Table of contents (13 chapters)
Front Matter
Pages i-viii
Introduction: Quality Assurance from Perspective of Pharmaceutical Industry
Minal Ghante, Shrikant Dargude, Arpana Patil, Vidhya Bhusari
Pages 1-7
Six Sigma Model in Pharma Industry: Part – I
Minal Ghante, Shrikant Dargude, Vishal Zambre, Sanjay Sawant
Pages 9-19
Six-Sigma Model in Pharma Industry: Part – II
Minal Ghante, Shrikant Dargude, Vishal Zambre, Sanjay Sawant
Pages 21-50
Developing a Practical Audit System for a Pharmaceutical Industry Based on Six System Inspection Model
Aishwarya Pawar, Manohar Potdar, Gaurav Malbhage, Vidhya Bhusari, Minal Ghante, Vandana Nikam
Pages 51-72
Compliance Tools to Assist the Drug Industry for Regulatory Audits from Developed Countries
Simran Shaikh, Manohar Potdar, Prem Goel, Akansha Lonkar, Minal Ghante
Pages 73-91
Developing an Application Model for Planning, Controlling, Improving, and Assuring Quality for Pharmaceutical Industry: Covering Quality Planning and Quality Control
Swati Bargal, Manohar Potdar, Rinku Dey, Vidhya Bhusari
Pages 93-166
Developing an Application Model for Improving Quality of Pharmaceutical Manufacturing Based on the Quality Principles – Covering Quality Improvement and Quality Assurance Audit
Vidhya Bhusari, Manohar Potdar, Raskar Madhuri, Akansha Lonkar
Pages 167-227
Developing a Design Qualification Protocol as Standard Operating Procedure for a Pharmaceutical Plant Facility Meeting cGMP Requirement for Tablets and Capsules Manufacturing Department
Vidhya Bhusari, Manohar Potdar, Pratiksha Nandalwar, Prayas Warbhe, Minal Ghante
Pages 229-326
Developing a Design Qualification Protocol as Standard Operating Procedure for a Pharmaceutical Plant Facility Meeting cGMP Requirement for Liquid Oral and Ointment Department
Vidhya Bhusari, Manohar Potdar, Pragati Sawkar, Monika Jadhav, Minal Ghante
Pages 327-362
Developing a Simplified Model Standard Operating Procedure to Implement Quality Metrics for Pharmaceutical Manufacturing System
Manohar Potdar, Madhuri Hivrale, Neha Bhavare, Rohan Thosar, Supriya Jagtap
Pages 363-380
Documentation and Data Integrity in Pharmaceutical Industry
Preeti Kulkarni, Charmy Kothari
Pages 381-403
Quality Risk Management
Abhay Walvekar, Akash Ambhore, Rahul Bankar, Shital Godse
Pages 405-443
Deviation, Change, Control, and CAPA
Abhay Walvekar, Rahul Bankar, Sayaji Patil, Priti Kalghuge, Vasundhara Sawant
Pages 445-523
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