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The book 'Quality Assurance Techniques in Pharmaceuticals' authored by V.M. Waghulkar (Thakare), Dr. (Prof.) K.K. Tapar, and Dr. (Prof.) V.N. Shrikhande serves as a comprehensive guide for Master of Pharmacy students. It lays out essential quality assurance techniques and methodologies, framed according to the syllabi of various Indian universities. The text delves into crucial areas including Total Quality Management, ISO standards, Good Manufacturing Practices (GMP), and ICH guidelines, making it an indispensable resource for students aiming to enhance their knowledge and skills in pharmaceutical quality assurance. By focusing on cutting-edge approaches such as SUPAC (Scale-Up and Post approval Changes) and PAT (Process Analytical Technology), the book equips students with the necessary tools to develop robust quality assurance strategies and methodologies necessary for a variety of drug formulations. Whether understanding the fundamentals of quality assurance or familiarizing with advanced validation processes, readers will find this resource an invaluable addition to their academic and professional arsenal.
Key Features
Features | Description |
---|---|
Comprehensive Coverage | Covers essential techniques and methods of quality assurance in pharmaceuticals. |
University Syllabus Alignment | Content is structured according to the syllabus of various Indian universities. |
Modern Techniques Emphasis | Focus on SUPAC and PAT for advanced pharmaceutical practices. |
Certification Procedures | Detailed information on certification methods ensures compliance with regulations. |
Guidelines on Audit Quality | Includes relevant guidelines and practices for auditing in pharmaceutical quality. |
Attributes | Description |
---|---|
Authors | V.M. Waghulkar (Thakare), Dr. (Prof.) K.K. Tapar, Dr. (Prof.) V.N. Shrikhande |
Format | Hardback |
Target Audience | Master of Pharmacy students |
Main Topics Covered | ISO standards, GMP, Total Quality Management, Analytical Methods, Validation |
Publication Year | 2023 |
Key Words
*Disclaimer: This above description has been AI generated and has not been audited or verified for accuracy. It is recommended to verify product details independently before making any purchasing decisions.
Brand: NIPA
Country of Origin: India
The primary goal of this book is to provide master of pharmacy students with up-to-date knowledge of various quality assurance data, as well as the skills necessary to develop methods for a variety of drug combinations. Special emphasis is placed on modern techniques like SUPAC and PAT, as well as a thorough explanation of ISO, GMP, and ICH guidelines.
ContentsÂ
01. Basic Terminology Used In Quality Assurance 02. Total Quality Management 03. ISO 9001 : 2000 04. Environmental Management Systems and ISO 14000 05. GMP and GMP Compliance 06. Master Formula Record 07. Good Documentation Practices 08. Validation 09. Statistical Methods Used For Method Development 10. Analytical Method Development for Pharmaceutical Formulations 11. Guidelines on Audit Quality 12. ICH Harmonised Tripartite Guideline for Pharmaceutical Quality System
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