**Meet the editor**

Dr. Ahmed Badr Eldin is currently employed at Sigma Pharmaceutical Corp., Egypt. As a Methodology Manager he performs analytical methods development, stability, validation and auditing functions. The position is supported with his academic study through Masters degree in analytical chemistry, Zagazig University, Certified Quality Manager from ASQ - USA, Total Quality Management diploma from the American University in Cairo and Certified auditor for ISO 9001 QMS by IRCA. His academic and work experience has taught him how to analyze and evaluate problems, communicate effectively with a wide range of people, make decisions and use organizational administrative skills.

Contents

**Preface IX** 

**Part 1 Quality, General Definitions 1** 

Chapter 3 **GLP: Good Laboratory Practice 35** 

**Part 2 Evaluating Analytical Data 57** 

**Quality Control and Comparability** 

N. Phaswana-Mafuya, A. S. Davids,

**for Hot-Mix Asphalt Infrastructure:** 

Jordy Coffa and Joost van den Berg

**Health Care Services in a Selected District** 

**Quality Control-Quality Assurance Sampling;** 

Chapter 4 **Partitioning Error Sources for** 

James B. Stribling

Chapter 5 **Patient Satisfaction with Primary** 

I. Senekal and S. Munyaka

Chapter 6 **Application of Sampling Strategies** 

Chapter 7 **Analysis of MLPA Data** 

Ahmed Badr Eldin

Chapter 2 **Evaluating Quality** 

Isin Akyar

Chapter 1 **IA-Quality - General Concepts and Definitions 3** 

**Control Decisions: A Simulation Approach 15**  Mohamed K. Omar and Sharmeeni Murugan

**Analysis in Biological Monitoring and Assessment 59** 

**Municipality of the Eastern Cape of South Africa 85** 

**Specification for Performance Test Requirements 99**  Bor-Wen Tsai, Jiangmiao Yu and Carl L. Monismith

**Using Novel Software Coffalyser.NET by MRC-Holland 125** 

## Contents

## **Preface** XIII


Bor-Wen Tsai, Jiangmiao Yu and Carl L. Monismith

#### **Part 3 Quality Control for Biotechnology 151**

Chapter 8 **Establishment and Quality Control Criteria for Population Culture Collection - Promising Strategy for Animal Genetic Resource Preservation 153**  Yuehui Ma, Weijun Guan, Xiangchen Li, Xiaohong He, Yabin Pu, Qianjun Zhao, Dapeng Jin, Shen Wu, Taofeng Lu, Xiaohua Su and Chunyu Bai

Contents VII

Chapter 18 **Blood Irradiation 335**  Sezer Saglam

**Part 6 Examples for Different Quality Control Processes 349** 

**with Niprifan® Antifungal Phytomedicine 367** 

Sunday J. Ameh, Obiageri O. Obodozie, Mujitaba S. Abubakar,

Giuseppe Vermiglio, Giuseppe Acri, Barbara Testagrossa,

**the Experiences of a Public Health Laboratory 415**

**System for Defect Detection in Wood Laminates 439**  David Martin, Maria C. Garcia-Alegre and Domingo Guinea

**on Performance Capacity of Researching Technique,** 

Juan C. Rodríguez-Gamboa, E. Susana Albarracín-Estrada

**Using Digital Image Processing Techniques 523** 

**Exemplified by the Electron Probe X-Ray Microanalysis 477**

**From Time and Motion Study to Business Modeling 405**  Sachiko Shimizu, Rie Tomizawa, Maya Iwasa, Satoko Kasahara, Tamami Suzuki, Fumiko Wako, Ichiroh Kanaya, Kazuo Kawasaki,

Chapter 19 **R&D: Foundation Stone of Quality 351**  Petr Košin, Jan Šavel and Adam Brož

Magaji Garba and Karnius S. Gamaniel

Federica Causa and Maria Giulia Tripepi

Atsue Ishii, Kenji Yamada and Yuko Ohno

Francesc Centrich, Teresa Subirana, Mercè Granados and Ramon Companyó

Chapter 24 **Laser Diffuse Lighting in a Visual Inspection** 

Chapter 26 **Dependence of Determination Quality** 

and Edilson Delgado-Trejos

Mouloud Adel and Monique Rasigni

Chapter 28 **Mammographic Quality Control** 

**for Mean Times Between Failures 453** Yefim Haim Michlin and Genady Grabarnik

Chapter 27 **Quality Control Through Electronic Nose System 505**

Chapter 21 **Procedures for Evaluation of Slice Thickness in Medical Imaging Systems 383** 

