The pharmaceutical quality system ensures that the process performance is suitably achieved, the product quality is regularly met, improved opportunities are identified and evaluated, and the knowledge is constantly expanded. Auditing also plays a crucial role within the pharmaceutical industry. It helps to assess and review quality to improve and build a better system for the benefit of companies.
This book aims to develop a tool that will substantially decrease the number of Inspectional Observations and Warning letters, thus eliminating Import Alerts and Consent Decree. This book targets the Pharmaceutical Industry and students of Pharmaceutical Quality Assurance so they can get in hand-ready consolidated information on Pharmaceutical Quality guidelines, Quality metrics, and implementation of simplified SOP guidelines, plant layouts to implement Quality metrics for Pharmaceutical Manufacturing systems in tablets, capsules, liquid orals, and semi-solid dosage forms.
The chapters cover the various aspects of Pharmaceutical Quality Assurance. The selection of topics is mainly based on the requirements of Pharmaceutical regulatory guidelines of India, the UK, the USA, Australia, and South Africa. Each chapter includes the abstract, detailed explanation, implementation guidelines, flowcharts, layouts, and Standard Operating Procedure of quality metrics for the Pharmaceutical Manufacturing System
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
