IPC releases revised draft chapter on alternative rapid Microbiological Methods

The draft general chapter on “Approach to Alternative Rapid Microbiological Methods” was uploaded on the IPC website on April 9, 2021 for stakeholder’s comments.

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Last Updated on July 7, 2021 by The Health Master

The Indian Pharmacopoeia Commission (IPC) has released revised draft chapter on approach to alternative rapid microbiological methods (RMM) in coordination with microbiology experts towards making efficacious C-19 drugs.

IPC had earlier recommended stakeholders to follow the draft General Chapter on ‘Approach to Alternative Rapid Microbiological Methods’ as an interim measure in the wake of C-19 second wave.

The draft general chapter on “Approach to Alternative Rapid Microbiological Methods” was uploaded on the IPC website on April 9, 2021 for stakeholder’s comments.

This revised draft chapter provides guidance on the concept, user requirement selection, evaluation, and use of microbiological methods as alternatives to compendial methods where this can lead to efficient microbiological control and improved assurance for the quality of pharmaceutical products.

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The microbiological methods described in Indian Pharmacopoeia effectiveness of antimicrobial preservatives (2.2.2); microbial contamination in non-sterile products (2.2.9); microbiological assay of antibiotics (2.2.10); sterility test (2.2.11) and maintenance, identification, preservation and disposal of microorganisms (2.2.20) are for detection, enumeration and identification of microorganisms.

However, these microbiological test methods are time consuming and slow and in case of sterility test, it takes 14 days to complete the test. The results from these methods cannot be used to take any corrective action in time.

Alternative microbiological methods have shown potential for real-time or near real-time results with the possibility of earlier corrective action. These new methods, if validated and adapted for routine use, can also offer significant improvements in the quality of testing. Alternative methods may be used for raw materials, in-process samples, finished pharmaceutical products, for environment monitoring and for utilities such as water, steam and compressed gasses or wherever applicable for testing of microorganisms etc.

In this chapter, alternative microbiological methods for pharmaceutical products are described. For methods available, the basic principle, the advantages and disadvantages of the method are discussed. It is not the purpose of this chapter to recommend one method/technique over another, nor is it the intention to provide an exclusive or exhaustive list of alternative methods that can be used for pharmaceutical microbiological control.

The information herein may be used, however, in the process of choosing an alternative microbiological method as a supplement or as an alternative to pharmacopoeial microbiological methods and to give guidance on validation of the chosen method.

Alternative methods of analysis may be used for control purposes, provided that the methods used are shown to give results of equivalent accuracy and enable an unequivocal decision to be made as to whether compliance with the standards of the monographs would be achieved if the official methods were used. Automated procedures utilizing the same basic principles as the test procedures given in the monograph may also be used to determine compliance.

Such alternative or automated procedures must be validated and are subject to approval by the authority competent to authorised manufacturer of substance or product.

In the event of doubt or dispute, the methods of the pharmacopoeia are alone authoritative and only the result obtained by the procedure given in the pharmacopoeia is conclusive.

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