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This handbook covers compliance with good manufacturing practices (GMPs), as regulated and guided by national and international agencies for the pharmaceutical industry. It covers finished human and veterinary drugs and biologics, and combination devices, as well as their component raw materials (including active pharmaceutical ingredients (APIs) and excipients), and packaging and labeling operations.

The provided solutions are taken from the same references used by the ASQ Item Writing teams who create the test items used in the formal Six Sigma Yellow Belt Certification examination.

The CD accompanying the print book and at the end of the e-book versions includes a practice problem set covering each part of the book and a simulated examination that has problems distributed among parts according to the scheme published in the Body of Knowledge.

This book makes the reader familiar with the objectives of project planning and various phases of projects. This book deals with the planning of the project with references to phases of capital budgeting and levels of decision making in an organization. It explains the various project charts and layout and also gives the details of the work schedules. It deals with the topic like project life cycle, project selection, feasibility study, and techniques like PERT and CPM. The techniques of project risk analysis and financial analysis have been discussed in detail with the help of sufficient numerical examples. It also contains the administrative aspects of capital budgeting and issues involved in project review. Most importantly the book includes several chapter-end problems and questions to test students’ understanding of the subject. The main thrust of the book has been to bring home the concept clearly in the minds of readers.

This handbook covers compliance with good manufacturing practices (GMPs), as regulated and guided by national and international agencies for the pharmaceutical industry. It covers finished human and veterinary drugs and biologics, and combination devices, as well as their component raw materials (including active pharmaceutical ingredients (APIs) and excipients), and packaging and labeling operations.

In an unconventional and intriguing manner the author addresses the economics of quality, statistical thinking, statistical process control, and inspection efficiency. He provides a useful process model for achieving a continuous improvement state in any organization.

As the author is quick to say, “This is not a cookbook! It is, however, a book about cooking.”