Contents

S.NO. PARTICULAR PAGE NO.

1.0 Introduction 1-15

1.1 Good manufacturing practice 1-2

1.2Guideline versions

2

1.3 Enforcement 3-4

1.4 Other good manufacturing practices 5

1.5 What is GMP?Regulation of the pharmaceutical 5

1.5A Introduction 6-8

1.5B The life cycle of pharmaceutical product 9-11

1.6 Validation 11

1.7 Master validation plan 12-13

1.8 Process validation 13

1.9 Quality Control 14

1.10 Total Quality Control 14

1.11 Quality Assurance 15

2.0 Veterinary dosage forms 21-22

2.8 Oral Dosage Forms 22-24

2.9 Topical Dosage Forms 24-25

3.0 Solid Doage Form 25-28

3.1 Tablets 25-26

3.2 Classification of tablets 26

3.2A According to drug release rate from the tablet 26-27

3.2B According to method of manufacturing 27-28

4.0 Quality control tests for vetenary dosage forms 29-36

4.1 Quality control tests for tablets 29

4.2 Quality control tests for tablets (Compendial tests) 30-36

5.0 Conclusion 37

6.0 References 38-39