12.4.1 NABL Vision 187

12.4.2 NABL Mission 187

12.4.3 Achievements of NABL (As per the Official Website of NABL) 188

12.4.4 Scope of NABL Accreditation 188

12.4.5 Benefits of Accreditation 189

Long Answer Type Questions 190

Short Answer Type Questions 190

Objective Type Questions 190

Summary 193

xvi Industrial Pharmacy II

UNIT 5: Indian Regulatory Requirements

13. Central and State Drug Regulatory Authority of India 206

13.1 Drug Regulatory Authority 206

13.2 Central Drug Standard Control Organisation (CDSCO) 208

13.3 State Licensing Authorities (SLA) 212

Long Answer Type Questions 213

Short Answer Type Questions 213

Objective Type Questions 213

14. CTD and New Drug Approval Process in India 215

14.1 Common Technical Document 215

14.2 Certificate of Pharmaceutical Product (COPP) 217

14.3 New Drug Approval in India 218

Requirements for New Drug Approval 220

Long Answer Type Questions 221

Short Answer Type Questions 221

Objective Type Questions 222

Summary 224

Index 229

1. Introduction to Pilot-Plant and Scale-up

2. General Considerations and Pilot-Plant Considerations

for Different Dosage Forms

3. SUPAC Guidelines and Platform Technology

Summary

1