Guidance document: monographs for Indian Pharmacopoeia: IPC

In this Guidance Document, emphasis has been given to elaborate IP monographs under the categories of active pharmaceutical ingredients (APIs), dosage forms, pharmaceutics.

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Last Updated on January 17, 2023 by The Health Master

The Indian Pharmacopoeia Commission (IPC) has released the Guidance Document for Drafting and Formatting of Monographs for Indian Pharmacopoeia (IP) to guide the stakeholders including drug manufacturers, analysts and academicians on drafting of drug monographs before their inclusion in the Indian Pharmacopoeia.

In this Guidance Document, emphasis has been given to elaborate IP monographs under the categories of active pharmaceutical ingredients (APIs), dosage forms, pharmaceutics.

To read or download the above guidance document, click here

IP is a compilation of official standards for drugs manufactured and/or marketed in India. A monograph states the quality or test parameters, the acceptance criteria and details of the tests that are to be performed to determine compliance with the criteria.

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In other words, a pharmacopoeial monograph provides a reliable basis for making an independent and objective judgement as to the quality of a pharmaceutical substance.

As IP standards are statutory, it is important that the contents of monographs are unambiguous, acceptance criteria are clearly spelt out and the methods of evaluation provide all the details for carrying out the tests and assays, including the equipment, reagents and other ancillary materials that are to be used.

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The guidance document is a guide for drafting and elaboration of the monographs to the stakeholders of the IP especially industries, testing laboratories and academicians. The aim is to provide guidance for drafting clear unambiguous texts, with similar requirements presented in the same way in each monograph.

The technical part of pharmacopoeia shall be broadly divided into the following sections like introduction, general chapters, reference data, general tests and general notices.

The scientific director of the Indian Pharmacopoeia Commission shall approve this part after all the contents of the pharmacopoeia have been finalised. It shall briefly give the background to the edition and describe the salient features including the admissions and omissions from the previous edition.

The guidance document bears a lot of relevance as there is a need for regular updation of IP to meet essential requirements for harmonisation of analytical methods in IP with those accepted internationally keeping in view Indian scenario.

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