PHARMACEUTICAL QUALITY ASSURANCE – For TY BPharm – Semester 6 | Anusuya R Karhi, Binda Sukmaran | Nirali Prakashan

1. Quality Assurance and Quality Management Concept
2. Total Quality Management
3. International Conference on Harmonization (ICH)
4. Pharmaceutical Quality by Design
5. Introduction to ISO 9000 and ISO 14000
6. NABL Accredition
7. Organization and Personnel
8. Premises-Design, Construction Layout and Maintenance
9. Equipment and Raw Materials
10. Quality Control
11. Good Laboratory Practices for Non-Clinical Laboratories
12. Complaint, Recalls and Waste Disposal
13. Documentation in Pharmaceutical Industry
14. Calibration and Validation
15. Good Warehousing Practice and Materials Management
* References

About the Book :

In a welcome move, the Pharmacy Council of India has recently re-structured the syllabus of the Bachelor of Pharmacy course. In the effort to make the content more relevant to the practice of pharmacy in its current form, we now find new, important subjects introduced, and Pharmaceutical Quality Assurance is one of them.

While quality is the single-most important requirement for any product, it becomes even more critical in the pharmaceutical industry where patients rely on medicines to cure, prevent and mitigate diseases. From the times when mere quality control testing was sufficient to approve products as fit for use, we have now progressed to the realization that quality must be built into drug products from the very initial design phase. Quality assurance (QA) comprises the sum total of all that goes into ensuring that products manufactured are of the intended quality that makes them fit for use. Understanding the several different aspects of QA is therefore a vital first step in working towards attaining desired quality products.