Legal and Ethical Issues in Business

Legal and Ethical Issues in Business

Introduction

The Code of Ethics and Business Conduct applies to all employees, including managers and must be consistently enforced.

The Company is committed to the ethical standards of business conduct and the highest. It conducts its operations as a socially responsible and observes all the laws and regulations that apply to the Company or the conduct of its business. This commitment and standard of conduct governing our relationships with customers, suppliers, shareholders, competitors and the communities in which we operate, as well as our relations with each other as employees at all organizational levels.

The Code is an expression of our fundamental values ??and represents a decision framework. To this end, it is for each employee to understand the Code and comply with them. The Code cannot and is not intended to cover all laws and all applicable regulations or to respond to all questions that may arise and to this end, we must ultimately rely on common sense of each employee for determine what is right, especially when it is appropriate to seek advice on what to do.

The company mentioned in this paper is a pharmaceutical company manufacturing an antibiotic drug by the name of Evon.

Discussion

The Code of Ethics requires that it is necessary to bring in to the knowledge of the CEO and colleagues about the manufacturing process of the drug by the name of the Evon being manufactured in batches. While following the best industry practices it is our understanding that a formulation of a drug is accepted once it has been rigorously tested for adverse affects and after passing through proper quality control procedures approved by the regulatory authorities. It is determined by the FDA (Food and Drug association) that the occurrence of any changes during to the manufacturing or storage of the drug and the deviation from its original consistency would require a recall from the market, if it has been distributed. The product is then labelled as being potentially harmful for human consumption, due to the change in the physical and chemical properties. (Data retrieved from: www.fda.gov, 21 Mar. 12). the specification of the drug Evon, manufactured by our company was according to the FDA guidelines. However the storage conditions in which Evon is recommended was not being followed for the last batch produced. It was not stored in proper refrigeration due to which the drug lost its properties and can become potentially harmful to the patients requiring it.

The batch was recalled when the problem was identified and now strict measures regarding quality control are being followed.

It is necessary to understand that the medicine industry is highly regulated instigation of proper quality controls at all levels from formulation to testing to approval to storage. A quality control management system or QCMS must be established on high standards, covering the aspects of drug sampling, testing and analysis. The analysis of the drugs must be of pre as well as post marketed products. Proper documental evidence of all the ...