Quality Control Literature Reviews Samples For Students

Introduction

Pharmaceutical companies should create and follow a standard operating procedure by implementing a cleaning validation to ensure future patient safety. Validation has received great attention by the FDA in recent inspections. Manufacturers must validate their cleaning process to ensure compliance with GMP regulations 1. One of the main keys in the manufacturing of dosage formulation is to develop cleaning procedures that will remove all types of residues from the equipment and containers. The goal of Cleaning Validation is to ensure effectiveness in cleaning equipment, and to prevent pollution and cross contamination of drug products to ensure the quality, safety; efficacy and ...

Introduction

Ishikawa is ranked among the quality gurus. He played a significant role in introducing and improving quality controls in Japan’s industries immediately after World War II. He emphasized that customers were the core reason why businesses existed and should therefore be provided with quality products and follow up be done to ensure that they get satisfaction from those products (GURU GUIDE, 2010). He is also famed for coming up with the fish bone cause and effect diagram and the quality circle.

Background

Kaoru Ishikawa was born in 1915 in Tokyo as the oldest son in a household that had eight children. ...

Introduction

One among the fields that have profited from the rapid technological progress in the previous centuries is the field of medicine. Conditions and Diseases that scientists had trouble in understanding and curing are now cured successfully and with virtual ease. More people as well as the incurably-ill now survive longer than before. Development in the global population has been distinguished in the 20th century. The old and young population has increased pressure on medical care resources internationally with the intention that no nation is currently capable to compete with the demand for medical -care and its supply. Scientists hence ...

Abstract

Total quality management is an approach steeped in scientific management. It involves an attempt to cut down on defects and meet what consumers require of a firm. TQM is based on the formulation of a system to monitor and control affairs and set and meet quality targets through a generalist framework. This is done through several approaches and systems including Six Sigma, Toyota Production System and ISO-9001.
This paper focuses on ISO-9001. It is an accreditation system that is utilized by registering with a global monitoring system that is applied over an extended period of usually 6 months. ISO-9001 ...

Requirement for the Manufacture of Drugs concerning Public Safety

Abstract
The study will focus on pharmaceutical companies’ standard operation procedures. More in depth, the study will determine if cleaning validation and verification is a successful way to keep the quality of manufactured drugs at a high standard. The importance of the validation of a sterilization process will be examined. The study will list reasons for validation of sterilization through a set of regulatory expectations put in place by the FDA.
The regulatory expectations of the FDA will support the methods and analysis used to conduct this study. The study will also examine the success and failure of cleaning validation through ...