Overview

Genotoxic Impurities are known to be present in drug substances and products for the last few decades. They are either present as an impurity or are formed in API and/or Pharmaceuticals products. Testing of new drug substances for the presence of genotoxic impurities is a regulatory requirement and limits of these impurities have been prescribed.

However, the recent recalls of Metformin and Ranitidine by FDA, because of the presence of higher levels of genotoxic NDMA, has raised serious global concerns about the quality and testing of pharmaceutical products. Just over a year ago in 2018, NDMA and NDEA impurities were reported in Valsartan and other Sartans resulting in the recall by FDA and EMA.  

This problem of the presence of Nitrosamine or Nitroso impurities has global implications and ramifications for the Indian pharmaceutical industry as well. The issue with these products, which have been prepared following cGMP and tested following compendial procedures and norms, is of much greater significance and concern because it is difficult to understand where and how the process or product goes wrong. Is the problem related to (a) presence of a toxic impurity in API, or (b) inefficient testing method/equipment or (c) inadequate risk assessment or (d) lack of product and process understanding or (e) stability/storage issue?

In order to better understand this issue and to find the solution to the current problem of nitrosamine impurities, Select Biosciences India had organized two Round Table Meetings in two different Cities so that knowledge and learning of Pharmaceutical and Regulatory Experts in this field can be shared to the maximum people working in Pharmaceutical/API industry.

The first meeting was held in Ahmedabad on December 6, 2019. This meeting was very well attended by the Senior Scientists from the Pharmaceutical Industry and all the pertinent issues were meticulously addressed by the Government, Regulators, and Industry Experts.

The second meeting in this series was held on February 15, 2020, in Hyderabad, India. This meeting was highly cherished by the audience from Pharmaceutical Industries, Bulk drug manufacturers, Pharmaceutical R & D, Private analytical laboratories, as well as technology companies and solution providers. We thank all our Speakers/Experts from CDL Kolkata, CDSCO, Zonal office Hyderabad, World Health Organization, Geneva, Pharmaceutical industries and Technology Companies for their active participation.

The third meeting in this series, namely "Nitrosamine Impurities in API and Pharmaceutical Products - How to Analyze and Control?" is to be held on May 22, 2020, in Chennai, India. This round-table meeting will witness selected expert presentations addressing the issue followed by moderated open discussion wherein the participants will also get a chance to present their views and concerns.  It is envisaged to invite regulators from USFDA/EMA and/or other regulatory bodies as well.

Points of Discussion

1. How good is the criterion to devise specification limits for regulatory acceptance and commercialization? How to fix the limit for new nitrosamine impurities?
2. Discussion on the Most Efficient Method of Testing.
3. How stability evaluation should be performed to check the increase of these carcinogenic impurities during an accelerated and real-time long term evaluation.
4. For Drug substance which is having nitroso group and already genotoxic then for that kind of drug substance the risk assessment for nitrosamine impurity is required or not?

Who Should Attend

Chairman, President, Vice President, Managing Directors, CEO, CSO, Directors, Owners, Proprietors from Pharmaceutical industry (Research, API/Formulation Manufacturing, Analytical, Regulatory) and Testing laboratories as well as Professors/Scientists from Research Institutions who are experts in Pharmaceutical Impurity Profiling, Pharmaceutical Analysis, Stability testing as well as Organic Synthesis.

Type of Participation

Delegate: A delegate can attend the meeting, ask questions and participate in the discussion

Business Delegate: A business delegate can attend the meeting, network during breaks and exchange cards

Technology Expert: A technology expert can attend the meeting, Present Technology Advancements in the field of Analysis and Impurity Profiling, Participate in Discussion (Selected Participants only)