The current edition is the seventh edition. While updating the book, author has taken in to consideration various supplementary GMP guidelines published by WHO and EU Guidance on GMP. In this edition, three new chapters have been added and include:
Supplementary GMPs for Herbal Medicines, GMP Considerations for Investigational Pharmaceutical Products for Clinical Trials, GMPs for Homoeopathic Medicines.
ICH has published ICH Q10 which is a document on Pharmaceutical Quality System. Participating countries of ICH are in the process of incorporating the systems mentioned in the document in their regulations. CAPA (Corrective Action and Preventive Action) system is an element of both ICH Q10 as well as ISO:9000. Overview of ICH Q10 and CAPA system has been included in chapter 10 of the book.
Amongst the appendices, the book has texts of Indian GMP, WHO GMP, US FDA GMP. |
