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Quality Assurance Techniques in Pharmaceuticals (Hardback, V.M.Waghulkar (Thakare),Dr. (Prof.) K.K. Tapar & Dr. (Prof.) V.N. Shrikhande: )

Brand: NIPA

Inclusive of all taxes

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

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Brand: NIPA

Country of Origin: India

In this era of quality assurance, it is imperative that every organization strives for quality in order to achieve its objectives. This book has been prepared with the aim of providing basic techniques, methods, plans, and certification procedures for quality assurance, with the syllabus laid out by various Indian universities in mind. 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.

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.


Contents 


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



Books

NIPA books

Quality Assurance

Pharmaceuticals

Master Of Pharmacy

ISO Standards

GMP

PAT

SUPAC

Validation Techniques

Pharmaceutical Guidelines

Quality Management

Quality Assurance Techniques in Pharmaceuticals (Hardback, V.M.Waghulkar (Thakare),Dr. (Prof.) K.K. Tapar & Dr. (Prof.) V.N. Shrikhande: )

Brand: NIPA

Inclusive of all taxes

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