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Pharmaceutical Quality Assurance

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Pharmaceutical Quality Assurance

B.P. Nagori , Ajay Gaur , Renu Solanki & Vipin Mathur

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Blurb

The present state-of-art book has been written as per the new syllabus of B. Pharmacy, introduced by Pharmacy Council of India (PCI). This book has an inclusive content that covers the wider aspects of pharmaceutical quality assurance required by under- graduates, post graduates, industry personnels, researcher, and students preparing for various competitive exams. The distinguishing feature of this book is that the book is written in lucid, simple and easy to understand language. The book is accompanied with Multiple Choice, Fill in the Blank, True-False, Short Answer and Long Answer type of questions for the self- evluation of learning. The answers of the Multiple Choice, Fill in the Blank and True-False questions have also been given. Web links/further reading are included to help the readers for keeping themselves abreast with th latest developments in the held of pharmaceutical quality assurance. Academicians and instructors in universities/colleges may use the book as primary or additional teaching material for under-graduate and post-graduate pharmacy courses.

Prof. B. Suresh M. Pharm, Ph. D., D.sc

President

Combined Councils' Building  Kotla Road, Aiwan-E- Ghalib Marg  P.B. No. 7020, New Delhi- 110 002 

Phone : 01123239184, 23231348 Fax : 011 23239184

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

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