Two earlier editions of this book were well received by pharmaceutical industry, pharmacy faculty, regulatory officers and consultants. The first edition of this book authored by Mr. P.P.Sharma, senior regulatory officer of the Govt. of Delhi was published in 2000. At that time, there was no formal GLP text under Indian regulations. The govt. of India, Ministry of Health & Family Welfare notified GLP under schedule LI of the Drugs and Cosmetics Rules in Nov.,2008 with stipulation that these will come into force after two years of the date of notification. The second edition of the book was published in 2008. Not only Indian GLP have been discussed in the book, but other GLP like OECD GLP guidelines, US FDA GLP have also been referenced.
There are other associated topics without which GLP can not be implemented e.g. inspection and test, sampling, statistical quality control. Several chapters have been included covering these topics. A chapter on laboratory safety has been also included. Appendices, amongst other useful information, have texts of Indian GLP, US FDA GLP, Breeding of and Experiments on Animals(Control and Supervision) Rules, 1998.
India enjoys the status of provisional member of the OECD (Organization for Economic Cooperation and Development) for GLP. Therefore a National GLP Compliance Monitoring Authority has been setup under the Dept. of Science and Technology (DST), Ministry of Science & Technology, Govt. of India. This Authority issues GLP Compliance Certificate required by regulatory authorities of OECD countries. Therefore, a chapter on GLP certification has been included in this edition.
A few Years back it was being contemplated that NABL accrediation will be made mandatory for drug testing laboratories in India. However, it has not been made mandatory. But many drug testing laboratories have gone for NABL accreditation. Many more drug testing laboratories may go for NABL accreditation. Therefore, a chapter on NABL accreditation has been included in this edition.
These developments led to the revision of the book. |
