar to other web frameworks.

Why I decided to go with PHP  instead of a Java framework.  And as I have actually re-considered alternatives, I also know firsthand how much PHP and the PHP ecosystem has matured and progressed the last few years, how PHP is positioned to provide the next.


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