A DYNAMIC APPROACH IN PHARMACEUTICAL QUALITY ASSURANCE
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TypePrint
- CategoryAcademic
- Sub CategoryText Book
- StreamMedical Science, Pharmaceutical & Nursing Sciences
Now-a-days, Pharmaceutical companies are facing many problems regarding quality of product as it is very important to maintain quality of any pharmaceutical product throughout their lifecycle to compete with other manufacturers in the market. In addition, it is also concern with public’s health. Technical knowledge about pharmaceuticals is only basis for how to manufacture a medicine but other practical criteria and strategies should be understood by the students to achieve good quality product. Hence, it is author’s opinion that student should have basic knowledge of company’s organization, facilities and manufacturing and quality control for raw materials, packaging materials and finished pharmaceutical products. For that purpose author have included GMP guidelines and ISO standards for achieving best quality of product. The object of writing this book was to provide a text book which contains basic fundamentals related quality control and quality assurance in pharmaceutical industries and also at low cost which includes all approaches to maintain and improve quality of product by the manufacturer. It will help students of under graduation and post-graduation of pharmacy field in future to start up a business with maximum profit. In 1st chapter of this book, general concept of quality control and quality assurance is explained and ICH quality guidelines are discussed. ISO standards also included. In 2nd, 3rd and 4th chapter, GMP guidelines are discussed. In 5 th chapter quality control tests for packaging materials are given. GLP guidelines for laboratory animal studies are discussed in chapter 6. Handling of complaints for pharmaceutical products are also included by industry.as chapter 7. In addition, scope of documentation and formats for different types of documents to be maintained in pharmaceutical industry are also incorporated as chapter no. 8. Calibration and validation for manufacturing and analytical processes are explained in chapter 9. Finally, chapter 10 is about good warehousing practices and material management in pharmaceutical industry. Charts and figures appropriate to the content are also added within the book. In short, in an effort to present complete coverage of quality assurance, above basic topics are covered in this book.
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