development provides information on the methods described in the
pharmacopoeia for the analysis of Biotech Drug Substance and Biotech
Finished Drug product. The method of origin and phases of development are
the key integral components in the development process.
Proposal of new or revised methods for inclusion are
often provided by the manufacturers and other users of the pharmacopoeia
either in response to a request from IPC- Secretariat or National Control
Laboratory. All proposals for new and revised methods for publication are
carefully examined by preparing a comparative profile of existing in
Any method that is to be considered to be inclusion
in a monograph has to be suitable for pharmacopoeial purposes and where
ever possible be accompanied by supporting data.
The development phases of monographs
were initiated as per stages described in the schematic representation in