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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

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 first 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.

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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