can anyone tell that can be use EP monograph instead of BP monograph as the most of monograph are same with parameters. if both are same then what is need of publishing EP and BP separately?
please help and share your views.
@ Kamal Sharma: It is depend in which market you are going to market your product. If the monograph’s parameters complies the both EP & BP. You can Write as EP/BP.
Both pharmacopoeia’s governing body & recommendation through separate pathways. So, being a pharma customer/manufacture/ marketer we respect their process & folllow through documentary process either side as customer/manufacture/ marketer or vendor.
EP — European Pharmacopoeia is a major regional pharmacopoeia which provides common quality standards throughout the pharmaceutical industry in Europe to control the quality of medicines, and the substances used to manufacture them.
BP —The British Pharmacopoeia (BP) is the national pharmacopoeia of the United Kingdom. It is an annual published collection of quality standards for UK medicinal substances. It is used by individuals and organisations involved in pharmaceutical research, development, manufacture and testing.
sir my question is whether we can use monograph of BP instead of EP by writing EP in specification. if yes then what is need of publishing of BP/EP individually?
It is depend in which market you are going to plan for marketing your product i.e. EU other then UK, UK or other ROW country who follow EP or BP formulation.