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About The Book
Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) comprise the standards for quality management systems that have been majorly accepted as legal in many nations. In order to provide safe and effective products for consumption world-wide, the consumers will certainly follow these standards. GMP and GLP are utilized for quality control purposes pertaining to the manufacturing, sale and material testing of all pharmaceutical products including foods items. These standards ensure the provision for minimal set of requirements for product quality and purity control.
The important advantage of working in a regulated environment is that if the experimental work is conducted even without the aid of computer but is in compliance with GLP, then it is still possible for an inspector to obtain the complete explanation about how and by whom the work was done, who was in control and what equipment was used. It also helps to encounter the register problems and overcome those with the necessary data.
Good Laboratory Practice (GLP) deals with the organization, processes and conditions under which laboratory studies are planned, monitored, performed, reported and recorded. Current Good Manufacturing Practices (cGMPs) also help to establish the foundation for high quality pharmaceuticals through their regulatory standards.
The comprehensive reference content of this book will be helpful for all pharmaceutical professionals pursuing their post graduate degree in pharmacy. This will be very useful especially for explaining the principles of good manufacturing and good laboratory practices along with their importance within a regulated laboratory environment.
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1. Philosophy of Quality Assurance, GMP, CGMP, GLP
2. Who Certification Scheme
3. Monograph Development
4. Self-Inspection and Quality Audit
5. Organization and Personnel Responsibilities
6. Premises
7. Equipment
8. Raw Materials
9. Manufacture and Control on Dosage Forms
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10. Process Quality Controls on Various Dosage Forms
11. Packaging and Labeling Control
12. Quality Control Laboratory
13. Finished Product Release
14. Warehousing
15. Distribution
16. Complaints and Recalls
17. Waste Disposal and Scrap Disposal
18. Good Laboratory Practice
19. Testing of Packaging Material
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