Pharmaceutical Quality Assurance

In the year 2000 I first wrote a book on "Pharmaceutical Manufacturing Documentation". This book mainly dealt with the documents which are required to be created and used in the Pharmaceutical manufacturing operations. The main source of this book was 21CFR Part-211, which deals with the GMP guidelines for pharmaceutical products. This book was received with great enthusiasm by the students of pharmacy and industry both.

Last six years lot of changes took place in the Indian pharma industry and educational field also. Industry grown many fold in terms of pharmaceuticals export markets, covering all underdeveloped, developing and developed countries. Many international regulatory guide lines are now used for meeting the regularity requirements of the importing countries some leading regulatory guide lines are those of W.H.O., M.H.R.A., T.G.A., USFDA and MCC along with many others from Belgium, Germany etc. Academic institutions and universities have included some industry oriented subjects at undergraduate and post graduate level like Pharma documentation, cGMP, Validation, Quality Assurance, Industrial Pharmacy etc.

1. Personnel

2. Surrounding, Buildings And Facilities

3. Equipment

4. Materials Management

5. Quality Management

6. Manufacturing Operations And Control

7. Documentation And Records

8. Pharmaceutical Validation

9. Outsourcing

10. Post Operational Activities

11. Site And Plant Security

12. Safety And Environmental Protection

13. Sterile Pharmaceutical Products

Abbreviations List

Glossary

References

Index