About the Book

The book deals with various aspects of quality control and quality assurance systems as followed in pharmaceutical industries. Quality assurance deals with the sum of all activities and responsibilities required to ensure that the medicines that reached the patients are safe, effective, and of good quality. The topics has been discussed in depth according to the B. Pharm syllabus as framed by Pharmacy Council of India (PCI) for the students, hence the textbook has been written keeping in mind the urgent need.

 Efforts have been made to describe the important aspects like cGMP, QC tests, documentation and record keeping, quality certifications, regulatory needs and guidelines, etc., in systematic and comprehensive manner.

 The topics has been illustrated with flow charts, tables and figures, wherever, felt necessary. Each chapter has been divided into introduction, background, objectives, principles, elements, description,
organization, concepts and documentation in a thorough manner.

 The book has been written keeping in view the requirements of the graduate, post graduate students, teachers and research scientists as per the latest updations.

 Quality Assurance and Quality Management Concepts
 Total Quality Management
 ICH (Guidelines)
 Quality by Design
 International Standard Organization (ISO)
 National Accreditation Board for Testing and Calibration Laboratories (NABL)
 Organization and Personnel
 Buildings and Facilities (Premises)
 Process Equipment and Raw Materials
 Quality Control of Packaging Material
 Good Laboratory Practices (GLP)
 Complaints
 Document Maintenance in Pharmaceutical Industry
 Calibration and Validation
 Good Warehousing and Distribution Practices