ISO 9000, TQM and the Pharmaceutical Industry

Paper Summary:

The total quality movement has one core idea: Products and services must achieve the highest attainable quality; in fact, nothing less will do. As a result, the two past decades or so have seen the rise of a philosophy aimed at maximizing organizational quality. The use of existing world standards for quality control, such as the standards in the ISO 9000 series, can help organizations achieve these goals, but there are some constraints to the process that must be resolved before the maximum benefits of such approaches can be realized. These comprehensive and extensive standards are differentiated by generic product categories and sectors and provide general quality control principles for all manner of products and services. This paper hypothesizes that the ultimate success of a company's ISO program will not depend solely on how well defined its quality system is, but rather its commitment to maintaining GMP. The study is defined as exploratory in nature with aim to provide an insight into previous research on these topics. Chapter one provides an introduction and overview. Chapter two provides a comprehensive review of the scholarly and peer-reviewed literature; chapter three presents the study's methodology and data-gathering method, followed by a statistical analysis of the survey findings in Chapter Four. A summary of the research, conclusions and recommendations are provided in the concluding chapter.

Outline
Abstract
Key Word Definitions
Chapter 1: Introduction
Background and Overview
Importance of Study
Preliminary Literature Review
Methodology and Research Questions
Rationale
Summary
Chapter 2: Review of the Relevant Literature
Chapter 3: Methodology
Description of the Study Approach
Data-Gathering Methods and Database of Study
Chapter 4: Data Analysis
Chapter 5: Summary, Conclusions and Recommendations
Bibliography
Appendix A

From the Paper:

"To accomplish this goal, a TQM system can direct a company's resources to operate in union with improved efficiency in satisfying customer needs and thus achieving higher profitability. Good manufacturing practices (GMP) are regarded as a part of the Quality Control System for companies producing pharmaceutical products (Lorsch, 1986). GMP principles seek to ensure the regular production for products that confirm with the health standards required from regulatory bodies. GMP provides the general basics to determine the minimum acceptable requirements for the production at good products, covering all the activities related to the production process. There has been a great deal of confusion concerning whether being in compliance with the pharmaceutical GMP would successfully lead to obtaining ISO certification, with minimum changes and costs), or whether achieving ISO certification is going to be a long and expensive road."

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