Round-table Discussion - Overview

The recent recall of Ranitidine by FDA, because of the presence of genotoxic NDMA impurity, has raised serious global concerns about the quality of pharmaceutical products. Just over a year ago in 2018, NDMA and NDEA impurities were reported in Valsartan 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 toxic impurities 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, to find solutions and to collectively decide on the future sustainable course of action, Select Biosciences India is holding a high level Round-table Discussion of the stakeholders involving the regulatory authorities, bulk drug manufacturers, drug product manufacturers, pharmaceutical R & D, private analytical laboratories, industry associations and groups, select academic experts as well as technology companies and solution providers.

This meeting is scheduled to be held in Ahmedabad on December 6, 2019, from 10.00 am to 5.00 pm and is expected to discuss this issue at length. This round-table meeting will witness selected expert presentations addressing the issue followed by an open discussion wherein the expert participants will also get a chance to present their views and concerns. The meeting points will be recorded and key concerns will be forwarded to the Indian regulatory authorities as recommendations of this forum for necessary action.

Points of Discussion

• Where do we stand with respect to the presence of Nitrosamine Impurities in Indian Pharmaceutical Products – Defining the Extent of Issue and Concern? Current overview and Thought Process of US FDA & EMA with respect to the Concern of Impurities
• Influence of Nitroso Impurities Issue on Exports of Indian Pharmaceutical Products
• Understanding the Origin of Nitroso Impurities during Manufacturing and Testing. How good is the criterion to devise specification limits for regulatory acceptance and commercialization?
• Discussion on the Most Efficient Method of Testing for Nitrosamine Impurities. Any Test Report or Data Available from the Government Testing Laboratories
• How stability evaluation should be performed to check the increase of these carcinogenic nitrosamine impurities during accelerated and real-time long term evaluation.

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.

Expected Outcomes of the Meeting

• A better understanding of the extent of problem/concern of impurities in pharmaceutical products and the viewpoint of regulatory authorities on how to address this issue of Nitrosamine Impurities
• Impact of impurities issue on Indian Exports
• A better understanding of the origin of Nitrosamine Impurities and best testing practices and procedures
• Issues and Concerns of the Pharmaceutical Industry and Key Recommendation for Submission to Regulatory Authorities

Type of Participation

Expert Participant: Attend the meeting, Present Views on Either of the Points of Discussion, Participate Actively in Discussion (Limited Seats)
Delegate: Attend the meeting only
Business Delegate: Attending and Networking during breaks
Technology Expert: Attend the meeting, Present Technology Advancements in the field of Analysis and Impurity Profiling, Participate in Discussion (Selected Participants)

Participation of Technology Companies

Proposals are invited from the technology companies pioneering instruments and solutions related to the analysis of pharmaceutical impurities and would like to present technical solutions to the current issue of Nitrosamine Impurities. The participation and presentation are limited to the Scientists/Application Specialists having specific experience related to pharmaceutical impurity profiling and will be by selection and subject to availability of presentation slots. For details, please write to s.bajaj@selectbio.in or call 9814412082, 7696525050, 7696125050 or WhatsApp 9041725050.