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monograph mechanism

Development of Monographs


Monograph 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.

Method Origin 


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 different pharmacopoeias.


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 Figure Above




Acceptance Criteria for Test & Examination of Blood Glucose Test Strips as per ISO 15197:2013new


Turnaround time for testing new

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