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IPC to sensitize stakeholders on techniques related to AMM for manufacturing of quality drugs
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Shardul Nautiyal, Mumbai
June 22 , 2021
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The Indian Pharmacopoeia Commission (IPC), an autonomous institution under the Union health ministry, is planning to sensitize stakeholders on the techniques related to alternative microbiological methods (AMM) through a series of webinars for manufacturing of quality drugs.
Microbiological testing is an integral part of the quality management system for manufacturing of drugs. Conventional microbiological methods take a long time to provide results, sometimes up to 14 days from the date of initiation of the test, which is very taxing for the industry.
Numerous AMMs are being used globally for different purposes where significantly less time is required to complete the test, sometimes in hours. IP recently published a draft General Chapter entitled “Approaches to Alternative Microbiological Methods” where it discussed various aspects of this domain. With this, stakeholders have the option of using AMM to replace conventional microbiological testing and shorten the batch release time.
The webinars will cover the importance and applications of AMMs, types of AMMs, validation strategies for AMMs, user requirements specification, risk based approach to select AMMs, product specific method suitability and equivalency testing, use of AMMs in Sterility/MLT testing.
These webinars are useful for decision makers in Quality Assurance, R&D laboratories of pharma/food/testing services/herbal and allied industry, analysts and managers working in the field of microbiological analysis, analysts and officers working in state and Central Government Testing Laboratories, State and Central Regulators for better implementation of the alternative microbiological techniques, faculty members and students of pharmacy/microbiology/life sciences for general understanding of the concept of AMMs.
IPC is created to set standards of drugs in the country. Its basic function is to regularly update the standards required for treatment of diseases prevailing in this region. It publishes official documents for improving quality of medicines by way of adding new and updating existing monographs and General Chapters in the form of Indian Pharmacopoeia (IP).
It further promotes rational use of generic medicines by publishing National Formulary of India (NFI). It prescribes standards for identity, purity and strength of drugs essentially required from the health care perspective of human beings and animals. IPC also provides IP Reference Substances (IPRS) which act as a fingerprint for identification of an article under test and its purity as prescribed in IP.
One of its mandates is to provide awareness and training to various stakeholders about the progress of these activities such as upgradation and inclusion of new monographs and general chapters in IP.
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