med 18

 

11.2 Quality by Design 164

11.2.1 Designing of Product/Process as per QbD Has Following

Requirements 164

11.2.2 Benefits of QbD: QbD Helps in 165

11.2.3 Scope of QbD 165

11.2.4 Steps in Quality by Design Approach 165

11.2.5 Importance of Quality by Design in Pharmaceuticals 168

Contents xv

11.3 Six Sigma Concept 169

11.3.1 Characteristics of Six Sigma 169

11.3.2 Objectives of Six Sigma 170

11.3.3 Levels of Six Sigma 170

11.3.4 Six Sigma in Pharmaceuticals 171

11.4 Out of Specifications 171

11.4.1 Reasons for OOS 171

11.4.2 OOS Investigation 172

11.5 Change Control 174

11.5.1 Elements of Change Control 175

11.5.2 Classification of Changes 175

11.5.3 Motives of Change Control 175

11.5.4 Barriers in the Way of Effective Change Control 176

11.5.5 Regulatory Concerns/Requirement for Changes 176

Long Answer Type Questions 176

Short Answer Type Questions 176

Objective Type Questions 177

12. ISO Series, NABL and GLP 180

12.1 ISO 9000 Series 180

12.1.1 Standards within ISO 9000 181

12.1.2 Quality Principles 181

12.1.3 Steps in Obtaining ISO 9000 Series Certification 182

12.1.4 Advantages of Obtaining ISO 9000 Certification 182

12.1.5 Barriers in Implementing Efficient IS0 9000 Guidelines in an

Organisation 182

12.2 ISO 14000 Series 183

12.2.1 Aim of ISO 14000 Series (as per ISO) 183

12.2.2 Model of ISO 14000 Series 184

12.3 GLP: Good Laboratory Practice 185

12.3.1 History 185

12.3.2 Scope of GLP 186

12.3.3 Fundamentals of GLP 186

12.3.4 Objectives of GLP 187

12.4 National Accreditation Board for Testing and Calibration Laboratories

(NABL) 187