Description
Ane Books Pvt. Ltd. Pharmaceutical Quality Assurance by M Aamir Mirza
Pharmaceutical Quality Assurance (BP 606 T as per the PCI syllabus) serves as a comprehensive guide for students and professionals, offering an in-depth understanding of the principles and practices which ultimately ensures the quality, safety, and efficacy of pharmaceutical products. This textbook is meticulously designed to address both foundational concepts and advanced topics, making it suitable for academic and professional purposes.
Key features of the book include:
• Comprehensive Coverage
• Regulatory Insights
• Practical applications and real-world examples
• Advanced Tools and Techniques
• Illustrative figures and diagrams wherever require
• Different types of questions like MCQs, short and long answer types
Written in a clear and engaging style, this textbook is an invaluable resource for undergraduate and postgraduate students in pharmaceutical sciences, and related fields. It also serves as a reliable reference for professionals striving to maintain the highest standards of quality in pharmaceutical development and manufacturing.
Contents
1. Quality Assurance and Quality Management
2. Organization, Premises, Equipment and Raw Materials
3. Quality Control and GLP
4. Complaints
5. Calibration, Validation and Warehousing
Authors
Dr. M. Aamir Mirza is working in the Department of Pharmaceutics, School of Pharmaceutical Education and Research (SPER), Jamia Hamdard, an NIRF Rank 1 institute and a NAAC ‘A+” grade deemed to be University. He has a multifaceted career portfolio adorned with both industry and academic accomplishments. During his industry stay he became a seasoned scientist and dealt with challenging NCE/NDA development. He is on advisory boards of some international research-based companies of India, New Zealand and Europe. Academics and Research being close to his heart, he has published more than 100 manuscripts in the journals of international repute and has been granted 02 Indian patent and filed for 04. He has contributed several chapters in books published by reputed authors like Elsevier and Bentham. He is amongst the very few scientists globally who has an expertise in Humic substances research. A well-travelled scientist; he has delivered scientific addresses in countries like USA, Austria, Japan, Netherlands, Turkey, Estonia, Spain and Russia.
The author Prof. (Dr.) Zeenat Iqbal is working at the Department of Pharmaceutics, School of Pharmaceutical Education and Research (SPER), Jamia Hamdard, an NIRF Rank 1 institute and a NAAC ‘A” grade Deemed to be University. She has earned her doctorate in Pharmaceutics from Jamia Hamdard. An active research supervisor with h-index of 38, 180 journal publications, and 25 books/chapters. she has also co-authored three books encompassing pharmaceutical technology and Pharmaceutical Regulatory Affairs and has one patent granted in her name with three patents co-filed. She has organized around numerous workshops, conferences and has been invited for around 75 oral and scientific presentations. She has been the coordinator for e-PG PathShala, MHRD, Government of India. She has won a number of awards and is a life member of professional bodies like IPA, IPGA, ISAS, APA and NESA. She has been granted several research projects by the government agencies and industries.