Introduction
This paper will focus on the technological developments that are driving the pharmaceutical industry. Governmental oversight imposed by the Food and Drug Administration requires strict accountability and quality control. We will look to the fast food industry for best practices considering the FDA also regulates this industry as well. A repeatable and auditable system of production, operation, and distribution will be the cornerstones of the technology employed.
Pharmaceutical Industry
The pharmaceutical industry is a highly regulated industry that is subject to continuous audits and monitoring form the government. The regulatory oversight to assure that the drug products meet the identity, strength, quality, and purity regulations begins with manufacturing of the investigational drug for its first use in human subjects and continues through the shelf life of the product (Velagaleti, Burns & Gill, 2003). Automation is one of the tools being used by the industry to minimize costs while complying with these regulations. In the beginning the Food and Drug Administration, FDA, government agency that regulates the industry, was very concerned on the effect that automation and cost reduction could have on the final product. This led to the review of the Code of Federal Regulations to regulate how to automate processes. The industry has invested a great deal of effort in demonstrating that automation, if handled correctly, does not jeopardize the final product or the consumers’ safety.
Complying with the regulations and fully automating requires an interaction between the SCADA, PLC, network, databases, servers and reporting tools. Supervisory Control and Data Acquisition (SCADA), as the name indicates, is not a full c...
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Office of Pharmaceutical Science (2005). Process Analytical Technology (PAT) Initiative. Retrieved on October 08, 2005 from http://www.fda.gov/cder/OPS/PAT.htm
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Perusing warning letters in FDA’s Electronic Reading Room yields a plethora of violations regarding adulterated, misbranded or falsely claimed benefits of drugs and supplements. These three issues, consequently, constitute stumbling blocks in drug development or approval and additionally, perhaps also indicate a wanton disregard of compliance in manufacturing and marketing. Do the responsible companies prioritize compliant procedures and documentation? Through investigating three of the most commonly cited reasons for FDA 483 letters, applying them to the above violations, and exploring a culture of compliance, some rationale for causes in this case may be determined.
The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
Why do consumers purchase specific drugs for various ailments, sicknesses or diseases they might have? Why do physicians prescribe certain drugs over competitive drugs that may be available to the public? Why is it that most of us can easily name specific drugs that fit the many ailments of today’s society? On the surface the answer might be as simple as good TV advertising or radio commercials or even internet adds. The truth of matter is the major pharmaceutical manufacturers own the patents on these drugs and this gives them all of the marketing budget and muscle they need to promote the drug and control the pricing. The incentives for larger pharmaceutical companies are very enticing and as a result, they don’t mind spending the time in clinical trials and patent courts to get their drugs approved. Some will even get patents on the process by which the drug is manufactured, ensuring that no competitor can steal the drug or the process. This protects their large financial investment and nearly guarantees a large return for their investors. Many consumer rights groups claim this is nothing more than legalizing monopolies for the biggest manufacturers.
Implementing technology in a clinical setting is not easy and cannot be successful without a well-organized system. It is important that healthcare providers understand the electronic medication administration record (eMAR) and its role in improving patient safety. One of the most significant aspects of healthcare is the safety of our patients. Medication errors account for 44,000-98,000 deaths per year, more deaths than those caused by highway accidents or breast cancer. Several health information technologies help to reduce the number of medication errors that occur. Once of these technologies is bar-code-assisted medication administration (BCMA). These systems are designed to ensure that the right drug is being administered via the right
PharmaCARE is one of the world 's most successful pharmaceutical companies that is enjoying a status as a nurturing, ethical and well-run business that manufactured high-quality healthcare products. Thus, saved millions of inhabits and enhanced the value of life for millions of people. The company provides free and discounted pharmaceuticals to low-income customers on the base of sponsors health care informative programs and scholarships. Two years before, after PharmaCARE 's research identified that one of its peak trading diabetes drugs (AD23) might slow the progression of Alzheimer 's infection. After identifying the weakness, its pharmacists began reformulating that pharmaceutical to maximize the effect. To avoid FDA inspection, PharmaCARE used US law to protect its intellectual property as it established a wholly-owned subsidiary, CompCARE that is set up beside its parent’s headquarters in a suburban agency park.
Responsibility and accountability become important when medical staff gives or doses patients with medication. The chance for making a medication error presents itself at all times. Those passing medications must follow established policies and procedures developed and laid forth by t...
medications is more than the act of getting drugs to a patient. The delivery of medication is directly tied to the charge for the medication. Thus the responsibility for charging or crediting medication belongs to technicians. This aspect of their job is strictly governed by federal regulations. These laws hold the technician directly responsible for the accuracy of a patient’s account’s charge and credit transactions. Because every dose is related to a specific day and time, when technicians credit they must apply that change to the corresponding dose. Assignificant as accuracy is to the patient’s account, accuracy in the making of their medications is even more important.
biopharmaceutical industry. Manuscript submitted for publication, Sloan School of Management and the Department of Mechanical Engineering, Massachusetts Institute of Technology, Cambridge, Massachusetts. Retrieved from dspace.mit.edu/bitstream/handle/1721.1/34827/61670866.pdf?sequence=1.
Administration of medication is a vital part of the clinical nursing practice however in turn has great potential in producing medication errors (Athanasakis 2012). It has been reported that over 7,000 deaths have occur per year related to medications errors within the US (Flynn, Liang, Dickson, Xie, & Suh, 2012). A patient in the hospital may be exposed to at least one error a day that could have been prevented (Flynn, Liang, Dickson, Xie, & Suh, 2012). Working in a professional nursing practice setting, the primary goal is the nurse and staff places the patient first and provides the upmost quality care with significance on safety. There are several different types of technology that can be used to improve the medication process and will aid staff in reaching a higher level of care involving patient safety. One tool that can and should be utilized in preventing medication errors is barcode technology. The purpose of this paper is to demonstrate how implementing technology can aid patient safety during the medication administration process.
Pauly, S. (2011, February). News from ABC: changes and challenges. Analytical & Bioanalytical Chemistry. pp. 1003-1004. doi:10.1007/s00216-010-4459-0.
Drug is a chemical which alters the processes in the organism, which is used in the medicine for prevention, diagnosis and treatment of the diseases (Farlex, 2011). Drug discovery is a long term process that needs money investment. The process of drug investigation takes approximately from 9 to 15 years during which the number of chemicals that can become drug is reduced from 10,000 to 1-2 (Saparov, 2011). Even after manufacturing the drug is studied by scientists for modifying its structure, delivery and effects on the organism. Drug discovery consists of several stages which help to examine its effectiveness and side effects.
Today the technological world has developed and has continued to innovate to provide an easier lifestyle. This is the main focus of automation. Automation has gained more recognition from people in the business and industrial sectors. The purpose of this report is to discuss and inform the overview knowledge in the automation field. “Automation is the system of manufacture designed to extend the capacity of machines to perform certain tasks formerly done by humans, and to control sequences of operations without human intervention” (Funk & Wagnalls New World Encyclopedia, 2017, p. 1). Humans are capable of such incredible things and have improved throughout time even develop automated technology to do those tasks. Automation and the technology
Will, L. ed., 2010. Technology and the Future of Pharmacy: A Roundtable Discussion. Computer Talk for the Pharmacist, [online] 30(3), 20-36. Available at: [Accessed on 11 November 2011]
Goal: To work as an accurate and effective technician with a good understanding of study drug regulations and the IDS distribution system.