2.5 Documentation 21

Long Answer Type Questions 23

Short Answer Type Questions 23

Objective Type Questions 23

UNIT 1: Pilot-Plant Scale-up Techniques

xii Industrial Pharmacy II

3. SUPAC Guidelines and Platform Technology 25

3.1 Purpose of Guidance 25

3.2 Evolution of SUPAC Guidance 25

3.3 Terminologies used in Guidance Document 26

3.4 Level of Changes 28

3.5 Type of Changes 28

3.6 Introduction to Platform Technology 37

Long Answer Type Questions 39

Short Answer Type Questions 39

Objective Type Questions 39

Summary 41

UNIT 2: Technology Development and Transfer

4. Technology Development and Transfer 50

4.1 Technology 50

4.2 Technology Development 50

4.3 Technology Transfer 50

4.4 Technology Transfer in Pharmaceutical Sciences 51

4.4.1 Reasons for Technology Transfer 54

4.4.2 Types of Technology Transfer 55

4.4.3 Methods of Technology Transfer 56

Long Answer Type Questions 57

Short Answer Type Questions 57

Objective Type Questions 57

5. WHO Guidelines for Transfer of Technology 60

5.1 Introduction 60

5.2 Transfer of Technology (TOT) as per WHO 60

5.3 Scope of WHO Guidelines for TOT 62

5.4 Terminologies Source 62

5.5 Organisation and Management 66

5.6 Quality Risk Management 68

5.7 QRM Application in Pharmaceuticals 72

5.8 Transfer from R&D to Production (Process, Packaging and Cleaning)

and Granularity of TT Process (API, Excipients, Finished Products,

Packaging Material) 74

5.9 Analytical Method Transfer 79

5.10 Premises and Equipment 81

5.11 Documentation 84

5.12 Qualification and Validation 84

Long Answer Type Questions 85

Short Answer Type Questions 85

Objective Type Questions 85

Contents xiii

6. Regulation of Transfer of Technology 87

6.1 Authorities and Agencies Involved in TOT 87

6.2 Problems Faced During Commercialisation 89

6.3 Case Studies of Technology Transfer 90

6.4 TOT Agencies in India 91

6.4.1 APCTT 91

6.4.2 NRDC 93