Quality Of Good Manufacturing Practices

Due to these incidents and many severe cases of drug side effects that had happened in the past including deaths, the current way drugs are developed and approved are unethical. Therefore, reform in FDA’s management as well as the guidelines is necessary to strengthen safety standards and eliminate problems regarding drug development and regulation.

Forecasting activity being carried on by the principals of Fantastic for their business of ceiling fans marketing and assembling that was rapidly growing. Basic purpose behind making the forecasts was the decision on assembling and importing ceiling fans. The idea was to find a low priced, “assemble it yourself fan” from Taiwan and Hong Kong. These ceiling fans were cost effective as they reduced cooling cost during summer and heating cost during winter.

The WGU nursing program helped me in developing my professional definition of quality and safety by enlightening my understanding of root cause analysis, and system failures. The IHI course was an eye opener in my understanding of quality improvement, and the processes required to enhance safety and quality improvement. The courses that really assisted me in my definition include, the Organizational Systems and Quality Leadership, the Leadership and Professional Image, and Professional Roles and Values; and the Evidence-Based Practice and Applied Nursing Research.

The Federal Food, Drug Administration is responsible for establishing the Code of Federal Regulations which outlines the rules and regulations governing pharmaceuticals. The rules are divided into sections and include guidance based on drug categories. Due to each person having varying reactions to pharmaceutical products not all side-effects are detected during clinical testing. The Federal Food, Drug Administration is responsible for sharing the information with consumers. However, it seems a bit unethical because the large pharmaceutical companies do not have to share all of side-effect information that may assist consumers in making its choice on whether to try a product or to not try a product. Through various survey’s it was discovered that consumers are under the opinion that pharmaceutical companies need to have improved internal controls to ensure their compliance with regulations. Due to physicians and pharmaceutical companies working together and are dependent on one another there needs to be controls in place that would have an unbiased view of the regulations. The government will need to continue introducing new regulations that will aide in monitoring the relationships.

Company X shall retain a highly competent consulting firm that is qualified, and experienced in the application and implementation of cGMP activities that are important to maintain the quality and purity of products. The consulting firm after assessments of its operations, its procedures, processes, and its quality control systems shall make recommendations for improvement to address specific FDA concerns that will help us assure compliance with cGMP regulatory requirements for a long time to come. Keeping in mind the final objective to get into compliance, Company X shall take full advantage of that expert advice and will limit internal review only to remediate deficiencies outlined in the Warning Letter. Once corrections are implemented Company X shall ask FDA to re-inspect the facility and shall make plans for periodic announced and unannounced routine inspections by qualified professionals. Moreover, Company X shall plan to appoint an “advisory committee” comprising of specialists in GMP-facility management, engineering, and regulatory requirements to direct the whole

In today’s highly regulated environment for development and manufacturing of Pharmaceutical /biopharmaceutical Drugs and medical devices there is a heavy requirement imposed by the regulatory bodies, for the manufactures of drug products to provide an appropriate amount of assurance that critical processes employed in producing a drug substance or drug product can be shown to be both doing the right job, and doing the job right is often referred to as Validation.

One reason for why America heavily adopted standardized manufacturing was that America was experiencing a rapidly growing population. This was thanks to large amounts of immigrants entering the country and populating it. With a rapid rate of population growth there was rapid demand growth for specific types of commodities. The country at the time was growing nearly three percent per year in population which was double of any European country. The growth increased the market opportunity available. New households were being created and this required new improvement to transportation and railroad construction would be the large abundance of land available. With land not being a scarcity in America as it was in Europe meant the food prices in America were relatively low. This meant they had a large amount of disposable income because they weren’t spending a lot on food. They wanted specific commodities now. In order to meet the increasing demand and opportunity standardized manufacturing was a key adoption in doing so. For example, when the author states “Americans were rapid adopters of foreign technologies when it suited their economic needs, and they were also skillful in modifying someone else’s technology to make it more suitable to their needs” (Rosenberg, 105) which clearly shows technology was advancing with the Americans resources and skillset.

Brief surveys are conducted on a regular basis by the customer service department to ensure quality is consistent throughout the organization. The Federal Drug Administration (FDA) conducts audits of all manufacturing sites to ensure the proper goods manufacturing practices are followed. The FDA also reviews all standard operating procedures (SOPs) relating to product manufacturing and handling.

Q1. Based on the 2004 statement of profit and loss data (Exhibits 1 and 2), do you agree with Water’s decision to keep product 103?

Woolworths demands that HACCP plans are based on ‘Product Specifications’. The fact that it regularly assesses products’ compliance to specification is another factor towards maintaining a high standard of quality management.

In pharma industry the raw materials mainly consist of organic chemicals. The need of different organic chemicals depends on the chemical formulae of drug. Pharmaceutical industry depends on various different organic chemicals for the production of end drugs. The chemical industry itself is very competitive and also very fragmented because their products (organic chemicals) are standardized and steps to produce them are also standardized. The chemicals used in pharma industry are commodity as pharmaceutical companies do production on economies of scale to lower the cost. The suppliers have low bargaining power because companies can switch to a new supplier without incurring a high cost. But there is a threat from supplier if it decides to go for forward integration and become a pharma industry

Do you agree with Water’s decision to keep product 103? Continue Production End Production Sales (Net) $ 26,670,000 $ - (Less) Rent $ 1,882,000 $ 1,882,000 Property Taxes $ 401,000 $ 401,000 Property Insurance $ 534,000 $ 534,000 Compensation Ins. $ 458,000 $ - Direct Labor $ 6,879,000 $ - Indirect Labor $ 2,309,000 $ - Power $ 302,000 $ - Light and Heat $ 106,000 $ - Building Service $ 75,000 $ 75,000 Materials $ 4,851,000 Supplies $ 350,000 $ - Repairs $

Quality is defined as conformance to the requirement, not goodness: The first absolute explains that management must strive to ensure that during the quality improvement process everyone is getting things done right the first time. Crosby stated that in other to do this management must state clearly what are the individual roles of the employee, management must also supply the employees with the resources needed to do their task and lastly management must give continuous support and encouragement to the employees during the improvement process. When quality is defined as conformance to requirement it helps to reduce hassle and improve quality at the same time. Crosby (1995).

Quality assurance collectively influence the quality of a product. The product need to be designed and developed, considering GMP and GLP (Good laboratory practice). The system ensured that there is a procedure regularly for self-inspection and auditing.

This work is done to study the improvement of the quality in automobile industry. This chapter consists three sections named as “Problem definition”, “Objectives” and “Methodology of the study” respectively. The section 3.1 named as “Problem definition” describes the challenge or difficulty that is to be solved. The solution may be achieved after fulfilling the objective by using some sub-objectives that are described in section 3.2 named as “Objectives”. The methodology described in section 3.3 in details. This methodology has been devised keeping in mind the view of “Problem definition” and the “Objectives” that are suggested for the fulfilment of the solution for the problem.