Guidance document released for monographs drafting & formatting for Indian Pharmacopoeia: IPC

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

In this Guidance Document, emphasis is on elaborating IP monographs under the categories of active pharmaceutical ingredients (APIs), dosage forms, and pharmaceutics.

A pharmacopoeial monograph provides a factual basis for making an independent and objective judgment about a pharmaceutical substance's quality.

The aim is to guide for drafting clear, unambiguous texts, with similar requirements presented in the same way in each monograph.

The technical part of Pharmacopoeia is broadly divided into the following sections like introduction, general chapters, reference data, available tests, and general notices