TABLE OF CONTENTS



TABLE OF CONTENTS

|Sec. No. |Title |Page |

| |List of Abbreviations |xi |

| |Abstract in English |xiii |

| |Abstract in Arabic |xv |

|. |Chapter One: Introduction | |

|1.1 |Overview |2 |

| 1.1.1 |Costs and Benefits of Quality |5 |

| 1.1.2 |Impact of Quality on competitiveness |11 |

|1.2 |Purpose of The Study |14 |

|1.3 |Problem Statement |15 |

|1.4 |Importance of the study |16 |

|1.5 |Palestinian Pharmaceutical Industry as a focus of the study |18 |

| 1.5.1 |History |18 |

|1.5.2 |The Development of Palestinian Pharmaceutical Industry |19 |

|1.5.3 |Palestinian Pharmaceutical Industry toward Complying with GMP |22 |

|1.5.4 |Role of Palestinian MOH in Pharmaceutical Regulations |24 |

|1.6 |Limitations |26 |

|1.7 |Organization of the study |27 |

|1.8 |Definition of Terms |28 |

| |Chapter Two: Literature Review | |

|2.1 |The Role of Quality Management In Pharmaceutical Industry |33 |

|2.2 |Costs and Benefit of Quality |36 |

|2.3 |Quality and Competitive strategy |44 |

|2.4 |Studies about Palestinian Pharmaceutical Industry |48 |

| |Chapter Three: Pharmaceutical Regulations & standards | |

|3.1 |Introduction |52 |

|3.2 |The Concept of regulatory Standards |56 |

| 3.2.1 |Good Laboratory Practices (GLP) |56 |

| 3.2.2 |Good Clinical Practices (GCP) |56 |

| 3.2.3 |ISO 9000 & ISO 14000 |57 |

|3.3 |The concepts of Quality Assurance, GMP, and Quality Control |63 |

| 3.3.1 |Quality Assurance |64 |

|Sec. No |Title |Page |

| 3.3.2 |Good Manufacturing Practice for Medicinal Products (GMP) |66 |

| 3.3.3 |Quality Control |68 |

|3.4 |Relationship between ISO 9000 and GMP compliance |72 |

| |Chapter Four: Research Methodology | |

|4.1 |Introduction |76 |

|4.2 |Research methodology selection |76 |

|4.3 |Research tools |77 |

| 4.3.1 |Questionnaire design |77 |

| 4.3.2 |Face to Face Interview |78 |

| 4.3.3 |Study Population & Sample |79 |

|4.4 |Goodness of data |80 |

| 4.4.1 |Validity |80 |

| 4.4.2 |Reliability |80 |

| 4.5 |Hypothesis |81 |

| 4.6 |Data Analysis |81 |

| 4.6.1 |Data Management |81 |

| 4.6.1.a |Data Editing |81 |

| 4.6.1.b |Data Entry |81 |

| 4.6.2 |Statistical Analysis |82 |

|4.7 |Hypothesis Testing |82 |

| |Chapter Five: Finding and Results | |

|5.1 |Introduction |86 |

|Sec. No |Title |Page |

|5.2 |Respondents Companies, Positions, and Departments |87 |

|5.3 |Quality concept and management commitment for improving quality |88 |

|5.4 |Cost of Quality related to employees' resistance |90 |

|5.5 |Tracking the Cost of conformance and Cost of Non- Conformance |92 |

|5.6 |Benefits of quality on cost, culture, productivity and performance, sales, and profits |93 |

|5.7 |Impact of quality on competitiveness |96 |

|5.8 |Reasons for complying with international standards and regulations |99 |

|5.9 |Hypothesis Testing |101 |

| 5.9. 1 |The main hypothesis testing |101 |

| 5.9.2 |The sub-hypothesis testing |103 |

|5.10 |Correlation between results |108 |

|5.11 |Findings of the Interview and other resources |110 |

| 5.11.1 |Findings of top management interviews |110 |

| 5.11.2 |Interview with pharmaceutical industry Experts |114 |

|5.12 |Conclusion |116 |

| |CHAPTER SIX: Conclusion and Recommendations | |

|6.1 |Introduction |118 |

|6.2 |Conclusion |120 |

| | | |

|6.3 |Recommendations |131 |

| 6.3.1 |Practical implications for Palestinian Pharmaceutical Companies |131 |

|Sec. No |Title |Page |

| 6.3.2 |Policy implications for Ministry of Health |136 |

|6.4. |Recommendations to other studies |137 |

|6.5. |Contribution to the theoretical knowledge |138 |

|6.6. |Contribution to the practical knowledge |139 |

| |References |141 |

| |Appendices |154 |

................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download