GMPs and GLPs (Quality Assurance)
  by Aashka Jani / Hina Bagada / Priya Patel
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   ISBN 978-93-85529-09-2; 1st Ed. 2019; pp.viii+408

   Delhi price: 300      Outside Delhi price: 315      Overseas price : 900

 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.


    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

  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