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New Book

This book is on “Pharmaceutical Quality Assurance” meant for

Master of Pharmacy (M. Pharm.) and Bachelor of Pharmacy

(B. Pharm.) students. The book presents the basic concepts of Total

Quality Management (TQM), Good Manufacturing Practices (GMP),

Good Laboratory Practices (GLP), Validation and Calibration. It

describes detailed guidelines on GMP, GLP and Validation for

pharmaceuticals.

The book consists of four chapters, question bank and supporting

material. The rst chapter deals with concepts and philosophy of

TQM, GMP and GLP. The second chapter discusses the guidelines on

Good Manufacturing Practices (GMP) for pharmaceuticals. The

third chapter describes guidelines on Good Laboratory Practices

(GLP) useful in the testing of drugs and pharmaceuticals. Detailed

guideline on validation is presented in the fourth chapter. Important questions and answers on each

chapter are provided in the question bank. The supporting material gives additional sources of learning

to the readers in the form of glossary, points to ponder, did you know? and web links/ further reading.

Contents

1. Basic Concepts of Quality Assurance - 1.1 Pharmaceutical quality assurance; 1.2 Quality

control; 1.3 Total quality management; 1.4 NABL accreditation; Question bank; Web links/

further reading.

2. Good Manufacturing Practices - 2.1 Concepts and philosophy of GMP; 2.2 Organisation and

personnel; 2.3 Premises; 2.4 Equipments; 2.5 Raw materials; 2.6 Manufacture of and controls on

dosage forms; 2.7 In process quality controls (IPQC) of sterile and non-sterile dosage forms; 2.8

Standard operating procedures (SOPs); 2.9 Packaging and labelling control; 2.10 Good

warehousing practices; 2.11 Materials management; 2.12 Finished products release; 2.13

Distribution records; 2.14 Complaints and recalls; 2.15 Waste and scrap disposal; Question bank;

Web links/ further reading.

3. Good Laboratory Practices - 3.1 Concepts and philosophy of GLP; 3.2 Quality control

laboratory; 3.3 Non-clinical laboratory study; 3.4 Quality audit; Question bank; Web links/ further

reading.

4. Validation and Calibration - 4.1 Basic concepts of validation and calibration; 4.2. Analytical

method validation; 4.3 Calibration; Question bank; Web links/ further reading.

Pharmaceutical

Quality AssuranceDr. B. P. Nagori, Dr. Ajay Gaur & Dr. Renu Solanki

ISBN: 978-93-86652-01-0| 2017 | 275 pages | August, 2017

Best Selling Book Herb - Pharmacy

Thousands of safe, natural remedies lie untapped in jungles, forests and

herbal gardens throughout the world. Now America's foremost authority

on medicinal plants and herbs shares his knowledge of these hidden

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pressure, with none of the side effects of prescription drugs.

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cholesterol-lowering power than oat bran.

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monster headaches.

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serotonin.

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depletion.

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but costs only pennies.

The Green PharmacyJames A. Duke

Reviews

"The Green Pharmacy is full of helpful, practical information about using plants as medicines... I plan to

consult it often." – Dr. Andrew Weil

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traditions... A treasure house of practical advice for the newcomer and pearl's of wisdom for the herbal

practitioner." – Joseph E. Pizzorno, N.D., President of Bastyr University, Seattle, and author of Total

Wellness

"If you are bewildered by all the books that have been published on herbal healing, this is the one to

buy!" – Mark J. Plotkin, Ph.D., Ethnobotanist and author of Tales of a Sharman's Apprentice

"Filled with gene of wisdom -- a treasure of information from a man who knows as much as anyone in the

world about medicinal plants. – Jean Carper, bestselling author of Miracle Cures

"Jim Duke was the rst to pioneer the concept of food as drugs and back it up with rst-class research.

Now Jim has written the ultimate guide, The Green Pharmacy. In our home, we've followed Jim's

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"America's ̀ herbal laureate' has done it again! Jim Duke has brought his energy, enthusiasm, expertise

and genius to the pages of The Green Pharmacy. Fascinating reading for anyone interested in health

care and herbs." – Michael Balick, Director of the Institute of Economic Botany at the New York

Botanical Garden.

2nd Reprint in India, ISBN: 978-81-7233-313-3 | 2017 | 508 pages | Stud. Ed. | ` 950