Chapter 22 **Nursing Business Modeling with UML:** 

Chapter 23 **Practical Quality Control:** 

Chapter 25 **Comparison Sequential Test** 

Liudmila Pavlova

Chapter 20 **Herbal Drug Regulation Illustrated** 

Chapter 9 **Genomic Microarray Quality Assurance 167**  Catherine D. Kashork, Lisa G. Shaffer and Kyle S. Sundin

## **Part 4 Planning for Quality Control 179**

	- **Part 5 Quality Control for Medical Research and Process 207**

Chapter 18 **Blood Irradiation 335**  Sezer Saglam

VI Contents

**Part 3 Quality Control for Biotechnology 151**

Chapter 8 **Establishment and Quality Control Criteria** 

Chapter 9 **Genomic Microarray Quality Assurance 167**

**Part 4 Planning for Quality Control 179**

Chapter 10 **QA/QC in Transport** 

Chapter 12 **Quality Control and**

Edmundo Stahl

Javier Arrieta

Chapter 16 **Dose Optimization for** 

Mana Sezdi

Shahid Pervez

Chapter 17 **Infectious Aetiology of Cancer:** 

Filippo G. Praticò

**for Population Culture Collection - Promising** 

**Strategy for Animal Genetic Resource Preservation 153** Yuehui Ma, Weijun Guan, Xiangchen Li, Xiaohong He, Yabin Pu, Qianjun Zhao, Dapeng Jin, Shen Wu, Taofeng Lu, Xiaohua Su and Chunyu Bai

Catherine D. Kashork, Lisa G. Shaffer and Kyle S. Sundin

**Infrastructures: Issues and Perspectives 181** 

**Part 5 Quality Control for Medical Research and Process 207**

**in Clinical Laboratory Accredited by ISO 15189 209**  Silvia Izquierdo Álvarez and Francisco A. Bernabeu Andreu

**Quality Assurance in Human Experimentation 229**

**for Medical Processes, Through Epidemiological Trends of Medical Conditions, to a Nationwide Health Project 259** Yossy Machluf, Amir Navon, Avi Yona, Avinoam Pirogovsky, Elio Palma, Orna Tal, Nachman Ash, Avi Cohen and Yoram Chaiter

**Breast Cancer Society in Regional Medical Activities 283** 

Chapter 13 **Quality and Quality Indicators in Peritoneal Dialysis 245** 

**Registered Breast Specialist of the Japanese**

Noriyuki Tohnosu, Jun Hasegawa, Yosio Masuda,

**the Quality Control Tests of X-Ray Equipment 295** 

Taku Kato, Satoru Ishii and Kanae Iwata

**Developing World Perspective 319**

Chapter 11 **Procedures for Validation of Diagnostic Methods** 

Chapter 14 **From a Quality Assurance and Control System** 

Chapter 15 **The Significance of Board-Certified** 


Preface

manufacturing process.

techniques and procedures.

Our pharmaceutical and medical organizations are living organisms need feeding, growth and development to be competitive and can strive to survive otherwise it will degenerate by the tough competition from the surroundings. Quality is a major tool for agile and competitive organization. Quality need to be monitored and to be built into the product so it needs quality control which need highly accurate, precise, sensitive and valid analytical procedures to judge the quality throughout the

Rapid advance have been made in the last decade in the quality control procedures and techniques, most of the existing books try to cover specific techniques with all of their details. The aim of this book is to demonstrate varieties of quality control processes in pharmaceutical and medical fields. We have covered wide range of

We have started from general definitions and basic information about quality, good laboratory practices, decision in Q.C, evaluation of the Q.C data, planning for Q.C. then we have gone through a varieties of quality control issues which are helpful for

> **Dr. Ahmed Badr Eldin**, Sigma Pharmaceutical Corp.,

> > Egypt

different workers in the pharmaceutical and medical field.

## Preface

Our pharmaceutical and medical organizations are living organisms need feeding, growth and development to be competitive and can strive to survive otherwise it will degenerate by the tough competition from the surroundings. Quality is a major tool for agile and competitive organization. Quality need to be monitored and to be built into the product so it needs quality control which need highly accurate, precise, sensitive and valid analytical procedures to judge the quality throughout the manufacturing process.

Rapid advance have been made in the last decade in the quality control procedures and techniques, most of the existing books try to cover specific techniques with all of their details. The aim of this book is to demonstrate varieties of quality control processes in pharmaceutical and medical fields. We have covered wide range of techniques and procedures.

We have started from general definitions and basic information about quality, good laboratory practices, decision in Q.C, evaluation of the Q.C data, planning for Q.C. then we have gone through a varieties of quality control issues which are helpful for different workers in the pharmaceutical and medical field.

> **Dr. Ahmed Badr Eldin**, Sigma Pharmaceutical Corp., Egypt

**Part 1** 

**Quality, General Definitions** 
